Trial Outcomes & Findings for A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (NCT NCT05374525)
NCT ID: NCT05374525
Last Updated: 2025-12-15
Results Overview
The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
287 participants
Primary outcome timeframe
At Month 12
Results posted on
2025-12-15
Participant Flow
A total of 17 Clinics were randomized to Dynamic Implementation and Routine Implementation arms. In these clinics, a total of 201 patient study participants (PSPs) were enrolled in the study and all of them received study treatment and 86 Staff Study Participants (SSPs) were enrolled that included healthcare providers, nurses, staff performing injections, clinic administrators, pharmacists and laboratory staff.
SSPs provided input through surveys and semi-structured interviews. Baseline characteristics and adverse events for SSP were not collected as it was not required per study design.
Unit of analysis: Clinics
Participant milestones
| Measure |
Dynamic Implementation (DI)
The DI arm evaluated the feasibility of APRETUDE delivery with implementation supports. Clinics randomized to DI received enhanced toolkits, a digital health end to end implementation strategy; and implementation facilitation.
|
Routine Implementation (RI)
The RI arm evaluated the feasibility of APRETUDE delivery without implementation supports. Sites randomized to RI had access to the standard toolkits for SSPs and PSPs that were available for APRETUDE to use as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
173 11
|
114 6
|
|
Overall Study
PSP
|
117 11
|
84 6
|
|
Overall Study
SSP
|
56 11
|
30 6
|
|
Overall Study
COMPLETED
|
137 11
|
95 6
|
|
Overall Study
NOT COMPLETED
|
36 0
|
19 0
|
Reasons for withdrawal
| Measure |
Dynamic Implementation (DI)
The DI arm evaluated the feasibility of APRETUDE delivery with implementation supports. Clinics randomized to DI received enhanced toolkits, a digital health end to end implementation strategy; and implementation facilitation.
|
Routine Implementation (RI)
The RI arm evaluated the feasibility of APRETUDE delivery without implementation supports. Sites randomized to RI had access to the standard toolkits for SSPs and PSPs that were available for APRETUDE to use as needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
26
|
8
|
Baseline Characteristics
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
Baseline characteristics by cohort
| Measure |
Dynamic Implementation (DI) - PSP
n=117 Participants
Men who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.
|
Routine Implementation (RI) - PSP
n=84 Participants
MSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 Years
STANDARD_DEVIATION 11.16 • n=9 Participants
|
37.8 Years
STANDARD_DEVIATION 10.76 • n=32 Participants
|
37.7 Years
STANDARD_DEVIATION 10.97 • n=18 Participants
|
|
Sex/Gender, Customized
Cisgender Man
|
107 Participants
n=9 Participants
|
82 Participants
n=32 Participants
|
189 Participants
n=18 Participants
|
|
Sex/Gender, Customized
Transgender Man
|
10 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
12 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
8 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Black of African American
|
19 Participants
n=9 Participants
|
29 Participants
n=32 Participants
|
48 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
2 Participants
n=9 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
2 Participants
n=9 Participants
|
0 Participants
n=32 Participants
|
2 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
15 Participants
n=9 Participants
|
2 Participants
n=32 Participants
|
17 Participants
n=18 Participants
|
|
Race/Ethnicity, Customized
White
|
72 Participants
n=9 Participants
|
47 Participants
n=32 Participants
|
119 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: At Month 12Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI)
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=52 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs
|
4.27 Scores on a scale
Standard Deviation 0.68
|
4.37 Scores on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome assesses the change in FIM-INT for SSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=48 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in FIM Score Assessed for SSPs
Month 4 compared to baseline (BL)
|
0.08 Scores on a scale
Standard Deviation 0.59
|
-0.29 Scores on a scale
Standard Deviation 0.92
|
|
Change From Baseline in FIM Score Assessed for SSPs
Month 12 compared to BL
|
-0.11 Scores on a scale
Standard Deviation 0.86
|
-0.01 Scores on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points.
Perception of facilitators to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked about the facilitators of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=10 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=14 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Clinic being flexible with scheduling (injection/ lab visits)
|
1 Participants
|
5 Participants
|
|
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Scheduling appointments in advance
|
0 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Training and consistent information provided to staff
|
0 Participants
|
5 Participants
|
|
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Increased communication for vulnerable populations
|
1 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Previous experience with CABENUVA/ APRETUDE
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points.
Perception of barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs were asked about the barriers/challenges of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=10 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=14 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Follow-up with pharmacies needed to obtain APRETUDE
|
2 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Staff burden to integrate the new process
|
3 Participants
|
7 Participants
|
|
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Complex team coordination
|
2 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Insurance challenges related to infrastructure
|
2 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12
Infrastructure Logistic challenges
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection every 2 months seems easy in my life) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=77 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=105 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean FIM Score Assessed for PSPs
Month 6
|
4.46 Scores on a scale
Standard Deviation 0.73
|
4.35 Scores on a scale
Standard Deviation 0.75
|
|
Mean FIM Score Assessed for PSPs
Baseline
|
4.51 Scores on a scale
Standard Deviation 0.70
|
4.33 Scores on a scale
Standard Deviation 0.77
|
|
Mean FIM Score Assessed for PSPs
Month 12
|
4.46 Scores on a scale
Standard Deviation 0.72
|
4.36 Scores on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=77 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=105 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs
Baseline
|
4.41 Scores on a scale
Standard Deviation 0.68
|
4.46 Scores on a scale
Standard Deviation 0.69
|
|
Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs
Month 6
|
4.57 Scores on a scale
Standard Deviation 0.55
|
4.57 Scores on a scale
Standard Deviation 0.64
|
|
Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs
Month 12
|
4.60 Scores on a scale
Standard Deviation 0.67
|
4.61 Scores on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The implementation science questionnaire (ISQ) used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Very Positive
|
52 Participants
|
72 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Somewhat negative
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Very negative
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Very Positive
|
64 Participants
|
79 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Somewhat Positive
|
10 Participants
|
19 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Neither positive nor negative
|
1 Participants
|
7 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Somewhat negative
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Very negative
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Baseline - Overall, how are you feeling about taking APRETUDE? · Missing
|
9 Participants
|
12 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Somewhat Positive
|
9 Participants
|
16 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Neither positive nor negative
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Somewhat negative
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Very negative
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 6 - Overall, how are you feeling about taking APRETUDE? · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Very Positive
|
55 Participants
|
66 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Somewhat Positive
|
7 Participants
|
10 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Neither positive nor negative
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE
At Month 12 - Overall, how are you feeling about taking APRETUDE? · Missing
|
21 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated how acceptable it was for them to go to the clinic for APRETUDE injections. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · Somewhat acceptable
|
6 Participants
|
8 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · Somewhat acceptable
|
5 Participants
|
11 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · Very acceptable
|
55 Participants
|
60 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · Acceptable
|
19 Participants
|
31 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · Somewhat acceptable
|
2 Participants
|
10 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · A little acceptable
|
0 Participants
|
4 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · Not at all acceptable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Baseline - How acceptable is coming to the clinic every 2 months for an injection? · Missing
|
8 Participants
|
12 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · Very acceptable
|
40 Participants
|
49 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · Acceptable
|
16 Participants
|
31 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · A little acceptable
|
0 Participants
|
3 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · Not at all acceptable
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 6 - How acceptable is coming to the clinic every 2 months for an injection? · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · Very acceptable
|
39 Participants
|
41 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · Acceptable
|
18 Participants
|
21 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · A little acceptable
|
1 Participants
|
3 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · Not at all acceptable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection
At Month 12 - How acceptable is coming to the clinic every 2 months for an injection? · Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated if they would recommend APRETUDE to others. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Completely agree
|
52 Participants
|
64 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Neither agree nor disagree
|
0 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Disagree
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Completely disagree
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Completely agree
|
49 Participants
|
72 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 6 - I would recommend APRETUDE to other people who could benefit from it · Agree
|
12 Participants
|
18 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Agree
|
9 Participants
|
12 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Neither agree nor disagree
|
2 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Disagree
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Completely disagree
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE
At Month 12 - I would recommend APRETUDE to other people who could benefit from it · Missing
|
21 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on the ease or difficulty of scheduling appointments at the clinic. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Somewhat difficult
|
2 Participants
|
5 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Very easy
|
46 Participants
|
60 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Somewhat easy
|
13 Participants
|
20 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Neither easy nor difficult
|
3 Participants
|
5 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Somewhat difficult
|
1 Participants
|
6 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Very difficult
|
0 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · I have not scheduled any appointments at the clinic/practice
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 6- How easy or difficult is it to schedule appointments for your injections? · Missing
|
21 Participants
|
24 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Very easy
|
46 Participants
|
49 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Somewhat easy
|
10 Participants
|
15 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Neither easy nor difficult
|
4 Participants
|
6 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Very difficult
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · I have not scheduled any appointments at the clinic/practice
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling
Month 12- How easy or difficult is it to schedule appointments for your injections? · Missing
|
21 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on ease or difficulty of rescheduling appointments at the clinic. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=63 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=93 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · Very easy
|
25 Participants
|
44 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · Somewhat easy
|
17 Participants
|
14 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · Neither easy nor difficult
|
4 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · Somewhat difficult
|
2 Participants
|
6 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · Very difficult
|
1 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 6 - How easy or difficult is it to reschedule appointments for your injections? · I have not needed to reschedule any appointments
|
14 Participants
|
25 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · Very easy
|
30 Participants
|
39 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · Somewhat easy
|
17 Participants
|
13 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · Neither easy nor difficult
|
4 Participants
|
4 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · Somewhat difficult
|
6 Participants
|
8 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · Very difficult
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling
Month 12- How easy or difficult is it to reschedule appointments for your injections? · I have not needed to reschedule any appointments
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.
Outcome measures
| Measure |
RI - SSP
n=61 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=87 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in AIM Score Assessed for PSPs
Month 6 compared to BL
|
0.20 Scores on a scale
Standard Deviation 0.72
|
0.17 Scores on a scale
Standard Deviation 0.66
|
|
Change From Baseline in AIM Score Assessed for PSPs
Month 12 compared to BL
|
0.19 Scores on a scale
Standard Deviation 0.87
|
0.27 Scores on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome assesses the change in FIM-INT for PSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection every 2 months seems easy in my life) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to baseline.
Outcome measures
| Measure |
RI - SSP
n=61 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=87 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in FIM Score Assessed for PSPs
Month 12 compared to BL
|
-0.01 Scores on a scale
Standard Deviation 0.92
|
0.01 Scores on a scale
Standard Deviation 0.71
|
|
Change From Baseline in FIM Score Assessed for PSPs
Month 6 compared to BL
|
0.00 Scores on a scale
Standard Deviation 0.89
|
0.01 Scores on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to Baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE and how acceptable it was for them to go to the clinic for APRETUDE injections. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL. Q2M = a schedule of injection administration at every 2 months.
Outcome measures
| Measure |
RI - SSP
n=63 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=92 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - Participant' acceptability for injection visits Q2M - A little acceptable
|
0.0 Percentage of participants
|
-0.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - Participant' acceptability for injection visits Q2M - A little acceptable
|
1.6 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - How the participant felt about taking APRETUDE - Very positive
|
-2.8 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - How the participant felt about taking APRETUDE - Somewhat positive
|
1.0 Percentage of participants
|
-0.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6-How the participant felt about taking APRETUDE- Neither positive nor negative
|
0.3 Percentage of participants
|
-4.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - How the participant felt about taking APRETUDE - Somewhat negative
|
1.6 Percentage of participants
|
2.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - How the participant felt about taking APRETUDE - Very negative
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - How the participant felt about taking APRETUDE-Very positive
|
2.0 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - How the participant felt about taking APRETUDE-Somewhat positive
|
-2.2 Percentage of participants
|
-5.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12-How the participant felt about taking APRETUDE-Neither positive nor negative
|
0.3 Percentage of participants
|
-6.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - How the participant felt about taking APRETUDE-Somewhat negative
|
0.0 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - How the participant felt about taking APRETUDE-Very negative
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - Participant' acceptability for injection visits Q2M - Very acceptable
|
-8.9 Percentage of participants
|
-3.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - Participant' acceptability for injection visits Q2M - Acceptable
|
0.4 Percentage of participants
|
4.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - Participant' acceptability for injection visits Q2M - Somewhat acceptable
|
6.9 Percentage of participants
|
-0.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M6 - Participant' acceptability for injection visits Q2M - Not at all acceptable
|
1.6 Percentage of participants
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - Participant' acceptability for injection visits Q2M - Very acceptable
|
-10.5 Percentage of participants
|
-3.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - Participant' acceptability for injection visits Q2M - Acceptable
|
3.6 Percentage of participants
|
-1.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - Participant' acceptability for injection visits Q2M - Somewhat acceptable
|
5.3 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses
Change BL to M12 - Participant' acceptability for injection visits Q2M - Not at all acceptable
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
Facilitators to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perception of the facilitators of feasibility and acceptability of APRETUDE intervention. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
Perceived effectiveness provides peace of mind
|
2 Participants
|
7 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
Discomfort becoming more manageable
|
5 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
APRETUDE met their expectations
|
18 Participants
|
15 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
APRETUDE positive experience so far
|
20 Participants
|
23 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
Positive Experiences and General Satisfaction
|
12 Participants
|
14 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
Convenience and Ease of Use
|
11 Participants
|
15 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
Reduced anxiety about taking oral PrEP
|
15 Participants
|
5 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
HIV protection
|
7 Participants
|
10 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12
APRETUDE more convenient than expected
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
Barriers to feasibility and acceptability of APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perspectives on the barriers and challenges of feasibility and acceptability of APRETUDE intervention. Timeframe for evaluation of this outcome measure is through M12 (equivalent M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perception of Barriers to Feasibility and Acceptability of APRETUDE Through Month 12
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 4 and Month 12Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM-TEL services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean FIM Score for Telehealth Delivery Assessed for SSPs
Month 4
|
4.08 Scores on a scale
Standard Deviation 1.20
|
4.13 Scores on a scale
Standard Deviation 0.90
|
|
Mean FIM Score for Telehealth Delivery Assessed for SSPs
Baseline
|
3.43 Scores on a scale
Standard Deviation 1.23
|
4.01 Scores on a scale
Standard Deviation 0.83
|
|
Mean FIM Score for Telehealth Delivery Assessed for SSPs
Month 12
|
4.22 Scores on a scale
Standard Deviation 1.30
|
4.26 Scores on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 4 and Month 12Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
The AIM-TEL services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean AIM Score for Telehealth Delivery Assessed for SSPs
Baseline
|
3.26 Scores on a scale
Standard Deviation 1.38
|
4.09 Scores on a scale
Standard Deviation 0.82
|
|
Mean AIM Score for Telehealth Delivery Assessed for SSPs
Month 4
|
3.98 Scores on a scale
Standard Deviation 1.16
|
4.16 Scores on a scale
Standard Deviation 0.78
|
|
Mean AIM Score for Telehealth Delivery Assessed for SSPs
Month 12
|
4.17 Scores on a scale
Standard Deviation 1.28
|
4.07 Scores on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 4 and Month 12Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 1 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · Yes
|
28 Participants
|
54 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 4 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · Yes
|
10 Participants
|
29 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 4 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · No
|
14 Participants
|
15 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 12 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · Yes
|
9 Participants
|
30 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 1 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · No
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 1 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · I Don't Know
|
2 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 4 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · I Don't Know
|
5 Participants
|
7 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 12 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · No
|
12 Participants
|
11 Participants
|
|
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery
Month 12 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? · I Don't Know
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12Population: Analysis was performed on the SSPs who completed at least one survey at any time point. The use and adoption of these telehealth services were only assessed among DI SSPs at M4 but were assessed among both DI and RI SSPs at M12.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about which telehealth services/systems were used at their clinic/practice to deliver APRETUDE during the PILLAR study. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=9 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Yes, at my clinic's service/system
|
0 Participants
|
14 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Yes, services/systems offered through PILLAR study
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection Administration: home health nurse to administer injection · Yes, services/systems offered through PILLAR study
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection Administration: home health nurse to administer injection · No
|
0 Participants
|
17 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Yes, at my clinic's service/system
|
6 Participants
|
24 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Video/virtual consultations for initial and follow-up visits · I don't know
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection Administration: home health nurse to administer injection · I don't know
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection appointment reminders: text/digital/email · No
|
3 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · No
|
0 Participants
|
8 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · I don't know
|
0 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Yes, at my clinic's service/system
|
0 Participants
|
23 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Yes, services/systems offered through PILLAR study
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Video/virtual consultations for initial and follow-up visits · No
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Video/virtual consultations for initial and follow-up visits · I don't know
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection Administration: home health nurse to administer injection · Yes, at my clinic's service/system
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection Administration: home health nurse to administer injection · I don't know
|
0 Participants
|
5 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection appointment reminders: text/digital/email · Yes, at my clinic's service/system
|
0 Participants
|
21 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection appointment reminders: text/digital/email · Yes, services/systems offered through PILLAR study
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection appointment reminders: text/digital/email · No
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - Injection appointment reminders: text/digital/email · I don't know
|
0 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - HIV testing services: at home nurse testing · Yes, at my clinic's service/system
|
0 Participants
|
8 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - HIV testing services: at home nurse testing · Yes, services/systems offered through PILLAR study
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - HIV testing services: at home nurse testing · No
|
0 Participants
|
14 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 4 - HIV testing services: at home nurse testing · I don't know
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Yes, at my clinic's service/system
|
5 Participants
|
21 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Yes, services/systems offered through PILLAR study
|
1 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · No
|
3 Participants
|
5 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · I don't know
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Yes, services/systems offered through PILLAR study
|
1 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Video/virtual consultations for initial and follow-up visits · No
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection Administration: home health nurse to administer injection · Yes, at my clinic's service/system
|
1 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection Administration: home health nurse to administer injection · Yes, services/systems offered through PILLAR study
|
1 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection Administration: home health nurse to administer injection · No
|
7 Participants
|
16 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection appointment reminders: text/digital/email · Yes, at my clinic's service/system
|
5 Participants
|
23 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection appointment reminders: text/digital/email · Yes, services/systems offered through PILLAR study
|
1 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - Injection appointment reminders: text/digital/email · I don't know
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - HIV testing services: at home nurse testing · Yes, at my clinic's service/system
|
1 Participants
|
9 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - HIV testing services: at home nurse testing · Yes, services/systems offered through PILLAR study
|
1 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - HIV testing services: at home nurse testing · No
|
7 Participants
|
13 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used
Month 12 - HIV testing services: at home nurse testing · I don't know
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. The use and adoption of these telehealth services were only assessed among DI SSPs at M4, but were assessed among both DI and RI SSPs at M12.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the helpfulness of the telehealth services/systems used at their clinic/practice. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=7 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=26 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Helpful
|
1 Participants
|
6 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Very helpful
|
0 Participants
|
10 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Helpful
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Online system for scheduling/rescheduling consultations and injection appointments · I have not personally used this
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Very helpful
|
0 Participants
|
14 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Helpful
|
0 Participants
|
5 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Somewhat helpful
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Video/virtual consultations for initial and follow-up visits · I have not personally used this
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · Very helpful
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · Helpful
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection Administration: home health nurse to administer injection · I have not personally used this
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · Very helpful
|
0 Participants
|
14 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · Helpful
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - Injection appointment reminders: text/digital/email · I have not personally used this
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · Very helpful
|
0 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · Helpful
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 4 - HIV testing services: at home nurse testing · I have not personally used this
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Very helpful
|
4 Participants
|
9 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Helpful
|
2 Participants
|
7 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Somewhat helpful
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Online system for scheduling/rescheduling consultations and injection appointments · I have not personally used this
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Very helpful
|
4 Participants
|
13 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Somewhat helpful
|
2 Participants
|
3 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Video/virtual consultations for initial and follow-up visits · I have not personally used this
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · Very helpful
|
1 Participants
|
5 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · Helpful
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection Administration: home health nurse to administer injection · I have not personally used this
|
1 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · Very helpful
|
4 Participants
|
16 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · Helpful
|
2 Participants
|
4 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · A little helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - Injection appointment reminders: text/digital/email · I have not personally used this
|
0 Participants
|
2 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · Very helpful
|
1 Participants
|
9 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · Helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · Somewhat helpful
|
0 Participants
|
1 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · A little helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used
Month 12 - HIV testing services: at home nurse testing · I have not personally used this
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM telehealth services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for APRETUDE seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).
Outcome measures
| Measure |
RI - SSP
n=10 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=28 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs
Month 4 compared to BL
|
0.20 Scores on a scale
Standard Deviation 1.21
|
-0.11 Scores on a scale
Standard Deviation 1.21
|
|
Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs
Month 12 compared to BL
|
0.16 Scores on a scale
Standard Deviation 0.64
|
-0.06 Scores on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome assesses the change in AIM telehealth services for SSPs over time. The AIM telehealth services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).
Outcome measures
| Measure |
RI - SSP
n=10 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=28 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs
Month 4 compared to BL
|
0.53 Scores on a scale
Standard Deviation 1.21
|
-0.13 Scores on a scale
Standard Deviation 0.92
|
|
Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs
Month 12 compared to BL
|
0.41 Scores on a scale
Standard Deviation 1.02
|
-0.38 Scores on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12 compared to Baseline (Month 1)Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=52 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M4 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? - YES
|
-58.9 Percentage of participants
|
-39.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M4 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? - NO
|
48.3 Percentage of participants
|
27.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M4-Does clinic/practice use any form of telehealth for APRETUDE delivery?-I DON'T KNOW
|
10.6 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M12 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? - YES
|
-62.3 Percentage of participants
|
-38.7 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M12 - Does your clinic/practice use any form of telehealth for APRETUDE delivery? - NO
|
41.4 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery
Change BL to M12-Does clinic/practice use any form of telehealth for APRETUDE delivery?-I DON'T KNOW
|
20.9 Percentage of participants
|
19.4 Percentage of participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services seems easy in my life) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=76 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=105 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean FIM Score for Telehealth Delivery Assessed for PSPs
Baseline
|
4.15 Scores on a scale
Standard Deviation 0.97
|
4.40 Scores on a scale
Standard Deviation 0.72
|
|
Mean FIM Score for Telehealth Delivery Assessed for PSPs
Month 6
|
4.19 Scores on a scale
Standard Deviation 0.76
|
4.56 Scores on a scale
Standard Deviation 0.56
|
|
Mean FIM Score for Telehealth Delivery Assessed for PSPs
Month 12
|
4.38 Scores on a scale
Standard Deviation 0.70
|
4.25 Scores on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timepoints during which this outcome measure was evaluated were BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI)
Outcome measures
| Measure |
RI - SSP
n=76 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=105 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean AIM Score for Telehealth Delivery Assessed for PSPs
Baseline
|
4.13 Scores on a scale
Standard Deviation 0.91
|
4.32 Scores on a scale
Standard Deviation 0.76
|
|
Mean AIM Score for Telehealth Delivery Assessed for PSPs
Month 6
|
4.25 Scores on a scale
Standard Deviation 0.70
|
4.56 Scores on a scale
Standard Deviation 0.57
|
|
Mean AIM Score for Telehealth Delivery Assessed for PSPs
Month 12
|
4.27 Scores on a scale
Standard Deviation 0.67
|
4.21 Scores on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Baseline- Have you used any of the telehealth care options that your clinic offers? · Yes
|
48 Participants
|
72 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Baseline- Have you used any of the telehealth care options that your clinic offers? · No
|
10 Participants
|
14 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Baseline- Have you used any of the telehealth care options that your clinic offers? · I don't know
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Baseline- Have you used any of the telehealth care options that your clinic offers? · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6 - Have you used telehealth for any APRETUDE services in the last 6 months? · Yes
|
24 Participants
|
41 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6 - Have you used telehealth for any APRETUDE services in the last 6 months? · No
|
34 Participants
|
49 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6 - Have you used telehealth for any APRETUDE services in the last 6 months? · I don't know
|
7 Participants
|
4 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6 - Have you used telehealth for any APRETUDE services in the last 6 months? · Missing
|
19 Participants
|
23 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Doctor ordering HIV test at a lab near home to take the test · Yes
|
9 Participants
|
17 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Doctor ordering HIV test at a lab near home to take the test · No
|
14 Participants
|
22 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Doctor ordering HIV test at a lab near home to take the test · I don't know
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Doctor ordering HIV test at a lab near home to take the test · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give an HIV test · Yes
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give an HIV test · No
|
21 Participants
|
36 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give an HIV test · I don't know
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give an HIV test · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Receiving reminders about scheduled injection appointment · Yes
|
22 Participants
|
36 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Receiving reminders about scheduled injection appointment · No
|
1 Participants
|
4 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Receiving reminders about scheduled injection appointment · I don't know
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Receiving reminders about scheduled injection appointment · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Scheduling injection appointment online · Yes
|
15 Participants
|
24 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Scheduling injection appointment online · No
|
8 Participants
|
15 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Scheduling injection appointment online · I don't know
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Scheduling injection appointment online · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give the injection · Yes
|
2 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give the injection · No
|
21 Participants
|
38 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give the injection · I don't know
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 6- TEL services received: Nurse coming home to give the injection · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12 - Have you used telehealth for any APRETUDE services in the last 6 months? · Yes
|
25 Participants
|
29 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12 - Have you used telehealth for any APRETUDE services in the last 6 months? · No
|
38 Participants
|
47 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12 - Have you used telehealth for any APRETUDE services in the last 6 months? · I don't know
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12 - Have you used telehealth for any APRETUDE services in the last 6 months? · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Doctor ordering HIV test at a lab near home to take the test · Yes
|
10 Participants
|
11 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Doctor ordering HIV test at a lab near home to take the test · No
|
13 Participants
|
17 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Doctor ordering HIV test at a lab near home to take the test · I don't know
|
2 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Doctor ordering HIV test at a lab near home to take the test · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give an HIV test · Yes
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give an HIV test · No
|
23 Participants
|
26 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give an HIV test · I don't know
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give an HIV test · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Receiving reminders about scheduled injection appointment · Yes
|
25 Participants
|
28 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Receiving reminders about scheduled injection appointment · No
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Receiving reminders about scheduled injection appointment · I don't know
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Receiving reminders about scheduled injection appointment · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Scheduling injection appointment online · Yes
|
13 Participants
|
16 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Scheduling injection appointment online · No
|
12 Participants
|
13 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Scheduling injection appointment online · I don't know
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Scheduling injection appointment online · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give the injection · Yes
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give the injection · No
|
23 Participants
|
25 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give the injection · I don't know
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE
Month 12- TEL services received: Nurse coming home to give the injection · Missing
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how comfortable it was to use various telehealth services for APRETUDE. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=36 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give an HIV test · Neither comfortable nor uncomfortable
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Scheduling injection appointment online · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give the injection · Very comfortable
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give the injection · Somewhat uncomfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Receiving reminders about scheduled injection appointment · Very comfortable
|
21 Participants
|
26 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming home to give the injection · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Doctor ordering HIV test at a lab near home to take the test · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Doctor ordering HIV test at a lab near home to take the test · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give an HIV test · Very comfortable
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give an HIV test · Somewhat comfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Doctor ordering HIV test at a lab near home to take the test · Very comfortable
|
8 Participants
|
12 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Doctor ordering HIV test at a lab near home to take the test · Somewhat comfortable
|
1 Participants
|
4 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Doctor ordering HIV test at a lab near home to take the test · Neither comfortable nor uncomfortable
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give an HIV test · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give an HIV test · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Receiving reminders about scheduled injection appointment · Very comfortable
|
20 Participants
|
33 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Receiving reminders about scheduled injection appointment · Somewhat comfortable
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Receiving reminders about scheduled injection appointment · Neither comfortable nor uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Receiving reminders about scheduled injection appointment · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Receiving reminders about scheduled injection appointment · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Scheduling injection appointment online · Very comfortable
|
13 Participants
|
20 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Scheduling injection appointment online · Somewhat comfortable
|
1 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Scheduling injection appointment online · Neither comfortable nor uncomfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- Scheduling injection appointment online · Somewhat uncomfortable
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give the injection · Somewhat comfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give the injection · Neither comfortable nor uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 6- A nurse coming home to give the injection · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Doctor ordering HIV test at a lab near home to take the test · Very comfortable
|
8 Participants
|
11 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Doctor ordering HIV test at a lab near home to take the test · Somewhat comfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Doctor ordering HIV test at a lab near home to take the test · Neither comfortable nor uncomfortable
|
2 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Doctor ordering HIV test at a lab near home to take the test · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Doctor ordering HIV test at a lab near home to take the test · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming to home to give an HIV test · Very comfortable
|
2 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming to home to give an HIV test · Somewhat comfortable
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming to home to give an HIV test · Neither comfortable nor uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming to home to give an HIV test · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming to home to give an HIV test · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Receiving reminders about scheduled injection appointment · Somewhat comfortable
|
2 Participants
|
2 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Receiving reminders about scheduled injection appointment · Neither comfortable nor uncomfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Receiving reminders about scheduled injection appointment · Somewhat uncomfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Receiving reminders about scheduled injection appointment · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Scheduling injection appointment online · Very comfortable
|
11 Participants
|
15 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Scheduling injection appointment online · Somewhat comfortable
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Scheduling injection appointment online · Neither comfortable nor uncomfortable
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Scheduling injection appointment online · Somewhat uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- Scheduling injection appointment online · Not comfortable at all
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming home to give the injection · Very comfortable
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming home to give the injection · Somewhat comfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming home to give the injection · Neither comfortable nor uncomfortable
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services
Month 12- A nurse coming home to give the injection · Not comfortable at all
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how convenient it was to use various telehealth services for APRETUDE. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=36 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Doctor ordering HIV test at a lab near home to take the test · Neither convenient nor inconvenient
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give an HIV test · Very convenient
|
2 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give an HIV test · Somewhat convenient
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Doctor ordering HIV test at a lab near home to take the test · Very convenient
|
9 Participants
|
11 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give an HIV test · Neither convenient nor inconvenient
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give an HIV test · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give an HIV test · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Receiving reminders about scheduled injection appointment · Very convenient
|
18 Participants
|
31 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Receiving reminders about scheduled injection appointment · Somewhat convenient
|
4 Participants
|
4 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Receiving reminders about scheduled injection appointment · Neither convenient nor inconvenient
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Receiving reminders about scheduled injection appointment · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Receiving reminders about scheduled injection appointment · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Scheduling your injection appointment online · Very convenient
|
13 Participants
|
19 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Scheduling your injection appointment online · Somewhat convenient
|
1 Participants
|
3 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Scheduling your injection appointment online · Neither convenient nor inconvenient
|
0 Participants
|
2 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Scheduling your injection appointment online · Somewhat inconvenient
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Scheduling your injection appointment online · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give the injection · Very convenient
|
1 Participants
|
2 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give the injection · Somewhat convenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give the injection · Neither convenient nor inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give the injection · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- A nurse coming home to give the injection · Very inconvenient
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Doctor ordering HIV test at a lab near home to take the test · Somewhat convenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Doctor ordering HIV test at a lab near home to take the test · Neither convenient nor inconvenient
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Doctor ordering HIV test at a lab near home to take the test · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Doctor ordering HIV test at a lab near home to take the test · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give an HIV test · Very convenient
|
2 Participants
|
2 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give an HIV test · Somewhat convenient
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give an HIV test · Neither convenient nor inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give an HIV test · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give an HIV test · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Receiving reminders about scheduled injection appointment · Very convenient
|
22 Participants
|
28 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Receiving reminders about scheduled injection appointment · Somewhat convenient
|
2 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Receiving reminders about scheduled injection appointment · Neither convenient nor inconvenient
|
1 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Receiving reminders about scheduled injection appointment · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Receiving reminders about scheduled injection appointment · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Scheduling your injection appointment online · Very convenient
|
11 Participants
|
14 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Scheduling your injection appointment online · Somewhat convenient
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Scheduling your injection appointment online · Neither convenient nor inconvenient
|
1 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Scheduling your injection appointment online · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- Scheduling your injection appointment online · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Doctor ordering HIV test at a lab near home to take the test · Very convenient
|
8 Participants
|
12 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Doctor ordering HIV test at a lab near home to take the test · Somewhat convenient
|
0 Participants
|
3 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Doctor ordering HIV test at a lab near home to take the test · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 6- Doctor ordering HIV test at a lab near home to take the test · Very inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give the injection · Very convenient
|
2 Participants
|
3 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give the injection · Somewhat convenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give the injection · Neither convenient nor inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give the injection · Somewhat inconvenient
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used
Month 12- A nurse coming home to give the injection · Very inconvenient
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked if they would recommend telehealth services for APRETUDE to other people. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=41 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Neither agree not disagree
|
3 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Completely disagree
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Missing
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Completely agree
|
12 Participants
|
29 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Agree
|
9 Participants
|
9 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Disagree
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Completely disagree
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 6 - I would recommend telehealth services for APRETUDE to other people. · Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Completely agree
|
20 Participants
|
20 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Agree
|
2 Participants
|
7 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Neither agree not disagree
|
3 Participants
|
2 Participants
|
|
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery
Month 12 - I would recommend telehealth services for APRETUDE to other people. · Disagree
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The FIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services seems easy in my life) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.
Outcome measures
| Measure |
RI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=37 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs
Month 6 compared to BL
|
0.25 Scores on a scale
Standard Deviation 1.23
|
0.08 Scores on a scale
Standard Deviation 0.65
|
|
Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs
Month 12 compared to BL
|
0.17 Scores on a scale
Standard Deviation 1.21
|
-0.35 Scores on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.
Outcome measures
| Measure |
RI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=37 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs
Month 6 compared to BL
|
0.26 Scores on a scale
Standard Deviation 1.26
|
0.09 Scores on a scale
Standard Deviation 0.64
|
|
Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs
Month 12 compared to BL
|
0.21 Scores on a scale
Standard Deviation 1.11
|
-0.39 Scores on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to Baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.
Outcome measures
| Measure |
RI - SSP
n=65 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=94 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M6-Have you used telehealth for any APRETUDE services in the last 6 months? - YES
|
-45.8 Percentage of participants
|
-40.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M6-Have you used telehealth for any APRETUDE services in the last 6 months? - NO
|
35.1 Percentage of participants
|
35.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M6-Have you used telehealth for any APRETUDE services in the last 6 months?-DON'T KNOW
|
10.8 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M12 - Have you used telehealth for any APRETUDE services in the last 6 months? - YES
|
-43.1 Percentage of participants
|
-46.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M12 - Have you used telehealth for any APRETUDE services in the last 6 months? - NO
|
43.1 Percentage of participants
|
44.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery
Change BL to M12-Have you used telehealth for any APRETUDE services in the last 6 months?-DON'T KNOW
|
0.0 Percentage of participants
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points.
Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked their perceptions of these facilitators and barriers for telehealth services used. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=8 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=27 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · Very easy
|
4 Participants
|
12 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · Neither easy nor difficult
|
1 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · Neither easy nor difficult
|
1 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · Very easy
|
7 Participants
|
13 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · Somewhat easy
|
0 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · Neither easy nor difficult
|
0 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · Neither easy nor difficult
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · I don't use this system
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · Very easy
|
1 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · Somewhat easy
|
1 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · Very Difficult
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · Neither easy nor difficult
|
1 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · I don't use this system
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · Very easy
|
4 Participants
|
9 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · Somewhat easy
|
1 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · Neither easy nor difficult
|
0 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Automated phone call reminders · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · Very easy
|
7 Participants
|
9 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · Somewhat easy
|
1 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · Neither easy nor difficult
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · Somewhat easy
|
2 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Video consultation · I don't use this system
|
1 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · Very easy
|
2 Participants
|
14 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · Somewhat easy
|
2 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · Neither easy nor difficult
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · Somewhat Difficult
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telephone consultation · I don't use this system
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · Very easy
|
1 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · Somewhat easy
|
0 Participants
|
5 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Remote monitoring of patients · I don't use this system
|
1 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · Very easy
|
3 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · Somewhat easy
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · Neither easy nor difficult
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online appointment scheduling · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · Somewhat Difficult
|
1 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Patient portal conversations: ability for patients to send messages to providers · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · Very easy
|
1 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
At-home testing services · Somewhat easy
|
1 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Staff phone call reminder · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · Very easy
|
1 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · Somewhat easy
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · Neither easy nor difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending motivational reminders to help patients persist on APRETUDE · I don't use this system
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · Very easy
|
1 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · Somewhat easy
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · Neither easy nor difficult
|
1 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Sending cabotegravir oral lead in to patient's home · I don't use this system
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · Very easy
|
5 Participants
|
10 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · Somewhat easy
|
1 Participants
|
7 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · Neither easy nor difficult
|
1 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Insurance/benefits verification · Somewhat Difficult
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · Neither easy nor difficult
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Send and receiving patient reported outcomes questionnaires via an online system · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · Very easy
|
6 Participants
|
14 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · Somewhat easy
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · Neither easy nor difficult
|
0 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online prescription refills · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · Very easy
|
6 Participants
|
12 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · Somewhat easy
|
0 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · Neither easy nor difficult
|
0 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal for patients to access medical documents, such as visit summaries and test results · I don't use this system
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · Very easy
|
4 Participants
|
7 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · Somewhat easy
|
1 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · Neither easy nor difficult
|
1 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text messaging with patients about care · I don't use this system
|
0 Participants
|
1 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · Very easy
|
3 Participants
|
10 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · Somewhat easy
|
1 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · Neither easy nor difficult
|
0 Participants
|
2 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · Somewhat Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · Very Difficult
|
0 Participants
|
0 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Email reminders to patient about upcoming visits · I don't use this system
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · Very easy
|
6 Participants
|
12 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Text reminders · Somewhat easy
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. The use and adoption of some telehealth services were only assessed among DI PSPs. Only those participants with data available for the specified analysis at the specified time points were included.
Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked their perceptions of these facilitators and barriers for telehealth services used. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Screenings and assessments Used
|
0 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth Used for any service
|
5 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth Used for APRETUDE
|
5 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth used for things OTHER than APRETUDE, only
|
0 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth Not Used
|
12 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Not Asked About Telehealth
|
4 Participants
|
18 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth used/not used- Missing
|
0 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Telehealth DI Used
|
0 Participants
|
5 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Teleconsultant Used
|
0 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online Appointment Scheduler Used
|
0 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Reminders Used
|
0 Participants
|
3 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Home tests Used
|
0 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Local labs Used
|
0 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Online portal Used
|
0 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery
Home health nurses Used
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 4 and Month 12Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (1. APRETUDE in our clinic/practice meets my approval 2. APRETUDE in our clinic/practice is appealing to me 3. I like APRETUDE in our clinic/practice 4. I welcome APRETUDE in our clinic/practice), and AIM-Implementation (IMP) that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability. Timeframe for evaluation is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean AIM Score Assessed for SSPs
AIM-INT (Baseline)
|
4.66 Scores on a scale
Standard Deviation 0.48
|
4.69 Scores on a scale
Standard Deviation 0.43
|
|
Mean AIM Score Assessed for SSPs
AIM-INT (Month 4)
|
4.43 Scores on a scale
Standard Deviation 0.56
|
4.33 Scores on a scale
Standard Deviation 0.68
|
|
Mean AIM Score Assessed for SSPs
AIM-INT (Month 12)
|
4.52 Scores on a scale
Standard Deviation 0.56
|
4.41 Scores on a scale
Standard Deviation 0.57
|
|
Mean AIM Score Assessed for SSPs
AIM-IMP (Baseline)
|
4.05 Scores on a scale
Standard Deviation 0.76
|
3.97 Scores on a scale
Standard Deviation 0.83
|
|
Mean AIM Score Assessed for SSPs
AIM-IMP (Month 4)
|
3.86 Scores on a scale
Standard Deviation 0.84
|
3.92 Scores on a scale
Standard Deviation 0.80
|
|
Mean AIM Score Assessed for SSPs
AIM-IMP (Month 12)
|
3.90 Scores on a scale
Standard Deviation 1.08
|
4.09 Scores on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 4 and Month 12Population: Analysis was performed on all SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of rescheduling appointments during correct injection windows · Extremely concerned
|
2 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of rescheduling appointments during correct injection windows · Moderately concerned
|
1 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of rescheduling appointments during correct injection windows · Somewhat concerned
|
2 Participants
|
8 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to identify and flag missed injection visits to providers (in a timely manner) · Extremely concerned
|
3 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to manage patients presenting to APRETUDE appointments with other care needs · Not at all concerned
|
17 Participants
|
29 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of scheduling injection appointments during correct injection windows · Somewhat concerned
|
2 Participants
|
13 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of scheduling injection appointments during correct injection windows · Slightly concerned
|
7 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of scheduling injection appointments during correct injection windows · Extremely concerned
|
2 Participants
|
3 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of scheduling injection appointments during correct injection windows · Moderately concerned
|
4 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of scheduling injection appointments during correct injection windows · Not at all concerned
|
15 Participants
|
30 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of rescheduling appointments during correct injection windows · Moderately concerned
|
6 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of rescheduling appointments during correct injection windows · Somewhat concerned
|
3 Participants
|
15 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of rescheduling appointments during correct injection windows · Slightly concerned
|
9 Participants
|
6 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Management of rescheduling appointments during correct injection windows · Not at all concerned
|
10 Participants
|
27 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to schedule/reschedule patients who missed APRETUDE visits · Extremely concerned
|
3 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to schedule/reschedule patients who missed APRETUDE visits · Moderately concerned
|
4 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to schedule/reschedule patients who missed APRETUDE visits · Somewhat concerned
|
5 Participants
|
16 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to schedule/reschedule patients who missed APRETUDE visits · Slightly concerned
|
9 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to schedule/reschedule patients who missed APRETUDE visits · Not at all concerned
|
9 Participants
|
27 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to identify and flag missed injection visits to providers (in a timely manner) · Extremely concerned
|
5 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to identify and flag missed injection visits to providers (in a timely manner) · Moderately concerned
|
5 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to identify and flag missed injection visits to providers (in a timely manner) · Somewhat concerned
|
4 Participants
|
15 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to identify and flag missed injection visits to providers (in a timely manner) · Slightly concerned
|
4 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to identify and flag missed injection visits to providers (in a timely manner) · Not at all concerned
|
12 Participants
|
26 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to manage patients presenting to APRETUDE appointments with other care needs · Extremely concerned
|
3 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to manage patients presenting to APRETUDE appointments with other care needs · Moderately concerned
|
4 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to manage patients presenting to APRETUDE appointments with other care needs · Somewhat concerned
|
4 Participants
|
11 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to manage patients presenting to APRETUDE appointments with other care needs · Slightly concerned
|
5 Participants
|
9 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Baseline- Ability to manage patients presenting to APRETUDE appointments with other care needs · Not at all concerned
|
14 Participants
|
27 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of scheduling injection appointments during correct injection windows · Extremely concerned
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of scheduling injection appointments during correct injection windows · Moderately concerned
|
0 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of scheduling injection appointments during correct injection windows · Somewhat concerned
|
2 Participants
|
6 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of scheduling injection appointments during correct injection windows · Slightly concerned
|
4 Participants
|
3 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of scheduling injection appointments during correct injection windows · Not at all concerned
|
21 Participants
|
35 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of rescheduling appointments during correct injection windows · Extremely concerned
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of rescheduling appointments during correct injection windows · Slightly concerned
|
9 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Management of rescheduling appointments during correct injection windows · Not at all concerned
|
15 Participants
|
32 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to schedule/reschedule patients who missed APRETUDE visits within injection windows · Extremely concerned
|
2 Participants
|
1 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to schedule/reschedule patients who missed APRETUDE visits within injection windows · Moderately concerned
|
1 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to schedule/reschedule patients who missed APRETUDE visits within injection windows · Somewhat concerned
|
1 Participants
|
11 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to schedule/reschedule patients who missed APRETUDE visits within injection windows · Slightly concerned
|
10 Participants
|
7 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to schedule/reschedule patients who missed APRETUDE visits within injection windows · Not at all concerned
|
15 Participants
|
27 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to identify and flag missed injection visits to providers (in a timely manner) · Extremely concerned
|
2 Participants
|
3 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to identify and flag missed injection visits to providers (in a timely manner) · Moderately concerned
|
2 Participants
|
7 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to identify and flag missed injection visits to providers (in a timely manner) · Somewhat concerned
|
2 Participants
|
10 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to identify and flag missed injection visits to providers (in a timely manner) · Slightly concerned
|
7 Participants
|
6 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to identify and flag missed injection visits to providers (in a timely manner) · Not at all concerned
|
16 Participants
|
25 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to manage patients presenting to APRETUDE appointments with other care needs · Extremely concerned
|
3 Participants
|
1 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to manage patients presenting to APRETUDE appointments with other care needs · Moderately concerned
|
2 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to manage patients presenting to APRETUDE appointments with other care needs · Somewhat concerned
|
1 Participants
|
15 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to manage patients presenting to APRETUDE appointments with other care needs · Slightly concerned
|
3 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 4- Ability to manage patients presenting to APRETUDE appointments with other care needs · Not at all concerned
|
20 Participants
|
25 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of scheduling injection appointments every 2 months during injection windows · Extremely concerned
|
1 Participants
|
0 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of scheduling injection appointments every 2 months during injection windows · Moderately concerned
|
2 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of scheduling injection appointments every 2 months during injection windows · Somewhat concerned
|
2 Participants
|
5 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of scheduling injection appointments every 2 months during injection windows · Slightly concerned
|
4 Participants
|
7 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of scheduling injection appointments every 2 months during injection windows · Not at all concerned
|
20 Participants
|
36 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of rescheduling appointments during correct injection windows · Extremely concerned
|
1 Participants
|
1 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of rescheduling appointments during correct injection windows · Moderately concerned
|
3 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of rescheduling appointments during correct injection windows · Somewhat concerned
|
1 Participants
|
8 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of rescheduling appointments during correct injection windows · Slightly concerned
|
7 Participants
|
10 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Management of rescheduling appointments during correct injection windows · Not at all concerned
|
17 Participants
|
29 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to schedule/reschedule patients who missed APRETUDE visits · Extremely concerned
|
1 Participants
|
2 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to schedule/reschedule patients who missed APRETUDE visits · Moderately concerned
|
2 Participants
|
3 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to schedule/reschedule patients who missed APRETUDE visits · Somewhat concerned
|
3 Participants
|
8 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to schedule/reschedule patients who missed APRETUDE visits · Slightly concerned
|
9 Participants
|
11 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to schedule/reschedule patients who missed APRETUDE visits · Not at all concerned
|
14 Participants
|
28 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to identify and flag missed injection visits to providers (in a timely manner) · Moderately concerned
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to identify and flag missed injection visits to providers (in a timely manner) · Somewhat concerned
|
5 Participants
|
8 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to identify and flag missed injection visits to providers (in a timely manner) · Slightly concerned
|
9 Participants
|
10 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to identify and flag missed injection visits to providers (in a timely manner) · Not at all concerned
|
12 Participants
|
26 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to manage patients presenting to APRETUDE appointments with other care needs · Extremely concerned
|
1 Participants
|
1 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to manage patients presenting to APRETUDE appointments with other care needs · Moderately concerned
|
3 Participants
|
3 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to manage patients presenting to APRETUDE appointments with other care needs · Somewhat concerned
|
2 Participants
|
10 Participants
|
|
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE
Month 12- Ability to manage patients presenting to APRETUDE appointments with other care needs · Slightly concerned
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: At Month 4 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on the SSPs who completed at least one survey at any time point. Only those participants with data available for the specified analysis at the specified time points were included.
AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (1. APRETUDE in our clinic/practice meets my approval 2. APRETUDE in our clinic/practice is appealing to me 3. I like APRETUDE in our clinic/practice 4. I welcome APRETUDE in our clinic/practice), and AIM-IMP that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability. Timeframe for evaluation is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to BL.
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=48 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in AIM Score Assessed for SSPs
AIM-IMP, Month 12 compared to BL
|
-0.20 Scores on a scale
Standard Deviation 1.24
|
0.04 Scores on a scale
Standard Deviation 0.84
|
|
Change From Baseline in AIM Score Assessed for SSPs
AIM-INT, Month 4 compared to BL
|
-0.22 Scores on a scale
Standard Deviation 0.67
|
-0.36 Scores on a scale
Standard Deviation 0.66
|
|
Change From Baseline in AIM Score Assessed for SSPs
AIM-INT, Month 12 compared to BL
|
-0.11 Scores on a scale
Standard Deviation 0.74
|
-0.33 Scores on a scale
Standard Deviation 0.50
|
|
Change From Baseline in AIM Score Assessed for SSPs
AIM-IMP, Month 4 compared to BL
|
-0.16 Scores on a scale
Standard Deviation 0.81
|
-0.06 Scores on a scale
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: At Month 4 and 12 compared to Baseline (Month 1)Population: Analysis was performed on all SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE (Item \[I\]1= Management of scheduling injection appointments during correct injection windows, I2= Management of rescheduling appointments during correct injection windows, I3= Ability to schedule/reschedule patients who missed APRETUDE visits, I4= Ability to identify and flag missed injection visits to providers (in a timely manner), I5= Ability to manage patients presenting to APRETUDE appointments with other care needs). Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=52 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I5: Extremely concerned
|
-6.6 Percentage of participants
|
-7.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I1: Extremely concerned
|
0.2 Percentage of participants
|
-1.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I1: Moderately concerned
|
-13.3 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I1: Somewhat concerned
|
0.2 Percentage of participants
|
-11.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I1: Slightly concerned
|
-9.5 Percentage of participants
|
-3.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I1: Not at all concerned
|
22.4 Percentage of participants
|
15.1 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I2: Extremely concerned
|
0.2 Percentage of participants
|
-3.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I2: Moderately concerned
|
-16.6 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I2: Somewhat concerned
|
-3.1 Percentage of participants
|
-11.1 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I2: Slightly concerned
|
1.0 Percentage of participants
|
-2.9 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I2: Not at all concerned
|
18.4 Percentage of participants
|
14.5 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I3: Extremely concerned
|
-3.1 Percentage of participants
|
-5.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I3: Moderately concerned
|
-9.9 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I3: Somewhat concerned
|
-13.2 Percentage of participants
|
-7.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I3: Slightly concerned
|
4.5 Percentage of participants
|
6.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I3: Not at all concerned
|
21.7 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I4: Extremely concerned
|
-9.8 Percentage of participants
|
-3.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I4: Moderately concerned
|
-9.8 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I4: Somewhat concerned
|
-6.4 Percentage of participants
|
-7.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I4: Slightly concerned
|
10.8 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I4: Not at all concerned
|
15.2 Percentage of participants
|
2.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I5: Extremely concerned
|
0.3 Percentage of participants
|
-7.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I5: Moderately concerned
|
-6.4 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I5: Somewhat concerned
|
-9.9 Percentage of participants
|
9.8 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I5: Slightly concerned
|
-6.3 Percentage of participants
|
-6.3 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M4 - I5: Not at all concerned
|
22.3 Percentage of participants
|
0.8 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I1: Extremely concerned
|
-3.2 Percentage of participants
|
-5.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I1: Moderately concerned
|
-6.4 Percentage of participants
|
-1.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I1: Somewhat concerned
|
0.2 Percentage of participants
|
-13.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I1: Slightly concerned
|
-9.5 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I1: Not at all concerned
|
19.0 Percentage of participants
|
15.7 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I2: Extremely concerned
|
-3.2 Percentage of participants
|
-5.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I2: Moderately concerned
|
-9.7 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I2: Somewhat concerned
|
-6.6 Percentage of participants
|
-11.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I2: Slightly concerned
|
-5.9 Percentage of participants
|
8.5 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I2: Not at all concerned
|
25.3 Percentage of participants
|
7.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I3: Extremely concerned
|
-6.6 Percentage of participants
|
-3.3 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I3: Moderately concerned
|
-6.4 Percentage of participants
|
-3.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I3: Somewhat concerned
|
-6.3 Percentage of participants
|
-13.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I3: Slightly concerned
|
1.0 Percentage of participants
|
14.0 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I3: Not at all concerned
|
18.3 Percentage of participants
|
5.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I4: Extremely concerned
|
-6.3 Percentage of participants
|
-1.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I4: Moderately concerned
|
-16.7 Percentage of participants
|
-1.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I4: Somewhat concerned
|
3.9 Percentage of participants
|
-11.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I4: Slightly concerned
|
17.7 Percentage of participants
|
10.3 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I4: Not at all concerned
|
1.4 Percentage of participants
|
3.6 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I5: Moderately concerned
|
-3.0 Percentage of participants
|
-1.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I5: Somewhat concerned
|
-6.4 Percentage of participants
|
-0.4 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I5: Slightly concerned
|
4.0 Percentage of participants
|
1.2 Percentage of participants
|
|
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE
Change BL to M12 - I5: Not at all concerned
|
12.0 Percentage of participants
|
7.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At Baseline (Month 1), Month 6 and Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=77 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=105 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Mean AIM Score Assessed for PSPs
Month 12
|
4.60 Scores on a scale
Standard Deviation 0.67
|
4.61 Scores on a scale
Standard Deviation 0.63
|
|
Mean AIM Score Assessed for PSPs
Baseline
|
4.41 Scores on a scale
Standard Deviation 0.68
|
4.46 Scores on a scale
Standard Deviation 0.69
|
|
Mean AIM Score Assessed for PSPs
Month 6
|
4.57 Scores on a scale
Standard Deviation 0.55
|
4.57 Scores on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: At Baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE.
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Helpful
|
25 Participants
|
27 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Missing
|
0 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Missing
|
9 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Somewhat helpful
|
10 Participants
|
11 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Very helpful
|
0 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · A little helpful
|
3 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Did not use it
|
7 Participants
|
24 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Missing
|
9 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Missing
|
0 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Somewhat helpful
|
0 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Did not use it
|
0 Participants
|
38 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Very helpful
|
32 Participants
|
35 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Helpful
|
23 Participants
|
27 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Somewhat helpful
|
10 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · A little helpful
|
2 Participants
|
7 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Not at all helpful
|
2 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Did not use it
|
6 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Missing
|
9 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Patient Brochure that helps understand the process of receiving APRETUDE injections · Very helpful
|
30 Participants
|
37 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Very helpful
|
0 Participants
|
32 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Helpful
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Somewhat helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · A little helpful
|
0 Participants
|
7 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
Let's talk about HIV & PrEP video that gives key facts about HIV and PrEP options (DI) · Did not use it
|
0 Participants
|
32 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Very helpful
|
0 Participants
|
30 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Somewhat helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · A little helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Did not use it
|
0 Participants
|
38 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Missing
|
0 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Very helpful
|
0 Participants
|
30 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Helpful
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Somewhat helpful
|
0 Participants
|
7 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · A little helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Very helpful
|
0 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Helpful
|
0 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Somewhat helpful
|
0 Participants
|
9 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · A little helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Did not use it
|
0 Participants
|
41 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Missing
|
0 Participants
|
12 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Very helpful
|
28 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Helpful
|
19 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Somewhat helpful
|
13 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · A little helpful
|
4 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study website to access APRETDUE information (RI) · Did not use it
|
11 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · A little helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Did not use it
|
0 Participants
|
42 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline
The study app to access APRETUDE information (DI) · Missing
|
0 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: At Month 6Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE. Timeframe for evaluation of this outcome measure is M6 (equivalent to M7 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Somewhat helpful
|
0 Participants
|
10 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Not at all helpful
|
1 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Did not receive/Did not use it
|
16 Participants
|
28 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Not at all helpful
|
0 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Missing
|
21 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Very helpful
|
0 Participants
|
24 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Helpful
|
0 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Very helpful
|
21 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Helpful
|
16 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Somewhat helpful
|
8 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · A little helpful
|
2 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Not at all helpful
|
1 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study website to access APRETDUE information (RI) · Did not receive/Did not use it
|
15 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Somewhat helpful
|
0 Participants
|
15 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · A little helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Not at all helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Did not receive/Did not use it
|
0 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The study app to access APRETUDE information (DI) · Missing
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Very helpful
|
19 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Helpful
|
18 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Somewhat helpful
|
9 Participants
|
11 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · A little helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Very helpful
|
24 Participants
|
28 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Helpful
|
17 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Helpful
|
0 Participants
|
16 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Somewhat helpful
|
6 Participants
|
18 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · A little helpful
|
0 Participants
|
3 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Did not receive/Did not use it
|
16 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Very helpful
|
21 Participants
|
29 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Helpful
|
18 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Somewhat helpful
|
7 Participants
|
14 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · A little helpful
|
1 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Did not receive/Did not use it
|
16 Participants
|
29 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Patient Brochure helps understand the process of receiving APRETUDE injections · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Very helpful
|
0 Participants
|
27 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Helpful
|
0 Participants
|
19 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Somewhat helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · A little helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Did not receive/Did not use it
|
0 Participants
|
32 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Missing
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Very helpful
|
0 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Helpful
|
0 Participants
|
20 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Somewhat helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · A little helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Not at all helpful
|
0 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Did not receive/Did not use it
|
0 Participants
|
34 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Missing
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Very helpful
|
0 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Helpful
|
0 Participants
|
16 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Somewhat helpful
|
0 Participants
|
9 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · A little helpful
|
0 Participants
|
4 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Did not receive/Did not use it
|
0 Participants
|
36 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Missing
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Very helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Helpful
|
0 Participants
|
15 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · A little helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Did not receive/Did not use it
|
0 Participants
|
38 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Missing
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important safety information document details safety information relating to APRETUDE · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Very helpful
|
19 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Helpful
|
17 Participants
|
19 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Somewhat helpful
|
9 Participants
|
10 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · A little helpful
|
1 Participants
|
4 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Not at all helpful
|
1 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Did not receive/Did not use it
|
16 Participants
|
32 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
Important facts document details important facts relating to APRETUDE · Missing
|
21 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Very helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Somewhat helpful
|
0 Participants
|
9 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · A little helpful
|
0 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Did not receive/Did not use it
|
0 Participants
|
41 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6
A flyer on PrEP options (DI) · Missing
|
0 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: At Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Somewhat helpful
|
10 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · A little helpful
|
3 Participants
|
4 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Not at all helpful
|
1 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Helpful
|
0 Participants
|
20 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Missing
|
0 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Missing
|
0 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Very helpful
|
0 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Helpful
|
0 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Somewhat helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · A little helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Did not receive/Did not use it
|
0 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Very helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Somewhat helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · A little helpful
|
0 Participants
|
3 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Somewhat helpful
|
7 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · A little helpful
|
7 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Missing
|
21 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Very helpful
|
0 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Helpful
|
0 Participants
|
19 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Somewhat helpful
|
0 Participants
|
9 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Not at all helpful
|
0 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Did not receive/Did not use it
|
0 Participants
|
18 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · Missing
|
0 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Very helpful
|
19 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · A little helpful
|
5 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Not at all helpful
|
1 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Did not receive/Did not use it
|
12 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Helpful
|
16 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · A little helpful
|
6 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Not at all helpful
|
1 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Did not receive/Did not use it
|
13 Participants
|
24 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Helpful
|
14 Participants
|
17 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Somewhat helpful
|
7 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · A little helpful
|
5 Participants
|
2 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Not at all helpful
|
1 Participants
|
1 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Did not receive/Did not use it
|
17 Participants
|
27 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Did not receive/Did not use it
|
0 Participants
|
24 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Missing
|
0 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Very helpful
|
19 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Helpful
|
16 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Not at all helpful
|
1 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study website to access APRETDUE information (RI) · Did not receive/Did not use it
|
13 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The study app/website to access APRETUDE information - the Pillar Spot (DI) · A little helpful
|
0 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Helpful
|
17 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Somewhat helpful
|
9 Participants
|
9 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important safety information document details safety information relating to APRETUDE · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Very helpful
|
20 Participants
|
21 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Very helpful
|
24 Participants
|
23 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Helpful
|
14 Participants
|
26 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Somewhat helpful
|
8 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · A little helpful
|
2 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Not at all helpful
|
2 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Did not receive/Did not use it
|
13 Participants
|
18 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Getting Started Brochure that gives an overview of how to get started with APRETUDE · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Very helpful
|
22 Participants
|
22 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Helpful
|
14 Participants
|
27 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Patient Brochure helps understand the process of receiving APRETUDE injections · Did not receive/Did not use it
|
13 Participants
|
18 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Very helpful
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Somewhat helpful
|
0 Participants
|
6 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · A little helpful
|
0 Participants
|
5 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Let's talk about HIV & PrEP video gives key facts about HIV and PrEP options (DI) · Did not receive/Did not use it
|
0 Participants
|
21 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Very helpful
|
0 Participants
|
25 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Helpful
|
0 Participants
|
18 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Somewhat helpful
|
0 Participants
|
7 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · A little helpful
|
0 Participants
|
3 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Not at all helpful
|
0 Participants
|
0 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The APRETUDE Myths and Facts video, the game show video addressing common myths about APRETUDE (DI) · Did not receive/Did not use it
|
0 Participants
|
24 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The What to Expect video which shows what to expect during the APRETUDE process (DI) · Missing
|
0 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
The ViiV Connect Video tells about the ViiV Connect program and frequently asked questions (DI) · Helpful
|
0 Participants
|
20 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Somewhat helpful
|
7 Participants
|
8 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
Important facts document details important facts relating to APRETUDE · Missing
|
21 Participants
|
40 Participants
|
|
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12
A flyer on PrEP options · Very helpful
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who successfully completed a portion of the survey. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each with a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Change From Baseline in Mean AIM Score in PSPs
Month 6 compared to BL
|
0.20 Scores on a scale
Standard Deviation 0.72
|
0.17 Scores on a scale
Standard Deviation 0.66
|
|
Change From Baseline in Mean AIM Score in PSPs
Month 12 compared to BL
|
0.19 Scores on a scale
Standard Deviation 0.87
|
0.27 Scores on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: At Month 6 and Month 12 compared to Baseline (Month 1)Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. All questions were not administered to both RI and DI arms; hence, certain Rows have 0 participants analyzed within each Arm/Group.
In this outcome measure, usong the ISQ, PSPs were asked about the helpfulness of various knowledge materials (I1= Getting Started Brochure that gives an overview of how to get started with APRETUDE, I2 = Patient Brochure helps understand the process of receiving APRETUDE, I3 = HIV \& PrEP video gives key facts about HIV and PrEP options (DI), I4 = APRETUDE Myths and Facts video, addressing common myths about APRETUDE (DI), I5 = The What to Expect video which shows what to expect during the APRETUDE process (DI), I6 = The ViiV Connect program Video and frequently asked questions (DI), I7 = The study website to access APRETDUE information (RI), I8 = The study app to access APRETUDE information (DI). Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.
Outcome measures
| Measure |
RI - SSP
n=63 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=92 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: Very helpful
|
-4.6 Percentage of participants
|
-2.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: Helpful
|
-3.7 Percentage of participants
|
-7.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: Somewhat helpful
|
-3.8 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: A little helpful
|
-2.7 Percentage of participants
|
-3.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: Not at all helpful
|
-2.7 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I1: I did not use it
|
17.4 Percentage of participants
|
5.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: Very helpful
|
-6.7 Percentage of participants
|
-3.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: Helpful
|
-4.8 Percentage of participants
|
-7.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: Somewhat helpful
|
-2.2 Percentage of participants
|
4.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: A little helpful
|
-2.4 Percentage of participants
|
-2.6 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: I did not use it
|
16.1 Percentage of participants
|
8.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: Very helpful
|
—
|
-1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: A little helpful
|
—
|
-1.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: Not at all helpful
|
—
|
0.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: Helpful
|
—
|
0.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: Somewhat helpful
|
—
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: Not at all helpful
|
—
|
1.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: Helpful
|
—
|
-5.6 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: A little helpful
|
—
|
0.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: Not at all helpful
|
—
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: I did not use it
|
—
|
2.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: Helpful
|
0.1 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: Somewhat helpful
|
-4.6 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: Not at all helpful
|
1.6 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: Not at all helpful
|
—
|
5.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: I did not use it
|
—
|
-15.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: Very helpful
|
-4.6 Percentage of participants
|
-3.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: Helpful
|
-8.4 Percentage of participants
|
8.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: Somewhat helpful
|
-0.6 Percentage of participants
|
-4.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: Not at all helpful
|
0.5 Percentage of participants
|
-1.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: I did not use it
|
12.6 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: Very helpful
|
-5.1 Percentage of participants
|
-6.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: Helpful
|
-11.1 Percentage of participants
|
9.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: Somewhat helpful
|
2.5 Percentage of participants
|
-2.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: A little helpful
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: Very helpful
|
—
|
2.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: Helpful
|
—
|
2.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: Somewhat helpful
|
—
|
0.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: A little helpful
|
—
|
-0.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: Not at all helpful
|
—
|
-1.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: Very helpful
|
—
|
3.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: Helpful
|
—
|
2.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: Somewhat helpful
|
—
|
1.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: A little helpful
|
—
|
-1.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: Not at all helpful
|
—
|
-1.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I4: I did not use it
|
—
|
-5.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: Very helpful
|
—
|
5.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: Somewhat helpful
|
—
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: A little helpful
|
—
|
1.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: Not at all helpful
|
—
|
0.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: I did not use it
|
—
|
-6.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: Very helpful
|
—
|
3.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: Helpful
|
—
|
4.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: Somewhat helpful
|
—
|
1.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: A little helpful
|
—
|
-1.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: Not at all helpful
|
—
|
0.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I6: I did not use it
|
—
|
-7.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: Very helpful
|
-7.2 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: Helpful
|
0.1 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: Somewhat helpful
|
-6.2 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: Not at all helpful
|
1.6 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: I did not use it
|
6.0 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: Very helpful
|
—
|
6.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: Helpful
|
—
|
3.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: Somewhat helpful
|
—
|
0.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: A little helpful
|
—
|
4.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: Not at all helpful
|
—
|
1.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I8: I did not use it
|
—
|
-16.6 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I1: A little helpful
|
0.5 Percentage of participants
|
-0.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I2: Not at all helpful
|
0.0 Percentage of participants
|
0.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: Helpful
|
—
|
-3.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: Somewhat helpful
|
—
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I3: I did not use it
|
—
|
4.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: Very helpful
|
—
|
-3.6 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: A little helpful
|
—
|
-0.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I4: I did not use it
|
—
|
0.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: Very helpful
|
—
|
-0.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: Helpful
|
—
|
-6.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: Somewhat helpful
|
—
|
3.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: A little helpful
|
—
|
-0.4 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: Not at all helpful
|
—
|
1.1 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I5: I did not use it
|
—
|
2.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: Very helpful
|
—
|
-0.8 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I6: Somewhat helpful
|
—
|
2.3 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: Very helpful
|
-4.0 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: A little helpful
|
-2.2 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I7: I did not use it
|
9.1 Percentage of participants
|
—
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: Very helpful
|
—
|
4.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: Helpful
|
—
|
-2.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: Somewhat helpful
|
—
|
4.9 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M6 - I8: A little helpful
|
—
|
3.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: Not at all helpful
|
1.6 Percentage of participants
|
-1.0 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I2: I did not use it
|
11.3 Percentage of participants
|
0.5 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I3: I did not use it
|
—
|
-3.2 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I5: Helpful
|
—
|
-1.7 Percentage of participants
|
|
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy
Change BL to M12 - I7: A little helpful
|
5.8 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the usefulness of various implementation strategies used for implementing APRETUDE in their clinic/practice. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=29 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=52 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Frequently Asked Questions Brochure · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Frequently Asked Questions Brochure · A little useful
|
1 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Frequently Asked Questions Brochure · Somewhat useful
|
1 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Frequently Asked Questions Brochure · Useful
|
8 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Frequently Asked Questions Brochure · Very Useful
|
2 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Readiness Consideration · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Readiness Consideration · A little useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Readiness Consideration · Somewhat useful
|
2 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Readiness Consideration · Useful
|
7 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Readiness Consideration · Very Useful
|
2 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Get Started Overview-Init/Adm Guide · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Get Started Overview-Init/Adm Guide · A little useful
|
0 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Get Started Overview-Init/Adm Guide · Somewhat useful
|
2 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Get Started Overview-Init/Adm Guide · Useful
|
7 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Get Started Overview-Init/Adm Guide · Very Useful
|
2 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Injection Education Video · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Injection Education Video · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Injection Education Video · Somewhat useful
|
5 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Injection Education Video · Useful
|
7 Participants
|
8 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Provider Website- location where all materials and videos on APRETUDE are located (RI) · Not at all useful
|
2 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Provider Website- location where all materials and videos on APRETUDE are located (RI) · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Provider Website- location where all materials and videos on APRETUDE are located (RI) · Somewhat useful
|
2 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Provider Website- location where all materials and videos on APRETUDE are located (RI) · Useful
|
8 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Provider Website- location where all materials and videos on APRETUDE are located (RI) · Very Useful
|
1 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Patient Materials · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Patient Materials · A little useful
|
0 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Patient Materials · Somewhat useful
|
2 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Patient Materials · Useful
|
10 Participants
|
7 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Patient Materials · Very Useful
|
3 Participants
|
8 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Implementation Guidance Video (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Implementation Guidance Video (DI) · A little useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Implementation Guidance Video (DI) · Somewhat useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Implementation Guidance Video (DI) · Useful
|
0 Participants
|
9 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Implementation Guidance Video (DI) · Very Useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Appointment Scheduler · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Appointment Scheduler · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Appointment Scheduler · Somewhat useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Appointment Scheduler · Useful
|
5 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Appointment Scheduler · Very Useful
|
2 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Pre-scheduled Appointment Guidance (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Pre-scheduled Appointment Guidance (DI) · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Pre-scheduled Appointment Guidance (DI) · Somewhat useful
|
0 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Pre-scheduled Appointment Guidance (DI) · Useful
|
0 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Pre-scheduled Appointment Guidance (DI) · Very Useful
|
0 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Designated Injection Days Guidance (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Designated Injection Days Guidance (DI) · A little useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Designated Injection Days Guidance (DI) · Somewhat useful
|
0 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Designated Injection Days Guidance (DI) · Useful
|
0 Participants
|
7 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Designated Injection Days Guidance (DI) · Very Useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Drop-in Injection Visits Guidance (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Drop-in Injection Visits Guidance (DI) · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Drop-in Injection Visits Guidance (DI) · Somewhat useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Drop-in Injection Visits Guidance (DI) · Useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Drop-in Injection Visits Guidance (DI) · Very Useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Transport Support to Patient Appt (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Transport Support to Patient Appt (DI) · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Transport Support to Patient Appt (DI) · Somewhat useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Transport Support to Patient Appt (DI) · Useful
|
0 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Transport Support to Patient Appt (DI) · Very Useful
|
0 Participants
|
11 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Monthly Implement Facilitation Call (DI) · Not at all useful
|
0 Participants
|
2 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Monthly Implement Facilitation Call (DI) · A little useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Monthly Implement Facilitation Call (DI) · Somewhat useful
|
0 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Monthly Implement Facilitation Call (DI) · Useful
|
0 Participants
|
9 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Monthly Implement Facilitation Call (DI) · Very Useful
|
0 Participants
|
8 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Group Implement Facilitation Calls (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Group Implement Facilitation Calls (DI) · A little useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Group Implement Facilitation Calls (DI) · Somewhat useful
|
0 Participants
|
5 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Group Implement Facilitation Calls (DI) · Useful
|
0 Participants
|
8 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Group Implement Facilitation Calls (DI) · Very Useful
|
0 Participants
|
9 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Document on How Discuss Sex Health (DI) · Not at all useful
|
0 Participants
|
0 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Document on How Discuss Sex Health (DI) · A little useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Document on How Discuss Sex Health (DI) · Somewhat useful
|
0 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Document on How Discuss Sex Health (DI) · Useful
|
0 Participants
|
6 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Document on How Discuss Sex Health (DI) · Very Useful
|
0 Participants
|
4 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
PILLAR Spot (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
PILLAR Spot (DI) · A little useful
|
0 Participants
|
3 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
PILLAR Spot (DI) · Somewhat useful
|
0 Participants
|
7 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
PILLAR Spot (DI) · Useful
|
0 Participants
|
13 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
PILLAR Spot (DI) · Very Useful
|
0 Participants
|
10 Participants
|
|
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Injection Education Video · Very Useful
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how useful various implementation strategies have been in supporting them while taking APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Brochures and other print materials to educate you on APRETUDE · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Brochures and other print materials to educate you on APRETUDE · Not very useful
|
1 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Brochures and other print materials to educate you on APRETUDE · Somewhat useful
|
10 Participants
|
10 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Brochures and other print materials to educate you on APRETUDE · Useful
|
12 Participants
|
23 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Brochures and other print materials to educate you on APRETUDE · Extremely useful
|
12 Participants
|
13 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Videos to educate you on HIV, PrEP, APRETUDE materials (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Videos to educate you on HIV, PrEP, APRETUDE materials (DI) · Not very useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Videos to educate you on HIV, PrEP, APRETUDE materials (DI) · Somewhat useful
|
0 Participants
|
8 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Videos to educate you on HIV, PrEP, APRETUDE materials (DI) · Useful
|
0 Participants
|
21 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Videos to educate you on HIV, PrEP, APRETUDE materials (DI) · Extremely useful
|
0 Participants
|
9 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A digital calendar specifically made for APRETUDE to help plan injections, found on Pillar Spot (DI) · Not at all useful
|
0 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A digital calendar specifically made for APRETUDE to help plan injections, found on Pillar Spot (DI) · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A digital calendar specifically made for APRETUDE to help plan injections, found on Pillar Spot (DI) · Somewhat useful
|
0 Participants
|
3 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Reminders about injections · Somewhat useful
|
3 Participants
|
5 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Reminders about injections · Useful
|
22 Participants
|
25 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Reminders about injections · Extremely useful
|
26 Participants
|
30 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having video or telephone appointments with your doctor · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having video or telephone appointments with your doctor · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having video or telephone appointments with your doctor · Somewhat useful
|
1 Participants
|
3 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having video or telephone appointments with your doctor · Useful
|
7 Participants
|
7 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having video or telephone appointments with your doctor · Extremely useful
|
8 Participants
|
6 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Sending chats or texts to your doctor on the Pillar Spot (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Sending chats or texts to your doctor on the Pillar Spot (DI) · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Sending chats or texts to your doctor on the Pillar Spot (DI) · Somewhat useful
|
0 Participants
|
3 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Sending chats or texts to your doctor on the Pillar Spot (DI) · Useful
|
0 Participants
|
11 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Sending chats or texts to your doctor on the Pillar Spot (DI) · Extremely useful
|
0 Participants
|
8 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to conduct your HIV test (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to conduct your HIV test (DI) · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to conduct your HIV test (DI) · Somewhat useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to conduct your HIV test (DI) · Useful
|
0 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to conduct your HIV test (DI) · Extremely useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to give your injection (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to give your injection (DI) · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to give your injection (DI) · Somewhat useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to give your injection (DI) · Useful
|
0 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Having a nurse come home to give your injection (DI) · Extremely useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Receiving transportation to the clinic/doctor's office for your injection (DI) · Not at all useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Receiving transportation to the clinic/doctor's office for your injection (DI) · Not very useful
|
0 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Receiving transportation to the clinic/doctor's office for your injection (DI) · Somewhat useful
|
0 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Receiving transportation to the clinic/doctor's office for your injection (DI) · Useful
|
0 Participants
|
4 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Receiving transportation to the clinic/doctor's office for your injection (DI) · Extremely useful
|
0 Participants
|
15 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A website/app to access APRETUDE information- the Pillar Spot (DI) · Not at all useful
|
0 Participants
|
2 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A website/app to access APRETUDE information- the Pillar Spot (DI) · Not very useful
|
0 Participants
|
1 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A website/app to access APRETUDE information- the Pillar Spot (DI) · Somewhat useful
|
0 Participants
|
8 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A website/app to access APRETUDE information- the Pillar Spot (DI) · Useful
|
0 Participants
|
14 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A website/app to access APRETUDE information- the Pillar Spot (DI) · Extremely useful
|
0 Participants
|
7 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
The website to access APRETUDE information (RI) · Not at all useful
|
1 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
The website to access APRETUDE information (RI) · Not very useful
|
1 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
The website to access APRETUDE information (RI) · Somewhat useful
|
6 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
The website to access APRETUDE information (RI) · Useful
|
11 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
The website to access APRETUDE information (RI) · Extremely useful
|
6 Participants
|
0 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A digital calendar specifically made for APRETUDE to help plan injections, found on Pillar Spot (DI) · Useful
|
0 Participants
|
6 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
A digital calendar specifically made for APRETUDE to help plan injections, found on Pillar Spot (DI) · Extremely useful
|
0 Participants
|
4 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Reminders about injections · Not at all useful
|
0 Participants
|
3 Participants
|
|
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use
Reminders about injections · Not very useful
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs provided their insights on the tools and strategies used for implementing APRETUDE during the PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=16 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Medication Administration Planner
|
4 Participants
|
7 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Getting Started Overview
|
11 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Injection Education Video
|
10 Participants
|
13 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Drop-in visits (DI)
|
0 Participants
|
11 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Designated injection days (DI)
|
0 Participants
|
5 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Readiness Considerations
|
4 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Frequently Asked Questions (FAQs)
|
8 Participants
|
11 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Prescheduled Appointments (DI)
|
0 Participants
|
18 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Transportation services (DI)
|
0 Participants
|
10 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
PrEP Communication Options Tool (DI)
|
0 Participants
|
8 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Implementation guidance video (DI)
|
0 Participants
|
10 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
How to discuss sexual health guidance (DI)
|
0 Participants
|
3 Participants
|
|
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI
Acquisition Tracker (DI)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. All questions were not administered to both RI and DI arms; hence only participants with data available for the specified analysis at the specified time points were included.
Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, PSPs provided their insights regarding the tools and strategies used for delivering APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Participant handbook
|
10 Participants
|
7 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Patient brochure
|
12 Participants
|
7 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
What to expect video (DI)
|
0 Participants
|
13 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Myths facts video (DI)
|
0 Participants
|
9 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Getting Started brochure
|
9 Participants
|
10 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Patient website (RI)
|
11 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
HIV education video (DI)
|
0 Participants
|
11 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
ViiV Connect Assistance Video (DI)
|
0 Participants
|
6 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Reminder service text (DI)
|
0 Participants
|
7 Participants
|
|
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)
Appointment scheduler (DI)
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP. Only those participants with data available for the specified analysis at the specified time points were included.
This outcome measure evaluates the number of injections occurring within the target window. The target window is defined as ± 7 days from target date of injection for Dose 2 and subsequent injections. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=81 Injections
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=111 Injections
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 4
|
49 Injections
|
66 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 5
|
45 Injections
|
50 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 8
|
0 Injections
|
0 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 6
|
30 Injections
|
44 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 7
|
27 Injections
|
35 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 2
|
76 Injections
|
103 Injections
|
|
Number of Injections Occurring Within Target Window From Target Date
Dose 3
|
57 Injections
|
77 Injections
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP. Only those participants with data available for the specified analysis at the specified time points were included.
Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Completing Target Number of Injections
|
63 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs provided their insights into how APRETUDE has been incorporated into their daily lives, including factors that supported its delivery. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
APRETUDE Fitting life
|
20 Participants
|
23 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
Clinic staff supporting incorporation of APRETUDE into schedule
|
10 Participants
|
15 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
Booking appointments in advance
|
11 Participants
|
13 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
Easy to fit into life (convenience, etc.)
|
8 Participants
|
16 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
No transportation issues
|
15 Participants
|
5 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
Good fit with work schedule
|
6 Participants
|
13 Participants
|
|
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections
Clinic hours aligned with patient schedule
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs reported several challenges related to incorporating APRETUDE into their daily lives. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Perceptions of Barriers to Fidelity to Injections
Work challenges
|
5 Participants
|
2 Participants
|
|
Number of PSPs With Perceptions of Barriers to Fidelity to Injections
Discomfort
|
11 Participants
|
14 Participants
|
|
Number of PSPs With Perceptions of Barriers to Fidelity to Injections
Clinic challenges
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points.
Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the facilitators for adherence to APRETUDE and the support provided to enable patient adherence. These facilitators were categorized as resources, support, patient communication and patient feasibility. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=16 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Resources: Dedicated injection nurse for follow-up
|
3 Participants
|
2 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Resources: Dedicated support staff for each step: education, authorization, etc
|
0 Participants
|
4 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Resources: Communication (call, email and text)
|
2 Participants
|
7 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Resources: Patient education about importance of adherence
|
4 Participants
|
1 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Resources: Flexibility of using oral PrEP for bridging when needed
|
3 Participants
|
1 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Support: Scheduling appointments in advance
|
3 Participants
|
4 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Support: Team dedicated for follow-up
|
1 Participants
|
5 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient Communication: Increasing global communication
|
5 Participants
|
6 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient Communication: Encouraging proactively engaging patients with scheduling
|
3 Participants
|
6 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient Communication: Accessibility for patients for open line communication
|
2 Participants
|
8 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient feasibility: APRETUDE is feasible for patients
|
3 Participants
|
9 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient feasibility: Clinical staff making the process run smoothly
|
4 Participants
|
4 Participants
|
|
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections
Patient feasibility: Working around patient schedule helps with feasibility
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available for the specified analysis at the specified time points.
Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the barriers and challenges in enabling patient adherence to APRETUDE. The barriers were categorized as patient barriers and staff challenges. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=16 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Patient Barriers: Scheduling Barriers
|
2 Participants
|
4 Participants
|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Patient Barriers: Vulnerable Population
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Patient Barriers: Traveling
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Patient Barriers: Patients hard to contact (e.g., no phone access)
|
2 Participants
|
2 Participants
|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Staff Challenges: Concern about patients missing injection window
|
2 Participants
|
4 Participants
|
|
Number of SSPs With Perceptions of Barriers to Fidelity to Injections
Staff Challenges: Not being able to contact patients who miss an appointment
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, SSPs answered questions about their administration of the sexual health assessment (SHA). The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=52 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Who Administer Sexual Health Assessment (SHA)
Yes
|
—
|
14 Participants
|
|
Number of SSPs Who Administer Sexual Health Assessment (SHA)
No And Not Planning to Use the Sexual Health Assessment
|
—
|
14 Participants
|
|
Number of SSPs Who Administer Sexual Health Assessment (SHA)
No But Planning to Use the Sexual Health Assessment
|
—
|
4 Participants
|
|
Number of SSPs Who Administer Sexual Health Assessment (SHA)
I don't know
|
—
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one SHA survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, data shown below describes the number of PSPs to which the SHA was administered. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Eligible PSPs for Which SHA Are Administered
I don't know
|
15 Participants
|
23 Participants
|
|
Number of Eligible PSPs for Which SHA Are Administered
Missing
|
21 Participants
|
40 Participants
|
|
Number of Eligible PSPs for Which SHA Are Administered
Yes
|
35 Participants
|
39 Participants
|
|
Number of Eligible PSPs for Which SHA Are Administered
No
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: The protocol-defined endpoint for this outcome specifically requires data presentation by MSM and TGM, so data here are displayed by those groups. Data for this endpoint was collected from all MSM and TGM across DI and RI arms in alignment with the objective, therefore the analysis by MSM and TGM was not completed within arms but across arms.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=12 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=189 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12
Yes
|
1 Participants
|
73 Participants
|
|
Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12
No
|
3 Participants
|
25 Participants
|
|
Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12
I don't know
|
2 Participants
|
36 Participants
|
|
Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12
Missing
|
6 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: As pre-specified in the protocol, this outcome measure was evaluated in the MSM and TGM separately. Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one SHA survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, data shown below describes the number of MSM and TGM who reported having had sex in the last 6 months. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=12 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=189 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA
I prefer not to answer
|
0 Participants
|
1 Participants
|
|
Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA
Yes
|
5 Participants
|
128 Participants
|
|
Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA
Missing
|
6 Participants
|
55 Participants
|
|
Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA
No
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one SHA survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, data presented below shows the number of PSPs who expressed interest in PreP by responding to the question "Have you taken oral PreP in the last 6 months" and number of PSPs who had not heard of PreP.
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Have you taken oral PrEP in the last 6 months? · Yes
|
65 Participants
|
77 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, had you heard of APRETUDE? · Missing
|
5 Participants
|
10 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Have you taken oral PrEP in the last 6 months? · No
|
11 Participants
|
26 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, you ever heard of people without HIV taking oral PrEP pills? · I don't know/prefer not to answer
|
3 Participants
|
7 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, you ever heard of people without HIV taking oral PrEP pills? · Yes
|
61 Participants
|
70 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, you ever heard of people without HIV taking oral PrEP pills? · No
|
15 Participants
|
30 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, you ever heard of people without HIV taking oral PrEP pills? · Missing
|
5 Participants
|
10 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, had you heard of APRETUDE? · Yes
|
58 Participants
|
68 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, had you heard of APRETUDE? · No
|
21 Participants
|
39 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Before enrolling in this study, had you heard of APRETUDE? · I don't know/prefer not to answer
|
0 Participants
|
0 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Have you taken oral PrEP in the last 6 months? · I don't know/prefer not to answer
|
1 Participants
|
2 Participants
|
|
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months
Have you taken oral PrEP in the last 6 months? · Missing
|
7 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one SHA survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, PSPs were asked if they had taken oral PreP in the last 6 months. PSPs who answered 'No' or 'I prefer not to answer' were further asked if they had ever taken oral PreP. Timeframe for evaluation of this outcome measure is through M12(equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you ever taken oral PrEP · No
|
0 Participants
|
11 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you ever taken oral PrEP · I prefer not to answer
|
0 Participants
|
1 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you ever taken oral PrEP · Missing
|
11 Participants
|
11 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you taken oral PrEP in the last 6 months? · Yes
|
65 Participants
|
77 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you taken oral PrEP in the last 6 months? · No
|
11 Participants
|
26 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you taken oral PrEP in the last 6 months? · I prefer not to answer
|
1 Participants
|
2 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you taken oral PrEP in the last 6 months? · Missing
|
7 Participants
|
12 Participants
|
|
Number of PSPs Who Initiate APRETUDE After Taking the SHA
Have you ever taken oral PrEP · Yes
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. This question was not administered to the RI arm; hence they were not assessed. Only those participants with data available at the specified time points were analyzed.
Perceptions of the sexual health assessment (SHA) among PSPs were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Perceptions of SHA
SHA was received by PSPs
|
0 Participants
|
16 Participants
|
|
Number of PSPs With Perceptions of SHA
SHA was not received by PSPs
|
0 Participants
|
3 Participants
|
|
Number of PSPs With Perceptions of SHA
SHA received/not received- Missing
|
0 Participants
|
4 Participants
|
|
Number of PSPs With Perceptions of SHA
SHA found useful by PSPs
|
0 Participants
|
15 Participants
|
|
Number of PSPs With Perceptions of SHA
SHA not found useful by PSPs
|
0 Participants
|
0 Participants
|
|
Number of PSPs With Perceptions of SHA
SHA found useful/not useful- Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on SSPs who completed at least one survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, SSPs provided insights regarding the use and implementation of SHA tool in their clinic/practice. The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=18 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment helps/will help to facilitate conversations about PrEP with patients · Agree
|
—
|
8 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be easy to implement in my clinic/practice · Completely disagree
|
—
|
1 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be easy to implement in my clinic/practice · Disagree
|
—
|
1 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be easy to implement in my clinic/practice · Neither agree nor disagree
|
—
|
3 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be easy to implement in my clinic/practice · Agree
|
—
|
8 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be easy to implement in my clinic/practice · Completely agree
|
—
|
5 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be an easy way to identify individuals interested in PrEP · Completely disagree
|
—
|
1 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be an easy way to identify individuals interested in PrEP · Disagree
|
—
|
0 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be an easy way to identify individuals interested in PrEP · Neither agree nor disagree
|
—
|
3 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be an easy way to identify individuals interested in PrEP · Agree
|
—
|
10 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment is/will be an easy way to identify individuals interested in PrEP · Completely agree
|
—
|
4 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment helps/will help to facilitate conversations about PrEP with patients · Completely disagree
|
—
|
1 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment helps/will help to facilitate conversations about PrEP with patients · Disagree
|
—
|
0 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment helps/will help to facilitate conversations about PrEP with patients · Neither agree nor disagree
|
—
|
3 Participants
|
|
Number of SSPs With Perceptions of SHA
The Sexual Health Assessment helps/will help to facilitate conversations about PrEP with patients · Completely agree
|
—
|
6 Participants
|
SECONDARY outcome
Timeframe: At Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12Population: Analysis was performed on data submitted from SSPs who completed at least one FRAME-IS assessment at any time point and had data available for the specified analysis at the specified time points.
The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize all modifications reported by SSPs during PILLAR study. Timeframe for evaluation of this outcome measure is from M2 to M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 2 Modifications
|
3 Number of Modifications
|
6 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 3 Modifications
|
8 Number of Modifications
|
4 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 4 Modifications
|
0 Number of Modifications
|
3 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 5 Modifications
|
5 Number of Modifications
|
3 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 6 Modifications
|
3 Number of Modifications
|
4 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 7 Modifications
|
4 Number of Modifications
|
1 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 8 Modifications
|
2 Number of Modifications
|
3 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 9 Modifications
|
0 Number of Modifications
|
2 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 10 Modifications
|
0 Number of Modifications
|
10 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 11 Modifications
|
0 Number of Modifications
|
2 Number of Modifications
|
|
Number of Modifications Reported by SSPs Using FRAME-IS
Trial Month 12 Modifications
|
1 Number of Modifications
|
5 Number of Modifications
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on data submitted from SSPs who completed at least one FRAME-IS assessment at any time point and had data available for the specified analysis at the specified time points.
The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the types of modifications and adaptations reported by SSPs during PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Modifications for Each Category Reported by SSPs Using FRAME-IS
Content: Modification made to the content of APRETUDE materials and tools
|
4 Number of Modifications
|
12 Number of Modifications
|
|
Number of Modifications for Each Category Reported by SSPs Using FRAME-IS
Evaluation: Modification made to the staff evaluate whether APPRETUDE is working
|
3 Number of Modifications
|
5 Number of Modifications
|
|
Number of Modifications for Each Category Reported by SSPs Using FRAME-IS
Training: Modification made to the staff delivering APRETUDE are trained
|
0 Number of Modifications
|
22 Number of Modifications
|
|
Number of Modifications for Each Category Reported by SSPs Using FRAME-IS
Contextual: Modification made to the overall implementation of APRETUDE injection delivered
|
22 Number of Modifications
|
30 Number of Modifications
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on data submitted from SSPs who completed at least one FRAME-IS assessment at any time point and had data available for the specified analysis at the specified time points.
The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the perceptions and motivations of adaptations to implementation reported by SSPs using FRAME-IS. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=30 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=56 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS
Increase the number of patients with access to APRETUDE
|
5 Number of Modifications
|
23 Number of Modifications
|
|
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS
Improve feasibility of the implementation effort
|
8 Number of Modifications
|
19 Number of Modifications
|
|
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS
Improve fit with the clinical/practice setting
|
10 Number of Modifications
|
18 Number of Modifications
|
|
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS
Increase satisfaction with the implementation effort
|
11 Number of Modifications
|
17 Number of Modifications
|
|
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS
Speed up injection/implementation process
|
12 Number of Modifications
|
17 Number of Modifications
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
PSP perceptions of adaptations to implementation strategies were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discussed their use of study resources and recommendations to staff for delivery of APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Discussed tools and resources
|
20 Participants
|
21 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Positive feedback about tools and resources
|
7 Participants
|
10 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Only used tools/resources in the beginning of PILLAR
|
7 Participants
|
5 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Does not remember tools or resources
|
5 Participants
|
3 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Resources were helpful
|
4 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Negative feedback about tools and resources
|
4 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Did not use (pay much attention to resources)
|
2 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Recommendations to staff
|
14 Participants
|
16 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Would not change anything
|
3 Participants
|
4 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
APRETUDE education within the community
|
3 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Being culturally aware and non-judgmental
|
2 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Support APRETUDE schedule
|
1 Participants
|
2 Participants
|
|
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies
Discussion about post-Injection discomfort
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ and SHA survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
In this outcome measure, PSPs who completed the SHA and ISQ, describe the history of PrEP use and of sexual health assessment use for determination of PreP use during PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=35 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=39 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
Have you ever taken oral PrEP- No
|
0 Participants
|
11 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
Have you ever taken oral PrEP- Prefer not to answer
|
0 Participants
|
1 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
Have you ever taken oral PrEP- Missing
|
11 Participants
|
11 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
Have you ever taken oral PrEP- Yes
|
1 Participants
|
5 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
The SHA asked questions to determine if PrEP was right for me- Completely disagree
|
1 Participants
|
2 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
The SHA asked questions to determine if PrEP was right for me- Disagree
|
1 Participants
|
0 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
The SHA asked questions to determine if PrEP was right for me- Neither agree nor disagree
|
7 Participants
|
5 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
The SHA asked questions to determine if PrEP was right for me- Agree
|
11 Participants
|
19 Participants
|
|
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE
The SHA asked questions to determine if PrEP was right for me- Completely Agree
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on all PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
Reasons for choosing and switching to APRETUDE were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews among PSPs. In this outcome measure, PSPs shared previous oral PrEP experiences, comparisons of other forms of PrEP to APRETUDE, and reasons for preferring APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
Oral PrEP used: Challenges remembering to take pill every day
|
11 Participants
|
16 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
Oral PrEP used: Side effects of oral PrEP
|
3 Participants
|
6 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
APRETUDE differences to oral PrEP: Better adherence and feeling more protected
|
5 Participants
|
4 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
APRETUDE differences to oral PrEP: APRETUDE More convenient than Oral
|
2 Participants
|
6 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
APRETUDE differences to oral PrEP: Less/ No side effects related to oral PrEP
|
5 Participants
|
0 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
Prefer APRETUDE over Oral PrEP: More convenient
|
8 Participants
|
14 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)
Prefer APRETUDE over Oral PrEP: Less/No side effects
|
5 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed at least one ISQ survey at any timepoint. Only those participants with data available for the specified analysis at the specified time points were included.
The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs answered ISQ regarding reasons for choosing to take APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=84 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=117 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs
I want a prevention option that is more convenient for my life
|
49 Participants
|
66 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs
I won't have to remember to take PrEP everyday
|
45 Participants
|
63 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs
I do not have to worry or stress about missing a dose like oral PrEP
|
47 Participants
|
55 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs
I want to try a new approach and see if it fits into my life
|
27 Participants
|
43 Participants
|
|
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs
I will not have to worry about HIV every day
|
27 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
General perceptions of facilitators for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss views of long-term use of APRETUDE, reasons to choose APRETUDE, and experiences with clinic staff. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perception of Facilitators
Would consider APRETUDE as a long-term treatment
|
17 Participants
|
19 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
APRETUDE as long-term treatment provides protection
|
6 Participants
|
12 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
APRETUDE as long-term treatment provides peace of mind
|
6 Participants
|
4 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
APRETUDE as long-term treatment has concerns about insurance coverage long-term
|
3 Participants
|
4 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
APRETUDE as long-term treatment has convenience over oral PrEP
|
1 Participants
|
5 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
APRETUDE as long-term treatment taken as long as necessary
|
5 Participants
|
0 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Reasons others may choose APRETUDE: Convenience and ease of use
|
3 Participants
|
8 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Reasons others may choose APRETUDE: Health and prevention
|
5 Participants
|
4 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Global judgement of recommend to others
|
14 Participants
|
13 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Experiences of care: Discussed interactions with clinic staff
|
21 Participants
|
21 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Experiences of care: Clinic staff were friendly and kind
|
19 Participants
|
17 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Experiences of care: PSP was treated with respect
|
15 Participants
|
15 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Experiences of care: Clinic staff were knowledgeable
|
7 Participants
|
12 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Experiences of care: Shared decision making
|
9 Participants
|
10 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
HIV/STI testing: Testing frequency was acceptable
|
15 Participants
|
13 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
HIV/STI testing: Positive experience with scheduling HIV/ STI testing
|
11 Participants
|
11 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Reported whether they discussed APRETUDE with family / friends
|
18 Participants
|
21 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Has discussed APRETUDE with partner(s)
|
9 Participants
|
11 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Peers have started PrEP
|
7 Participants
|
10 Participants
|
|
Number of PSPs Assessed for Perception of Facilitators
Uptake of PrEP by Friends
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on PSPs who were administered at least one dose of APRETUDE injection or of CAB tablets for PrEP and who completed an interview at the specified time point. Only those participants with data available for the specified analysis at the specified time points were included.
General perceptions of barriers for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss challenging views of or experiences with APRETUDE receipt. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).
Outcome measures
| Measure |
RI - SSP
n=21 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=23 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of PSPs Assessed for Perception of Barriers
Would not consider APRETUDE as a long-term treatment
|
3 Participants
|
1 Participants
|
|
Number of PSPs Assessed for Perception of Barriers
Cost Challenges
|
3 Participants
|
6 Participants
|
|
Number of PSPs Assessed for Perception of Barriers
Challenges with switching insurance carriers
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available at the specified time points.
General perceptions of facilitators for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss clinic culture and implementation motivations. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=16 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perception of Facilitators
Supportive leadership for implementation
|
11 Participants
|
11 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
Leadership willing to help/support
|
8 Participants
|
6 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
Leadership being actively involved in the process
|
5 Participants
|
4 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
APRETUDE positively accepted
|
5 Participants
|
10 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
Team adaptability
|
3 Participants
|
8 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
Staff being supportive of the clinic offering APRETUDE
|
6 Participants
|
11 Participants
|
|
Number of SSPs Assessed for Perception of Facilitators
Aiming to improve patient's health
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Month 12Population: Analysis was performed on the SSPs who were interviewed and had data available at the specified time points.
General perceptions of barriers for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss feelings and perspectives while implementing APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).
Outcome measures
| Measure |
RI - SSP
n=16 Participants
Staff at sites offering APRETUDE injection for PrEP. SSPs had access to standard toolkits for APRETUDE to use as needed.
|
DI - SSP
n=25 Participants
Staff at sites offering APRETUDE injection for pre- exposure prophylaxis (PrEP). SSPs had access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE.
|
|---|---|---|
|
Number of SSPs Assessed for Perception of Barriers
Staff having mixed feelings
|
4 Participants
|
9 Participants
|
|
Number of SSPs Assessed for Perception of Barriers
Initial negative response due to extra workload
|
2 Participants
|
2 Participants
|
Adverse Events
Dynamic Implementation (DI) - PSP
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Routine Implementation (RI) - PSP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dynamic Implementation (DI) - PSP
n=117 participants at risk
Men who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.
|
Routine Implementation (RI) - PSP
n=84 participants at risk
MSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
0.00%
0/84 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
0.00%
0/84 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
0.00%
0/84 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
Other adverse events
| Measure |
Dynamic Implementation (DI) - PSP
n=117 participants at risk
Men who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.
|
Routine Implementation (RI) - PSP
n=84 participants at risk
MSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.
|
|---|---|---|
|
General disorders
Injection site pain
|
1.7%
2/117 • Number of events 2 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
4.8%
4/84 • Number of events 4 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
General disorders
Fatigue
|
1.7%
2/117 • Number of events 2 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
2.4%
2/84 • Number of events 2 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
General disorders
Injection site reaction
|
0.00%
0/117 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
General disorders
Pain
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
0.00%
0/84 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
General disorders
Peripheral swelling
|
0.00%
0/117 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/117 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Gastrointestinal disorders
Nausea
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
0.00%
0/84 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Psychiatric disorders
Depressed mood
|
0.85%
1/117 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/117 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/117 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
1.2%
1/84 • Number of events 1 • Serious adverse events (SAEs) were reported from signing of informed consent (a period starting up to 90 days before the first dose in Month 1) to Month 12 (study completion). Non serious Drug related AEs were reported from Month 1 (first dose) to Month 12 (study completion).
Month 12 (study completion) is equivalent to Month 13 for PSPs who received OLI and for SSPs who assessed PSPs receiving OLI. Adverse events for SSPs were not collected as it was not required as per study design.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER