Trial Outcomes & Findings for AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial (NCT NCT03916484)
NCT ID: NCT03916484
Last Updated: 2023-05-24
Results Overview
The average proportion of days of any app use during the trial across all participants as recorded by the app backend para data. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
180 days
Results posted on
2023-05-24
Participant Flow
Participants were recruited from 6 clinical recruitment sites in Birmingham, AL; Chapel Hill and Charlotte, NC; Charleston, SC; Detroit, MI and Newark, NJ.
Enrollment and randomization to stage 1 interventions took place directly following confirmation of eligibility and completion of informed consent. All enrolled participants were randomized and assigned to a stage 1 intervention condition.
Participant milestones
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
AQ Followed by AQ+NSC
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
AQ+NSC Followed by AQ
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
|---|---|---|---|---|
|
Stage 1 Intervention (Months 1-3)
STARTED
|
7
|
41
|
15
|
8
|
|
Stage 1 Intervention (Months 1-3)
COMPLETED
|
7
|
40
|
15
|
8
|
|
Stage 1 Intervention (Months 1-3)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Stage 2 Intervention (Months 4-6)
STARTED
|
7
|
40
|
15
|
8
|
|
Stage 2 Intervention (Months 4-6)
COMPLETED
|
5
|
29
|
11
|
7
|
|
Stage 2 Intervention (Months 4-6)
NOT COMPLETED
|
2
|
11
|
4
|
1
|
Reasons for withdrawal
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
AQ Followed by AQ+NSC
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
AQ+NSC Followed by AQ
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app.
AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
|
|---|---|---|---|---|
|
Stage 1 Intervention (Months 1-3)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Stage 2 Intervention (Months 4-6)
Lost to Follow-up
|
2
|
11
|
4
|
1
|
Baseline Characteristics
This survey question was optional for participants. The number analyzed includes all participants who answered this question.
Baseline characteristics by cohort
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=7 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=41 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=15 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=8 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=7 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=71 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=7 Participants
|
39 Participants
n=41 Participants
|
14 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
67 Participants
n=71 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=71 Participants
|
|
Age, Continuous
|
24.28 years
n=7 Participants
|
22.43 years
n=41 Participants
|
22.13 years
n=15 Participants
|
22.37 years
n=8 Participants
|
22.54 years
n=71 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=71 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=7 Participants
|
41 Participants
n=41 Participants
|
15 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
71 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=7 Participants
|
5 Participants
n=41 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=7 Participants
|
35 Participants
n=41 Participants
|
13 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
62 Participants
n=71 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=71 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=7 Participants
|
27 Participants
n=41 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
49 Participants
n=71 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=7 Participants
|
3 Participants
n=41 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=71 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
8 Participants
n=41 Participants
|
5 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=71 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=71 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=7 Participants
|
41 Participants
n=41 Participants
|
15 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
71 Participants
n=71 Participants
|
|
Mean Percent of Past 30-Day ART medication adherence
|
98.00 percentage of doses taken
STANDARD_DEVIATION 2.73 • n=5 Participants • This survey question was optional for participants. The number analyzed includes all participants who answered this question.
|
81.05 percentage of doses taken
STANDARD_DEVIATION 28.37 • n=35 Participants • This survey question was optional for participants. The number analyzed includes all participants who answered this question.
|
78.09 percentage of doses taken
STANDARD_DEVIATION 28.59 • n=11 Participants • This survey question was optional for participants. The number analyzed includes all participants who answered this question.
|
94.00 percentage of doses taken
STANDARD_DEVIATION 12.67 • n=8 Participants • This survey question was optional for participants. The number analyzed includes all participants who answered this question.
|
83.69 percentage of doses taken
STANDARD_DEVIATION 25.98 • n=59 Participants • This survey question was optional for participants. The number analyzed includes all participants who answered this question.
|
|
Participants with viral suppression
|
2 Participants
n=7 Participants
|
14 Participants
n=41 Participants
|
8 Participants
n=15 Participants
|
5 Participants
n=8 Participants
|
29 Participants
n=71 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: Per the pre-specified analysis plan, this outcome compares how effective each intervention sequence performed as measured by participants' daily use of the intervention app with the 4 sequences offering different intervention intensity variations.
The average proportion of days of any app use during the trial across all participants as recorded by the app backend para data. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=7 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=41 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=15 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=8 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=71 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Intervention Feasibility: Average Proportion of Days of Any App Use
|
0.64 proportion of days
Standard Deviation 0.17
|
0.40 proportion of days
Standard Deviation 0.33
|
0.27 proportion of days
Standard Deviation 0.14
|
0.64 proportion of days
Standard Deviation 0.16
|
0.42 proportion of days
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: 180 DaysPopulation: Per the pre-specified analysis plan, this outcome compares how effective each intervention sequence performed as measured by participants' daily use of the intervention app to track daily medication with the 4 sequences offering different intervention intensity variations.
The average proportion of days participants used the app to track their HIV medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=7 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=41 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=15 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=8 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=71 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked
|
0.80 proportion of days
Standard Deviation 0.15
|
0.50 proportion of days
Standard Deviation 0.33
|
0.38 proportion of days
Standard Deviation 0.20
|
0.81 proportion of days
Standard Deviation 0.13
|
0.54 proportion of days
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: The protocol was amended to utilize a more precise scale for this measure (see outcome #4). The CSQ-8® was not administered and no data were collected using this tool.
The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Participants could choose to decline to answer some or all of the self-reported CASI responses to intervention acceptability measures. This analysis includes all participants who answered half or more (\>=11) of the 22 items on the AHAA scale.
The mean composite score is calculated from the Acceptability of Health Apps among Adolescents (AHAA) scale, a 22-item validated scale measuring the construct of global intervention acceptability. Item response options include: Strongly Disagree, Disagree, Agree, Strongly Agree. Scale items are grouped into 6 sub-scales. Responses to the items in each sub-scale are averaged and the sub-scale averages are added to obtain a total possible composite score ranging from 6 (lowest acceptability, worst outcome) to 24 (highest acceptable, best outcome). A score of 18 or higher is consistent with overall high acceptability.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=6 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=28 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=7 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=6 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=47 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Intervention Acceptability: Mean Intervention Acceptability Score
|
20.95 score on a scale
Standard Deviation 1.37
|
19.97 score on a scale
Standard Deviation 2.32
|
18.36 score on a scale
Standard Deviation 0.61
|
17.06 score on a scale
Standard Deviation 4.23
|
19.48 score on a scale
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: Month 6 follow-up time pointPopulation: Data are reported for all participants who completed this question on the 6-month follow-up survey
HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of ART doses taken in the past 30 days.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=5 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=20 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=11 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=7 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=43 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Mean Percent of Past 30-Day ART Medication Adherence
|
99.00 percentage of doses taken
Standard Deviation 1.73
|
88.15 percentage of doses taken
Standard Deviation 22.47
|
97.09 percentage of doses taken
Standard Deviation 4.32
|
84.42 percentage of doses taken
Standard Deviation 25.35
|
91.09 percentage of doses taken
Standard Deviation 18.80
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Analysis population includes all those who answered this question on both the Baseline and the Month 6 follow-up surveys.
HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of prescribed ART doses taken in the past 30 days. Assessed at Baseline and Month 6 follow-up time point.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=4 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=18 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=7 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=7 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=36 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Mean Percent ART Medication Adherence Over Time
Baseline
|
98.75 percentage of medication taken
Standard Deviation 2.50
|
80.77 percentage of medication taken
Standard Deviation 31.10
|
73.00 percentage of medication taken
Standard Deviation 32.34
|
98.42 percentage of medication taken
Standard Deviation 2.07
|
84.69 percentage of medication taken
Standard Deviation 27.31
|
|
Mean Percent ART Medication Adherence Over Time
Month 6 Follow-up
|
98.75 percentage of medication taken
Standard Deviation 1.89
|
87.16 percentage of medication taken
Standard Deviation 23.53
|
96.85 percentage of medication taken
Standard Deviation 5.17
|
84.42 percentage of medication taken
Standard Deviation 25.35
|
89.80 percentage of medication taken
Standard Deviation 20.31
|
SECONDARY outcome
Timeframe: Month 6 follow-up time pointPopulation: All participants with an available viral load lab measure for the 6-month follow-up time point.
Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. The study will report the number of participants who are virally suppressed at 6 month follow-up.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=5 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=25 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=11 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=7 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=48 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Number of Participants With Viral Suppression
|
3 Participants
|
19 Participants
|
8 Participants
|
3 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: up to 3 monthsPopulation: Includes all participants who had available clinical viral load measures at both baseline and month 3 follow-up. This outcome reports on viral suppression at the end of Stage 1 of the intervention (Month 3 follow-up visit).
Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 3 follow-up time point.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=15 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=33 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=48 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
All enrolled participants
|
|---|---|---|---|---|---|
|
Percent of Participants With Viral Suppression Over Time
Baseline
|
40.00 percent of participants
|
33.33 percent of participants
|
35.42 percent of participants
|
—
|
—
|
|
Percent of Participants With Viral Suppression Over Time
Month 3 follow-up
|
80.00 percent of participants
|
75.76 percent of participants
|
77.08 percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Population includes all participants with an available clinical viral load measure at both the baseline and month 6 follow-up.
Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 6 follow-up.
Outcome measures
| Measure |
AQ HIV Medication Adherence App-delivered Intervention
n=5 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6.
|
AQ HIV Medication Adherence App-delivered Intervention + NSC
n=25 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6.
|
AQ Followed by AQ+NSC
n=11 Participants
Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness.
|
AQ+NSC Followed by AQ
n=7 Participants
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness.
|
Total Sample
n=48 Participants
All enrolled participants
|
|---|---|---|---|---|---|
|
Percent of Participants With Viral Suppression Over Time
Baseline
|
0.00 percent of participants
|
28.00 percent of participants
|
45.45 percent of participants
|
71.43 percent of participants
|
35.42 percent of participants
|
|
Percent of Participants With Viral Suppression Over Time
Month 6 follow-up
|
60.00 percent of participants
|
76.00 percent of participants
|
72.73 percent of participants
|
42.86 percent of participants
|
68.75 percent of participants
|
Adverse Events
Stage 1: (Months 1-3) AQ HIV Medication Adherence App-delivered Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 1: (Months 1-3) AQ+NSC HIV Medication Adherence App-delivered Intervention + NSC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: (Months 4-6) AQ HIV Medication Adherence App-delivered Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stage 2: (Months 4-6) AQ HIV Medication Adherence App-delivered Intervention + NSC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kate Muessig, PhD
University of North Carolina at Chapel Hill
Phone: 850-644-3299
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place