Trial Outcomes & Findings for PrEP Communication Intervention for Female Clients of a Needle Exchange (NCT NCT03541642)
NCT ID: NCT03541642
Last Updated: 2024-02-05
Results Overview
Self-report PrEP adherence and bio-verified PrEP adherence to PrEP with urine assay (Synergy medical labs - Descovy Panel TFV:Creatinine Ratio-Descovy). Urine assay results will be categorized as a binary variable (yes/no) based upon value observed by all patients, with data at 1 month, 3 months and 3 months post intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
one month, three months, three months post intervention
Results posted on
2024-02-05
Participant Flow
Participants were recruited for the pilot clinical trial from September 2020 to September 2021. Participants were recruited for the formative work that was done prior to developing the intervention on June 1, 2018. All were self-identified females who were clients of Prevention Point Philadelphia, a social services agency and syringe services exchange.
A total of 35 participants were randomized to intervention or control arms. IRB required us to consent women prior to eligibility due to HIPAA. In total, forty nine women were recruited and 48 consented for the study prior to eligibility. Of these, 12 were found to be not eligible based on criteria (i.e. previously used PrEP, no reported HIV risk behavior, no phone). Of the 36 remaining, one was lost before randomization could occur, resulting in a final group of 35 participants.
Participant milestones
| Measure |
Enhanced Intervention
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
1-month
|
3
|
4
|
|
Overall Study
3-month
|
1
|
3
|
|
Overall Study
3-month Follow-up
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
18
|
15
|
Reasons for withdrawal
| Measure |
Enhanced Intervention
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
16
|
12
|
|
Overall Study
Found out previously on PrEP after randomization before eligibility was expanded
|
1
|
1
|
Baseline Characteristics
Analysis population only includes cases that completed baseline. Note that one item of the CSE scale was inadvertently excluded from the baseline measure. Random imputation was used to populate a value from 0-10 for this missing item value prior to scoring the CSE.
Baseline characteristics by cohort
| Measure |
Enhanced Intervention
n=17 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=14 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
14 Participants
n=14 Participants
|
31 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
40.24 years
STANDARD_DEVIATION 10.35 • n=17 Participants
|
39.86 years
STANDARD_DEVIATION 8.54 • n=14 Participants
|
40.06 years
STANDARD_DEVIATION 9.42 • n=31 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=17 Participants
|
14 Participants
n=14 Participants
|
31 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=17 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=17 Participants
|
8 Participants
n=14 Participants
|
20 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=17 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=17 Participants
|
3 Participants
n=14 Participants
|
4 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
14 participants
n=14 Participants
|
31 participants
n=31 Participants
|
|
Coping Self-Efficacy
|
83.23 units on a scale
STANDARD_DEVIATION 15.85 • n=13 Participants • Analysis population only includes cases that completed baseline. Note that one item of the CSE scale was inadvertently excluded from the baseline measure. Random imputation was used to populate a value from 0-10 for this missing item value prior to scoring the CSE.
|
87.83 units on a scale
STANDARD_DEVIATION 18.90 • n=12 Participants • Analysis population only includes cases that completed baseline. Note that one item of the CSE scale was inadvertently excluded from the baseline measure. Random imputation was used to populate a value from 0-10 for this missing item value prior to scoring the CSE.
|
85.44 units on a scale
STANDARD_DEVIATION 17.17 • n=25 Participants • Analysis population only includes cases that completed baseline. Note that one item of the CSE scale was inadvertently excluded from the baseline measure. Random imputation was used to populate a value from 0-10 for this missing item value prior to scoring the CSE.
|
|
Decisional Conflict
|
4.35 units on a scale
STANDARD_DEVIATION 0.58 • n=17 Participants
|
4.28 units on a scale
STANDARD_DEVIATION 0.48 • n=14 Participants
|
4.32 units on a scale
STANDARD_DEVIATION 0.53 • n=31 Participants
|
|
PrEP Benefits
PrEP can keep me from getting HIV
|
9.06 units on a scale
STANDARD_DEVIATION 1.78 • n=17 Participants
|
9.07 units on a scale
STANDARD_DEVIATION 1.21 • n=14 Participants
|
9.06 units on a scale
STANDARD_DEVIATION 1.53 • n=31 Participants
|
|
PrEP Benefits
Using PrEP would make me feel more in charge of my life
|
7.71 units on a scale
STANDARD_DEVIATION 3.35 • n=17 Participants
|
8.36 units on a scale
STANDARD_DEVIATION 1.50 • n=14 Participants
|
8.00 units on a scale
STANDARD_DEVIATION 2.66 • n=31 Participants
|
|
PrEP Benefits
I would be able to enjoy sex more if I was taking PrEP
|
6.88 units on a scale
STANDARD_DEVIATION 3.33 • n=17 Participants
|
6.43 units on a scale
STANDARD_DEVIATION 3.94 • n=14 Participants
|
6.68 units on a scale
STANDARD_DEVIATION 3.33 • n=31 Participants
|
|
PrEP Benefits
PrEP is easy to take
|
9.41 units on a scale
STANDARD_DEVIATION 1.33 • n=17 Participants
|
9.79 units on a scale
STANDARD_DEVIATION 0.80 • n=14 Participants
|
9.58 units on a scale
STANDARD_DEVIATION 1.12 • n=31 Participants
|
|
PrEP Benefits
PrEP would not interfere with me injecting or taking drugs
|
9.00 units on a scale
STANDARD_DEVIATION 1.97 • n=17 Participants
|
8.64 units on a scale
STANDARD_DEVIATION 2.10 • n=14 Participants
|
8.84 units on a scale
STANDARD_DEVIATION 2.00 • n=31 Participants
|
|
PrEP Benefits
I would not have to rely on my partner to use condoms if I was taking PrEP
|
2.12 units on a scale
STANDARD_DEVIATION 2.85 • n=17 Participants
|
3.36 units on a scale
STANDARD_DEVIATION 3.78 • n=14 Participants
|
2.68 units on a scale
STANDARD_DEVIATION 3.30 • n=31 Participants
|
|
PrEP Benefits
I would only have to take one pill a day if I was on PrEP
|
9.18 units on a scale
STANDARD_DEVIATION 1.85 • n=17 Participants
|
9.14 units on a scale
STANDARD_DEVIATION 1.56 • n=14 Participants
|
9.16 units on a scale
STANDARD_DEVIATION 1.70 • n=31 Participants
|
|
PrEP Benefits
PrEP would let me worry less about HIV
|
9.29 units on a scale
STANDARD_DEVIATION 1.36 • n=17 Participants
|
8.07 units on a scale
STANDARD_DEVIATION 3.29 • n=14 Participants
|
8.74 units on a scale
STANDARD_DEVIATION 2.46 • n=31 Participants
|
|
PrEP Benefits
I would not have to feel guilty about. having fun if I took PrEP
|
5.41 units on a scale
STANDARD_DEVIATION 3.79 • n=17 Participants
|
6.07 units on a scale
STANDARD_DEVIATION 3.95 • n=14 Participants
|
5.71 units on a scale
STANDARD_DEVIATION 3.81 • n=31 Participants
|
|
PrEP Benefits
PrEP is affordable
|
8.35 units on a scale
STANDARD_DEVIATION 2.74 • n=17 Participants
|
8.36 units on a scale
STANDARD_DEVIATION 1.95 • n=14 Participants
|
8.35 units on a scale
STANDARD_DEVIATION 2.37 • n=31 Participants
|
|
PrEP Barriers
It would be hard for me to take a pill every day
|
1.41 units on a scale
STANDARD_DEVIATION 2.62 • n=17 Participants
|
1.93 units on a scale
STANDARD_DEVIATION 3.20 • n=14 Participants
|
1.65 units on a scale
STANDARD_DEVIATION 2.86 • n=31 Participants
|
|
PrEP Barriers
Taking PrEP would dull my high
|
0.59 units on a scale
STANDARD_DEVIATION 1.33 • n=17 Participants
|
0.64 units on a scale
STANDARD_DEVIATION 1.50 • n=14 Participants
|
0.61 units on a scale
STANDARD_DEVIATION 1.38 • n=31 Participants
|
|
PrEP Barriers
Taking PrEP would cause too many side effects
|
1.41 units on a scale
STANDARD_DEVIATION 2.15 • n=17 Participants
|
2.36 units on a scale
STANDARD_DEVIATION 2.41 • n=14 Participants
|
1.84 units on a scale
STANDARD_DEVIATION 2.28 • n=31 Participants
|
|
PrEP Barriers
I feel healthy so I don't need to take PrEP
|
1.12 units on a scale
STANDARD_DEVIATION 2.42 • n=17 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 3.35 • n=14 Participants
|
1.52 units on a scale
STANDARD_DEVIATION 2.86 • n=31 Participants
|
|
PrEP Barriers
I already protect myself from HIV in other ways (i.e., condoms, not sharing needles)
|
3.65 units on a scale
STANDARD_DEVIATION 4.00 • n=17 Participants
|
4.29 units on a scale
STANDARD_DEVIATION 3.34 • n=14 Participants
|
3.94 units on a scale
STANDARD_DEVIATION 3.67 • n=31 Participants
|
|
PrEP Barriers
Even if I take PrEP, I might get HIV anyway
|
4.82 units on a scale
STANDARD_DEVIATION 4.07 • n=17 Participants
|
5.50 units on a scale
STANDARD_DEVIATION 3.53 • n=14 Participants
|
5.13 units on a scale
STANDARD_DEVIATION 3.78 • n=31 Participants
|
|
PrEP Barriers
PrEP only protects against HIV, not other sexually transmitted infections
|
8.88 units on a scale
STANDARD_DEVIATION 2.45 • n=17 Participants
|
8.71 units on a scale
STANDARD_DEVIATION 2.05 • n=14 Participants
|
8.81 units on a scale
STANDARD_DEVIATION 2.24 • n=31 Participants
|
|
PrEP Barriers
My partner might hurt me if they knew I was on PrEP
|
0.41 units on a scale
STANDARD_DEVIATION 1.28 • n=17 Participants
|
0.86 units on a scale
STANDARD_DEVIATION 1.83 • n=14 Participants
|
0.61 units on a scale
STANDARD_DEVIATION 1.54 • n=31 Participants
|
|
PrEP Barriers
I have a lot more worries in my life than getting HIV
|
3.41 units on a scale
STANDARD_DEVIATION 3.97 • n=17 Participants
|
3.86 units on a scale
STANDARD_DEVIATION 3.53 • n=14 Participants
|
3.61 units on a scale
STANDARD_DEVIATION 3.72 • n=31 Participants
|
|
PrEP Barriers
If I started PrEP it would be hard to get to the doctor every three months
|
0.82 units on a scale
STANDARD_DEVIATION 1.38 • n=17 Participants
|
0.86 units on a scale
STANDARD_DEVIATION 1.70 • n=14 Participants
|
0.84 units on a scale
STANDARD_DEVIATION 1.51 • n=31 Participants
|
|
PrEP Barriers
I don't have a safe place to keep PrEP
|
1.71 units on a scale
STANDARD_DEVIATION 2.73 • n=17 Participants
|
1.36 units on a scale
STANDARD_DEVIATION 2.87 • n=14 Participants
|
1.55 units on a scale
STANDARD_DEVIATION 2.15 • n=31 Participants
|
|
PrEP Barriers
I would be afraid if I had PrEP it would get stolen
|
1.59 units on a scale
STANDARD_DEVIATION 2.15 • n=17 Participants
|
1.71 units on a scale
STANDARD_DEVIATION 2.84 • n=14 Participants
|
1.65 units on a scale
STANDARD_DEVIATION 2.44 • n=31 Participants
|
|
PrEP Beliefs
Sex workers need PrEP more than other people
|
5.29 units on a scale
STANDARD_DEVIATION 4.52 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.79 units on a scale
STANDARD_DEVIATION 3.45 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
4.61 units on a scale
STANDARD_DEVIATION 4.08 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
People who inject drugs need PrEP more than other people
|
6.00 units on a scale
STANDARD_DEVIATION 4.11 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
4.79 units on a scale
STANDARD_DEVIATION 4.00 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
5.45 units on a scale
STANDARD_DEVIATION 4.04 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
Gay men need PrEP more than other people
|
3.88 units on a scale
STANDARD_DEVIATION 3.48 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.64 units on a scale
STANDARD_DEVIATION 3.99 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.77 units on a scale
STANDARD_DEVIATION 3.66 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
Trans people need PrEP more than other people
|
3.65 units on a scale
STANDARD_DEVIATION 3.55 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.29 units on a scale
STANDARD_DEVIATION 3.58 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.48 units on a scale
STANDARD_DEVIATION 3.51 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
People from certain races/ethnicities need PrEP more than other people
|
1.65 units on a scale
STANDARD_DEVIATION 2.64 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
1.43 units on a scale
STANDARD_DEVIATION 2.17 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
1.55 units on a scale
STANDARD_DEVIATION 2.41 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
PrEP sounds too good to be true
|
2.19 units on a scale
STANDARD_DEVIATION 3.43 • n=16 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
2.14 units on a scale
STANDARD_DEVIATION 2.71 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
2.17 units on a scale
STANDARD_DEVIATION 3.06 • n=30 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
PrEP makes people think they are invincible (can't get HIV or other sexually transmitted infections)
|
2.12 units on a scale
STANDARD_DEVIATION 2.85 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.00 units on a scale
STANDARD_DEVIATION 3.66 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
2.52 units on a scale
STANDARD_DEVIATION 3.21 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
PrEP is safe and effective for women to use
|
9.24 units on a scale
STANDARD_DEVIATION 1.35 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
8.43 units on a scale
STANDARD_DEVIATION 2.74 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
8.87 units on a scale
STANDARD_DEVIATION 2.09 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
|
PrEP Beliefs
I am more likely to take PrEP if I am being paid to take it
|
2.71 units on a scale
STANDARD_DEVIATION 3.65 • n=17 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
3.07 units on a scale
STANDARD_DEVIATION 3.69 • n=14 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
2.87 units on a scale
STANDARD_DEVIATION 3.61 • n=31 Participants • One participant in the enhanced group did not provide a response to item "PrEP sounds too good to be true". Thus, the analysis population was reduced from 17 to 16.
|
PRIMARY outcome
Timeframe: one month, three months, three months post interventionPopulation: The enhanced intervention group analysis population at 1 month (n=3) differs from the overall enhanced intervention group n (17), and basic intervention group analysis population at 1 month (n=4) differs from the overall basic intervention group n (14) due to implementation barriers that prevented women from getting onto PrEP (e.g., lack of venous access, not returning for doctor appointment), and remaining adherent (failure to pick up meds, failure to show for appointments).
Self-report PrEP adherence and bio-verified PrEP adherence to PrEP with urine assay (Synergy medical labs - Descovy Panel TFV:Creatinine Ratio-Descovy). Urine assay results will be categorized as a binary variable (yes/no) based upon value observed by all patients, with data at 1 month, 3 months and 3 months post intervention.
Outcome measures
| Measure |
Enhanced Intervention
n=3 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=4 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
Change in PrEP Uptake and Adherence
1 month · Still taking PrEP, bio-verified
|
0 Participants
|
1 Participants
|
|
Change in PrEP Uptake and Adherence
1 month · Still taking PrEP, not bio-verified
|
2 Participants
|
3 Participants
|
|
Change in PrEP Uptake and Adherence
1 month · Not taking PrEP
|
1 Participants
|
0 Participants
|
|
Change in PrEP Uptake and Adherence
3 month · Still taking PrEP, bio-verified
|
0 Participants
|
1 Participants
|
|
Change in PrEP Uptake and Adherence
3 month · Still taking PrEP, not bio-verified
|
0 Participants
|
2 Participants
|
|
Change in PrEP Uptake and Adherence
3 month · Not taking PrEP
|
1 Participants
|
0 Participants
|
|
Change in PrEP Uptake and Adherence
3 month follow up · Still taking PrEP, bio-verified
|
0 Participants
|
0 Participants
|
|
Change in PrEP Uptake and Adherence
3 month follow up · Still taking PrEP, not bio-verified
|
0 Participants
|
0 Participants
|
|
Change in PrEP Uptake and Adherence
3 month follow up · Not taking PrEP
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: one month, three months, three months post interventionPopulation: Enhanced group at 1month (n=3) differs from the overall enhanced group n (17) \& basic group at 1 month (n=4) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout. No participant at 3 month follow up reported PrEP use.
Self report PrEP adherence measure of PrEP use within the past week. Item asks "Of the seven doses of PrEP you were supposed to take during the last week, how many doses would you say you missed? Responses range from 0 to 7.
Outcome measures
| Measure |
Enhanced Intervention
n=3 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=4 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
PrEP Adherence Within Past Week
1 month · 7 days
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 6 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 5 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 4 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 3 days
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 2 days
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 1 day
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
1 month · 0 days
|
0 Participants
|
4 Participants
|
|
PrEP Adherence Within Past Week
1 month · Unknown or not reported
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 7 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 6 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 5 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 4 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 3 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 2 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month · 1 day
|
0 Participants
|
1 Participants
|
|
PrEP Adherence Within Past Week
3 month · 0 days
|
0 Participants
|
2 Participants
|
|
PrEP Adherence Within Past Week
3 month · Unknown or not reported
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 7 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 6 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 5 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 4 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 3 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 2 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 1 day
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · 0 days
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Within Past Week
3 month follow up · Unknown or not reported
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: one month, three months, three months post interventionPopulation: Enhanced group at 1month (n=3) differs from the overall enhanced group n (17) \& basic group at 1 month (n=4) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout. No participant at 3 month follow up reported PrEP use.
One item Medication Adherence question (one item with 5 option scale). "Excellent, Very good, Good, Poor, Very Poor".
Outcome measures
| Measure |
Enhanced Intervention
n=3 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=4 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
PrEP Adherence Appraisal
1 month · Excellent
|
0 Participants
|
3 Participants
|
|
PrEP Adherence Appraisal
1 month · Very good
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
1 month · Good
|
2 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
1 month · Poor
|
0 Participants
|
1 Participants
|
|
PrEP Adherence Appraisal
1 month · Very poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
1 month · Unknown or not reported
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month · Excellent
|
0 Participants
|
2 Participants
|
|
PrEP Adherence Appraisal
3 month · Very good
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month · Good
|
0 Participants
|
1 Participants
|
|
PrEP Adherence Appraisal
3 month · Poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month · Very poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month · Unknown or not reported
|
1 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Excellent
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Very good
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Good
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Poor
|
0 Participants
|
0 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Very poor
|
1 Participants
|
1 Participants
|
|
PrEP Adherence Appraisal
3 month follow up · Unknown or not reported
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Three months, three months post-interventionPopulation: Analysis at 3 month and 3 month follow up only includes participants that remained in the study.
Assess coping self-efficacy using the Coping Self-Efficacy Scale (13 item scale; 0-10 scale). Zero=cannot do at all,5=moderately certain can do and 10=certain can do. An overall CSE score (from 0 to 130) is created by summing the item ratings, with higher scores indicating higher coping self-efficacy.
Outcome measures
| Measure |
Enhanced Intervention
n=1 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=3 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
Coping Self-Efficacy
3 month
|
122 units on a scale
|
101 units on a scale
Standard Deviation 28.51
|
|
Coping Self-Efficacy
3 month follow up
|
130 units on a scale
|
84 units on a scale
|
SECONDARY outcome
Timeframe: Three months, Three months post interventionPopulation: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
Assess decisional conflict with the Ottawa Decisional Conflict Scale. 13 items. 5 responses: Strongly Disagree (1), Disagree (2), Neither Agree or Disagree (3), Agree (4), Strongly Agree (5). Scores are summed and divided by the number of items(13) to produce an overall mean, ranging from 1 to 5. Lower scores indicate lower decisional conflict.
Outcome measures
| Measure |
Enhanced Intervention
n=1 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=3 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
Decisional Conflict
3 month
|
5.00 units on a scale
|
4.64 units on a scale
Standard Deviation 0.56
|
|
Decisional Conflict
3 month follow up
|
5.00 units on a scale
|
4.85 units on a scale
|
SECONDARY outcome
Timeframe: three months, three months post-interventionPopulation: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
10 items assessed perceived benefits of PrEP. Items are asked on a 0-10 Likert, with 0 = strongly agree, 5 = unsure, 10 = strongly agree. Thus, higher scores indicate greater agreement with that item.
Outcome measures
| Measure |
Enhanced Intervention
n=1 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=3 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
PrEP Benefits
3mo, PrEP can keep me from getting HIV
|
9.00 units on a scale
|
9.67 units on a scale
Standard Deviation 0.58
|
|
PrEP Benefits
3mo, Using PrEP would make me feel more in charge of my life
|
9.00 units on a scale
|
8.67 units on a scale
Standard Deviation 1.53
|
|
PrEP Benefits
3mo, I would be able to enjoy sex more if I was taking PrEP
|
2.00 units on a scale
|
8.67 units on a scale
Standard Deviation 1.53
|
|
PrEP Benefits
3mo, PrEP is easy to take
|
10.0 units on a scale
|
10.0 units on a scale
Standard Deviation 0
|
|
PrEP Benefits
3mo, PrEP would not interfere with me injecting or taking drugs
|
10.0 units on a scale
|
10.0 units on a scale
Standard Deviation 0
|
|
PrEP Benefits
3mo, I would not have to rely on my partner to use condoms if I was taking PrEP
|
10.0 units on a scale
|
4.33 units on a scale
Standard Deviation 4.93
|
|
PrEP Benefits
3mo, I would only have to take one pill a day if I was on PrEP
|
10.0 units on a scale
|
10.0 units on a scale
Standard Deviation 0
|
|
PrEP Benefits
3mo, PrEP would let me worry less about HIV
|
10.0 units on a scale
|
10.0 units on a scale
Standard Deviation 0
|
|
PrEP Benefits
3mo, I would not have to feel guilty about having fun if I took PrEP
|
7.00 units on a scale
|
8.00 units on a scale
Standard Deviation 2.00
|
|
PrEP Benefits
3mo, PrEP is affordable
|
10.0 units on a scale
|
9.67 units on a scale
Standard Deviation 0.58
|
|
PrEP Benefits
3mofu, PrEP can keep me from getting HIV
|
5.00 units on a scale
|
5.00 units on a scale
|
|
PrEP Benefits
3mofu, Using PrEP would make me feel more in charge of my life
|
5.00 units on a scale
|
5.00 units on a scale
|
|
PrEP Benefits
3mofu, I would be able to enjoy sex more if I was taking PrEP
|
5.00 units on a scale
|
10.00 units on a scale
|
|
PrEP Benefits
3mofu, PreP is easy to take
|
5.00 units on a scale
|
10.0 units on a scale
|
|
PrEP Benefits
3mofu, PrEP would not interfere with me injecting or taking drugs
|
10.0 units on a scale
|
—
|
|
PrEP Benefits
3mofu, I would not have to rely on my partner to use condoms if I was taking PrEP
|
10.0 units on a scale
|
5.0 units on a scale
|
|
PrEP Benefits
3mofu, I would only have to take one pill a day if I Was on PrEP
|
10.0 units on a scale
|
10.0 units on a scale
|
|
PrEP Benefits
3mofu, PrEP would let me worry less about HIV
|
10.0 units on a scale
|
10.0 units on a scale
|
|
PrEP Benefits
3mofu, I would not have to feel guilty about having fun if I took PrEP
|
10.0 units on a scale
|
7.00 units on a scale
|
|
PrEP Benefits
3mofu, PrEP is affordable
|
10.0 units on a scale
|
10.0 units on a scale
|
SECONDARY outcome
Timeframe: Three months, Three month post interventionPopulation: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
12 items assessed perceived barriers to taking PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.
Outcome measures
| Measure |
Enhanced Intervention
n=1 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=3 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
PrEP Barriers
3mo, It would be hard for me to take a pill every day
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, Taking PrEP would dull my high
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, Taking PrEP would cause too many side effects
|
0.00 units on a scale
|
2.00 units on a scale
Standard Deviation 3.46
|
|
PrEP Barriers
3mo, I feel healthy so I don't need to take PrEP
|
10.0 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, I already protect myself from HIV in other ways (condoms, not sharing needles)
|
10.0 units on a scale
|
5.33 units on a scale
Standard Deviation 3.51
|
|
PrEP Barriers
3mo, Even if I take PrEP, I might get HIV anyway
|
0.00 units on a scale
|
3.67 units on a scale
Standard Deviation 4.04
|
|
PrEP Barriers
3mo, PrEP only protects against HIV, not other sexually transmitted infections
|
10.0 units on a scale
|
10.0 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, My partner might hurt me if they knew I was on PrEP
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, I have a lot more worries in my life than getting HIV
|
10.0 units on a scale
|
9.00 units on a scale
Standard Deviation 1.73
|
|
PrEP Barriers
3mo, If i started PreP it would be hard to get to the doctor every 3 months
|
0.00 units on a scale
|
0.33 units on a scale
Standard Deviation 0.58
|
|
PrEP Barriers
3mo, I don't have a safe place to keep PrEP
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mo, I would be afraid if I had PrEP it would get stolen
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Barriers
3mofu, It would be hard for me to take a pill every day
|
5.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, Taking PrEP would dull my high
|
5.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, Taking PrEP would cause too many side effects
|
8.00 units on a scale
|
6.00 units on a scale
|
|
PrEP Barriers
3mofu, I feel healthy so I don't need to take PrEP
|
2.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, I already protect myself from HIV in other ways (condoms, not sharing needles)
|
10.0 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, Even if I take PrEP, I might get HIV anyway
|
10.0 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, PrEP only protects against HIV, not other sexually transmitted infections
|
10.0 units on a scale
|
10.0 units on a scale
|
|
PrEP Barriers
3mofu, My partner might hurt me if they knew I was on PrEP
|
0.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, I have a lot more worries in my life than getting HIV
|
5.00 units on a scale
|
5.00 units on a scale
|
|
PrEP Barriers
3mofu, If i started PreP it would be hard to get to the doctor every three months
|
5.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, I don't have a safe place to keep PrEP
|
0.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Barriers
3mofu, I would be afraid if I had PrEP it would get stolen
|
0.00 units on a scale
|
0.00 units on a scale
|
SECONDARY outcome
Timeframe: Three month, Three month post interventionPopulation: Enhanced group at 3 month (n=1) differs from the overall enhanced group n (17) \& basic group at 3 month (n=3) differs from overall basic group n (14) due to implementation barriers that prevented PrEP uptake (e.g., lack of venous access, not returning for doctor appointment), and remaining PrEP adherent (failure to pick up meds, failure to show for appointments). Drop off at 3 month is due to lost to follow up \& dropout.
9 items assessed perceived beliefs about PrEP. Items are asked on a 0-10 Likert, with 0 = strongly disagree, 5 = unsure, 10 = strongly agree. Thus, higher score indicates greater agreement with that item.
Outcome measures
| Measure |
Enhanced Intervention
n=1 Participants
Women who are eligible and randomized to the Enhanced Intervention will receive targeted PrEP counseling; targeted written/visual materials, follow up supportive text messages, and distribution of PrEP at the syringe exchange
Enhanced Intervention: Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
|
Basic Intervention
n=3 Participants
Women who are eligible and randomized to the Basic Intervention will receive "usual care" with general messaging from medical personnel, reminder text messages, and distribution of PrEP at the syringe exchange
Basic Intervention: General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
|
|---|---|---|
|
PrEP Beliefs
3mo, Sex workers need PrEP more than other people
|
0.00 units on a scale
|
0.67 units on a scale
Standard Deviation 1.16
|
|
PrEP Beliefs
3mo, People who inject drugs need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, Gay men need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, Trans people need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, People from certain races/ethnicities need PrEP more than other people
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, PrEP sounds too good to be true
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, PrEP makes people think they are invincible (can't get HIV or other sexually transmitted infect
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mo, PrEP is safe and effective for women to use
|
10.0 units on a scale
|
9.67 units on a scale
Standard Deviation 0.58
|
|
PrEP Beliefs
3mo, I am more likely to take PrEP if I am being paid to take it
|
0.00 units on a scale
|
0.00 units on a scale
Standard Deviation 0.00
|
|
PrEP Beliefs
3mofu, Sex workers need PrEP more than other people
|
10.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, People who inject drugs need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, Gay men need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, Trans people need PrEP more than other people
|
10.0 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, People from certain races/ethnicities need PrEP more than other people
|
10.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, PrEP sounds too good to be true
|
0.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, PrEP makes people think they are invincible (can't get HIV or other STIs)
|
0.00 units on a scale
|
0.00 units on a scale
|
|
PrEP Beliefs
3mofu, PrEP is safe and effective for women to use
|
10.0 units on a scale
|
10.0 units on a scale
|
|
PrEP Beliefs
3mofu, I am more likely to take PrEP if I am being paid to take it
|
0.00 units on a scale
|
0.00 units on a scale
|
Adverse Events
Enhanced Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Basic Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place