Trial Outcomes & Findings for A Peer-Driven Intervention to Increase PrEP Uptake Among Minority MSM (NCT NCT05161663)
NCT ID: NCT05161663
Last Updated: 2026-05-19
Results Overview
Participant self-report of having initiated PrEP medication at any point between the baseline visit and the 6-month follow-up. Data represent the number of participants who provided a 'Yes' response to the assessment question: 'Have you started taking PrEP since your last visit?
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
0-6 months
Results posted on
2026-05-19
Participant Flow
Recruitment Period Dates: July 2022 - September 2024. Recruitment Methods The study used a two-arm recruitment strategy: Venue-Based (Control): In-person recruitment at an outpatient STI clinic in Rhode Island. Outreach at LGBTQ+ nightlife venues (bars, clubs) and a university LGBTQ+ center. Distribution of flyers and coasters with QR codes. Peer-Driven Intervention (PDI): Peer Educators recruited members of their social networks. Five electronic referral cards per peer educator.
No significant events or deviations occurred between enrollment and group assignment; all participants proceeded directly to baseline assessments and standardized PrEP counseling as per protocol.
Participant milestones
| Measure |
PDI Group
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
|
Control Group
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
|
Peer Educator
Peer Educators attended a 1-hour virtual health education session 1 .
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
46
|
39
|
|
Overall Study
COMPLETED
|
13
|
46
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender identity was self-reported by participants during the baseline assessment. Per the study's eligibility criteria, all participants were required to be assigned male at birth.
Baseline characteristics by cohort
| Measure |
PDI Group
n=13 Participants
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
|
Control Group
n=46 Participants
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
|
Peer Educator
n=39 Participants
Peer Educators attended a 1-hour virtual health education session 1 .
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24 Years
n=30 Participants
|
27 Years
n=30 Participants
|
30 Years
n=60 Participants
|
28 Years
n=133 Participants
|
|
Sex/Gender, Customized
Male assigned at birth only
|
13 Participants
n=30 Participants • Gender identity was self-reported by participants during the baseline assessment. Per the study's eligibility criteria, all participants were required to be assigned male at birth.
|
46 Participants
n=30 Participants • Gender identity was self-reported by participants during the baseline assessment. Per the study's eligibility criteria, all participants were required to be assigned male at birth.
|
39 Participants
n=60 Participants • Gender identity was self-reported by participants during the baseline assessment. Per the study's eligibility criteria, all participants were required to be assigned male at birth.
|
98 Participants
n=133 Participants • Gender identity was self-reported by participants during the baseline assessment. Per the study's eligibility criteria, all participants were required to be assigned male at birth.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
3 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
5 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
8 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
1 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
1 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
2 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
White
|
11 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
36 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
28 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
75 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
6 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
5 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
13 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
0 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided race information at baseline. The numbers reported in each category reflect the total count for each arm. In cases where participants identified with multiple races, they are counted within the 'More than one race' category to ensure the total count matches the number of participants assigned to each arm.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
9 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
7 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
18 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
37 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
32 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
80 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
0 Participants
n=30 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
0 Participants
n=60 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
0 Participants
n=133 Participants • The analysis population includes all 59 PrEP-naive participants and 39 Peer Educators who provided ethnicity information at baseline. The numbers reported reflect the total count for each arm. There were no missing data points for ethnicity; therefore, the analysis population matches the total number of participants assigned to each group.
|
|
PrEP use at Baseline
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
39 Participants
n=60 Participants
|
39 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 0-6 monthsPopulation: The analysis population for the primary outcome includes only those participants who were PrEP-naive at baseline (N=59). Peer Educators (n=39) are excluded from this analysis as they were already utilizing PrEP at the time of enrollment and therefore could not meet the criteria for 'PrEP uptake.' The numbers reported for the PDI and Control groups represent all participants assigned to those arms who provided follow-up data regarding their PrEP status.
Participant self-report of having initiated PrEP medication at any point between the baseline visit and the 6-month follow-up. Data represent the number of participants who provided a 'Yes' response to the assessment question: 'Have you started taking PrEP since your last visit?
Outcome measures
| Measure |
PDI Group
n=13 Participants
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
|
Control Group
n=46 Participants
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
|
|---|---|---|
|
Pre-exposure Prophylaxis (PrEP) Uptake
|
5 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: 0-6 monthsPopulation: The analysis population includes the 59 PrEP-naive participants assigned to the PDI (n=13) and Control (n=46) groups. Peer Educators are excluded from this analysis as they were already on PrEP at baseline. The number of participants analyzed reflects those who initiated PrEP and provided follow-up data at both the 3 and 6-month time points. Any reduction in the number of participants from the total assigned to each arm is due to loss to follow-up or failure to initiate PrEP.
The number of participants who remained on PrEP medication without a gap of more than 30 days throughout the 6-month study period, as reported during follow-up interviews.
Outcome measures
| Measure |
PDI Group
n=5 Participants
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
|
Control Group
n=13 Participants
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
|
|---|---|---|
|
Number of Participants With PrEP Persistence
|
4 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 30 days prior to 6-month follow-up visitPopulation: The analysis population for this measure is restricted to the subset of participants who initiated PrEP (n=18 total; 5 in the PDI group and 13 in the Control group). Peer Educators and participants who did not start PrEP are excluded. The difference between the numbers reported here and the total assigned to each arm in the Participant Flow represents those individuals who did not initiate PrEP during the 6-month study period.
Participant adherence to the prescribed PrEP regimen over the 30 days prior to the 6-month follow-up visit, measured via self-report. Adherence was calculated based on the frequency of doses taken per week. Participants were considered adherent if they reported taking at least 4 pills per week, which is the threshold associated with high levels of protection against HIV acquisition.
Outcome measures
| Measure |
PDI Group
n=5 Participants
In this group, participants will receive education about HIV and pre-exposure prophylaxis (PrEP) and be referred to our study by peer educators. Referred participants will have free PrEP counseling and receive referrals if interested. We will follow up at three and six months and check participants' PrEP status.
|
Control Group
n=13 Participants
In the control group, participants do not receive any education from peers and will be directly recruited by research assistants from venues (e.g. gay bars, LGBTQ communities, LGBTQ events, and social media advertisements). Participants will receive PrEP counseling and referral if interested. We will follow up at three and six months and check participants' PrEP status.
|
|---|---|---|
|
Pre-exposure Prophylaxis (PrEP) Adherence
|
5 Participants
|
13 Participants
|
Adverse Events
PDI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peer Educator
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