An interventional study of Peer-driven intervention in HIV Infections, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Prevention
The objective of this study is to develop an effective peer-driven intervention (PDI) approach and assess its feasibility and efficacy on pre-exposure prophylaxis (PrEP) uptake among men who have sex with men.
This proposed study aims to assess the effect of a peer-driven intervention (PDI) on promoting pre-exposure prophylaxis (PrEP) uptake among African American (AA) and Hispanic/Latino men who have sex with men (MSM). PDI is based on respondent-driven sampling (RDS) or snowball sampling. PDI is a chain referral approach and includes both peer referral and peer education. Index peers will be purposefully sampled to reflect the diversity of our study population through local clinics, community organizations, and online. Index peers will receive a four-hour formal training about PrEP and HIV, educate members of their social network, and encourage them to initiate PrEP. Each index peers will be given three referral coupons. Referred peers will schedule a research visit to complete a short survey and then be referred to the local PrEP clinic if they are interested in starting PrEP. These referred individuals will also serve as index peers for the following wave of recruitment. We expect to achieve a robust sample of AA and H/L MSM within six waves of recruitment as peers will educate and recruit study participants through their social networks.
Given the nature of RDS, the study design will include a concurrent non-randomized control group, which will be recruited using venue-based sampling (e.g. gay dance clubs, bars, and social organizations). This has been used in previous RDS studies as an appropriate study design and comparison group. We will identify appropriate venues that AA and H/L MSM frequent using one-to-one qualitative interviews in Specific Aim 1. Research staff will visit these venues at specific times to recruit AA and H/L MSM. MSM who are willing to participate in this study will receive PrEP and HIV education offered by research staff and complete a short survey during outreach. Individuals who are interested in PrEP uptake will be referred to the PrEP clinic. All study participants, regardless of PrEP status (initiated or not initiated), will be followed for six months. Each individual will complete three visits, including baseline, three-month, and six-month follow-ups.
This study has two independent arms. Our primary outcome is PrEP uptake, which is defined as a binary variable (Yes vs. No). We will calculate the study power using the method for two independent proportions power analyses. Our local STD clinic data shows only 8% of AA and H/L MSM have used PrEP and we will assume that 8% of AA and H/L MSM recruited through venue-based sampling will initiate PrEP. We expect to observe at least a 14% increase in PrEP uptake in the PDI group. To have 80% of power (Type I error =0.05), we will recruit 100 participants (N=100, 50 AA, and 50 H/L MSM) in each group.
PrEP uptake measured by receiving a prescription for the medication and filling a prescription at a pharmacy will be treated as time-to-event variables. We will perform survival analysis techniques (Kaplan-Meier models and Cox proportional hazards models) to assess the effect of the PDI on PrEP initiation. Self-reported PrEP adherence and drug concentration level (Yes vs. No) will be treated as binary variables and multivariate logistic regression will be performed.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 98 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →The Miriam Hospital is the lead sponsor of 178 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible for this study, participants must meet the following requirements:
Age: 18 years of age or older. Gender/Sex: Assigned male at birth and currently identify as male. Sexual Orientation/Behavior: Having sex with men in the past three months. PrEP Status: Not currently on PrEP (Pre-Exposure Prophylaxis). Language: English- or Spanish-speaking.
Exclusion Criteria
Individuals meeting any of the following will be excluded:
Age: Less than 18 years of age. Sexual Behavior: No history of having sex with men in the past three months.
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.
Behavioral: Peer-driven intervention
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.
This peer-driven intervention (PDI), modified based on respondent-driven sampling (RDS) or snowball sampling, is a "chain referral" approach. Index peers will be purposefully selected to reflect the diversity of African American (AA) and Hispanic/Latino (H/L) men who have sex with men (MSM) and are required to take a formal training about pre-exposure prophylaxis (PrEP) and HIV. These index peers will educate members of their social networks and encourage them to initiate PrEP. Those referred peers will schedule an appointment to complete a short survey and will be referred to our PrEP clinic if they are interested in PrEP uptake. The referred peers will serve as index peers for the following wave of recruitment. It is expected to achieve a robust sample of AA and H/L within six waves of recruitment. This PDI approach is potential to engage AA and H/L who are most at risk of HIV acquisition in PrEP uptake and could contribute to reducing the concentrated HIV epidemic.
Pre-exposure Prophylaxis (PrEP) Uptake
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?
Time frame: 0-6 months
Number of Participants With PrEP Persistence
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.
Time frame: 0-6 months
Pre-exposure Prophylaxis (PrEP) Adherence
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.
Time frame: 30 days prior to 6-month follow-up visit
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.
| Milestone | PDI Group | Control Group | Peer Educator |
|---|---|---|---|
| Started | 13 | 46 | 39 |
| Completed | 13 | 46 | 39 |
| Not completed | 0 | 0 | 0 |
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?
| Participants | PDI Group | Control Group |
|---|---|---|
| Pre-exposure Prophylaxis (PrEP) Uptake | 5 | 13 |
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.
| Participants | PDI Group | Control Group |
|---|---|---|
| Number of Participants With PrEP Persistence | 4 | 12 |
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.
| Participants | PDI Group | Control Group |
|---|---|---|
| Pre-exposure Prophylaxis (PrEP) Adherence | 5 | 13 |
Collected over 0-6months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PDI Group | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Control Group | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Peer Educator | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
The baseline analysis population consists of two distinct groups: 13 peer-referred participants and 46 venue-based participants (Total N=59). Additionally, 39 Peer Educators were enrolled and trained to facilitate recruitment; however, these Peer Educators were already PrEP users at baseline and are analyzed separately from the primary PrEP-naive study population to avoid confounding the PrEP initiation outcomes.
| Age, Continuous(Years) | PDI Group | Control Group | Peer Educator | Total |
|---|---|---|---|---|
| Median | 24 (21 to 31) | 27 (23 to 34) | 30 (26 to 36) | 28 (24 to 35) |
| Sex/Gender, Customized(Participants) | PDI Group | Control Group | Peer Educator | Total |
|---|---|---|---|---|
| Male assigned at birth only | 13 | 46 | 39 | 98 |
| Race (NIH/OMB)(Participants) | PDI Group | Control Group | Peer Educator | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 |
| White | 11 | 36 | 28 | 75 |
| More than one race | 2 | 6 | 5 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | PDI Group | Control Group | Peer Educator | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 9 | 7 | 18 |
| Not Hispanic or Latino | 11 | 37 | 32 | 80 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| PrEP use at Baseline(Participants) | PDI Group | Control Group | Peer Educator | Total |
|---|---|---|---|---|
| Count of participants | 0 | 0 | 39 | 39 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not plan to share individual participant data due to confidentiality considerations and the sensitive nature of behavioral and HIV-related information collected.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Miriam Hospital