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.

Inclusion Criteria

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.

We do not plan to share individual participant data due to confidentiality considerations and the sensitive nature of behavioral and HIV-related information collected.

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.

0-6months

Adverse events were monitored throughout the study period via self-report during follow-up assessments at 3 and 6 months. As this was a behavioral intervention focused on PrEP counseling and peer-referral, adverse events were defined as any untoward psychological or social occurrence related to study participation. Clinical side effects related to PrEP medication itself were managed by the participants' primary prescribing clinicians and are not reported as study-related adverse events.

Limitations include a small sample size and non-randomized design, which may limit the generalizability of findings and the ability to establish definitive causality. The study relied on self-reported data for PrEP initiation and adherence, which is subject to social desirability bias. Additionally, the short 6-month follow-up period may not capture long-term PrEP persistence. Most participants were recruited in one geographic area, potentially limiting broader applicability.

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