Peer-driven Intervention on PrEP

Lifespan

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Peer-driven intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05161663

1594759

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 98 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria 18 years of age or older Assigned male at birth and currently identify as male Having sex with men in the past three months Not currently on PrEP English- or Spanish-speaking

Exclusion Criteria:

Age less than 18 years, No having sex with men in the past 3 months

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

98 participants in 2 patient groups

PDI group

Experimental group

Description:

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.

Treatment:

Behavioral: Peer-driven intervention

Control group

No Intervention group

Description:

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.