Peer-driven Intervention on PrEP

NCT05161663 | Completed

• 1 other identifier: 1594759
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Keywords

pre-exposure prophylaxis

Outcome Measures

Primary Outcomes (3)

• Pre-exposure prophylaxis (PrEP) uptake

  Self-report PrEP uptake

  0-6 months

• Pre-exposure prophylaxis (PrEP) persistence

  the length of time on PrEP

  0-6 months

• Pre-exposure prophylaxis (PrEP) adherence

  Self-reported medication adherence

  0-6 months

Study Arms (2)

PDI group

EXPERIMENTAL

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

Control group

NO 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.

Interventions

Peer-driven intervention BEHAVIORAL

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.

PDI group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Rhode Island Public Health Institute: collaborator
• National Institute of Mental Health (NIMH): collaborator
• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No mask
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: December 17, 2021
• Study Start: January 6, 2022
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)