A Peer-Driven Intervention to Increase PrEP Uptake Among Minority MSM

NCT05161663 | Completed Results

• 2 other identifiers: 15947591K01MH119960-01A1
• 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

  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?

  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.

  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.

  30 days prior to 6-month follow-up visit

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 qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 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

Limitations and Caveats

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.

Results Point of Contact

• Title: Jun Tao
• Organization: The Miriam Hospital

JTao@brownhealth.org

6157273962

Study Officials

• Jun Tao

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 1, 2022
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: May 19, 2026
• Results First Posted: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)