Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Last updated: May 6, 2025
Sponsor: Brown University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Stage 2 PrEPare for Work Intervention Condition

Stage 1 Strength Based Case Management (SBCM) Condition

Clinical Study ID

NCT05736614
2001002627
R01NR020227
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study Summary

"PrEPare for Work" is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

Eligibility Criteria

Inclusion

Inclusion

  • Age: 18 years or older

  • Assigned male sex at birth

  • Identifies as male at enrollment

  • Report having engaged in condomless anal sex with another man in the past 3 months

  • Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months

  • Report HIV status as negative or unsure

  • Not currently on PrEP

  • Able to understand and speak English or Spanish

Exclusion

  • Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity)

  • Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment)

  • Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance)

  • Participated in the pilot RCT and initiated PrEP during study participation

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Stage 2 PrEPare for Work Intervention Condition
Phase:
Study Start date:
November 03, 2022
Estimated Completion Date:
June 30, 2026

Study Description

A theory-based, manualized intervention -called "PrEPare for Work"-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal & structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.

Connect with a study center

  • UCLA Fielding School of Public Health

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Brown University School of Public Health

    Providence, Rhode Island 02912
    United States

    Active - Recruiting

  • Open Door Health

    Providence, Rhode Island 02907
    United States

    Active - Recruiting

  • Project Weber/RENEW

    Providence, Rhode Island 02907
    United States

    Active - Recruiting

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Active - Recruiting

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