Back to Trials
NCT05736614NARecruitingAccepts Healthy Volunteers

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Brown University

Start Date

11/3/2022

Completion Date

6/1/2026

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)

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Stage 1 Strength Based Case Management (SBCM) Condition

BEHAVIORAL

Stage 2 PrEPare for Work Intervention Condition

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Prevention

Locations

UCLA Fielding School of Public Health

Los Angeles, California 90095

United States

The Miriam Hospital

Providence, Rhode Island 02906

United States

Open Door Health

Providence, Rhode Island 02907

United States

Project Weber/RENEW

Providence, Rhode Island 02907

United States

Brown University School of Public Health

Providence, Rhode Island 02912

United States