Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Prevention
- Sponsor
- Brown University
- Enrollment
- 500
- Locations
- 5
- Primary Endpoint
- Stage one: PrEP initiation
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stage one: PrEP initiation
Time Frame: 2-month post Stage 1 randomization
Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report.
Stage two: PrEP adherence
Time Frame: 12-month post Stage 2 randomization
Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.
Secondary Outcomes
- PrEP persistence(12-month post Stage 2 randomization)