Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Not Applicable

Recruiting

• Conditions: Prevention
• Interventions: Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition; Behavioral: Stage 2 PrEPare for Work Intervention Condition

• Registration Number: NCT05736614
• Lead Sponsor: Brown University

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.

Study Timeline

• Study Start: 2022-11-03
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1 Strength Based Case Management (SBCM) Condition	Stage 1 Strength Based Case Management (SBCM) Condition	Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.
Stage 2 PrEPare for Work Intervention Condition	Stage 2 PrEPare for Work Intervention Condition	Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.

Primary Outcome Measures

Name	Time	Method
Stage one: PrEP initiation	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	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 Outcome Measures

Name	Time	Method
PrEP persistence	12-month post Stage 2 randomization	PrEP persistence will be measured via medical records and self-report. We will assess PrEP persistence using medical and pharmacy records to confirm provider follow-up visits and prescription refill maintenance. As per Coy et al., PrEP persistence will be defined as having ≥16 days of PrEP medication filled per 30-day period, for at least three-quarters of the months since initiation to study completion (\~9 months).

Trial Locations

Locations (5)

UCLA Fielding School of Public Health; 🇺🇸 Los Angeles, California, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Open Door Health; 🇺🇸 Providence, Rhode Island, United States

Project Weber/RENEW; 🇺🇸 Providence, Rhode Island, United States

Brown University School of Public Health; 🇺🇸 Providence, Rhode Island, United States