Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
500 (estimated)
Sponsor
Brown University · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStage 1 Strength Based Case Management (SBCM) ConditionIntervention 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.
BEHAVIORALStage 2 PrEPare for Work Intervention ConditionIntervention 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.

Timeline

Start date
2022-11-03
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2023-02-21
Last updated
2025-05-09

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05736614. Inclusion in this directory is not an endorsement.