Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design

Not Applicable

Completed

• Conditions: Prevention

• Registration Number: NCT03086057
• Lead Sponsor: Brown University

Brief Summary

"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).

Detailed Description

The "PrEPare for Work" package includes two behavioral intervention components:

1. Strengths-based case management for PrEP initiation, and

2. Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.

Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.

Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.

Study Timeline

• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-21
• Study First Posted: 2017-03-22
• Study Start: 2017-05-01
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Status Verified: 2021-02
• Results First Submitted: 2021-02-03
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-15
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 111

Inclusion Criteria

• 18 years of age or older
• Biological male at birth and current male gender identity
• Exchanged sex for money or drugs with another man in the past 3 months
• Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
• HIV uninfected by antibody test* Stage 2
• Able to understand and speak English (for consent and counseling)
• Mental competency to provide voluntary informed consent
• Lives in the New England area
• Willing to initiate PrEP

Exclusion Criteria

• Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
• HIV Positive at baseline
• Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate < 50) *Stage 2
• History of or current medical conditions that would preclude taking Truvada for PrEP *Stage 2
• Currently taking Truvada for PrEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic	2-month post Stage 1 randomization	Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records
Number of Participants Who Initiated PrEP	2-month post Stage 1 randomization	Initial prescription from provider filled and shown to study staff
Number of Participants Reporting Optimal PrEP Adherence	6-months post Stage 2 randomization	Self-reporting missing 0 PrEP pills in the past week

Trial Locations

Locations (2)

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

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