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

Brown University111 enrolled

Overview

"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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

111

Conditions

Prevention

Interventions

PrEPare for Work: Strength Based Case Management (Stage 1)BEHAVIORAL

Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.

PrEPare for Work: Adherence Training and Counseling (Stage 2)BEHAVIORAL

Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

The Miriam Hospital

Providence, Rhode Island, United States

Brown University School of Public Health

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic

Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records

Time frame: 2-month post Stage 1 randomization

Number of Participants Who Initiated PrEP

Initial prescription from provider filled and shown to study staff

Time frame: 2-month post Stage 1 randomization

Number of Participants Reporting Optimal PrEP Adherence

Self-reporting missing 0 PrEP pills in the past week

Time frame: 6-months post Stage 2 randomization

Data from ClinicalTrials.gov

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