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

Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design

"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.

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