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

Age Range:18 - Any
Start Date:May 1, 2017
End Date:April 2020
Contact:Matthew J Mimiaga, ScD, MPH
Phone:401 863-6559

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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
We found this trial at
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Phone: 401-793-2928
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
Providence, RI
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Providence, Rhode Island 02912
Phone: 401-863-3292
Providence, RI
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