Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | May 1, 2017 |
End Date: | April 2020 |
Contact: | Matthew J Mimiaga, ScD, MPH |
Email: | matthew_mimiaga@brown.edu |
Phone: | 401 863-6559 |
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).
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.
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
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