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

Study Overview
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Brief Summary
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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
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The PrEPare for Work package includes two behavioral intervention components: Strengths-based case management for PrEP initiation, and 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.

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

Conditions
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Prevention

Intervention / Treatment
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* Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1)
* Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength Based Case Management<br>Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications. | Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1)<br>* Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.<br>|
| Experimental: PrEP adherence training and counseling<br>Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist. | Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2)<br>* Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.<br>|
| No Intervention: Standard of Care:Stage 1<br>Stage 1: Referral to The Miriam Hospital PrEP Clinic. | |
| No Intervention: Standard of Care: Stage 2<br>Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2-month post Stage 1 randomization | 
| Number of Participants Who Initiated PrEP | Initial prescription from provider filled and shown to study staff | 2-month post Stage 1 randomization | 
| Number of Participants Reporting Optimal PrEP Adherence | Self-reporting missing 0 PrEP pills in the past week | 6-months post Stage 2 randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PrEP, Prevention, Male Sex Workers (MSW)