Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Study Overview
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Brief Summary
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PrEPare for Work is a randomized controlled trial (RCT) whose goal is to test the efficacy of a behavioral intervention (Short Title: PrEPare for Work) in improving PrEP uptake, adherence, and persistence among male sex workers (MSW)

Detailed Description
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A theory-based, manualized intervention -called PrEPare for Work-includes two separate but complementary interventions that address MSW-specific behavioral, economic, interpersonal & structural-level barriers to accessing and adhering to PrEP: 1) peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake; and 2) a technology and counseling intervention to optimize PrEP adherence (once they have access to PrEP). This research will test the PrEPare for Work intervention in a fully-powered RCT to assess efficacy and cost-effectiveness.

Official Title
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Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design

Conditions
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Prevention

Intervention / Treatment
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* Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition
* Behavioral: Stage 2 PrEPare for Work Intervention Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Age: 18 years or older Assigned male sex at birth Identifies as male at enrollment Report having engaged in condomless anal sex with another man in the past 3 months Report having exchanged sex for money, drugs, items of value, or a place to stay with another man in the past 3 months Report HIV status as negative or unsure Not currently on PrEP Able to understand and speak English or Spanish Exclusion Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of interview (will use an adapted version of the Evaluation to Sign Consent Form65 to assess capacity) Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment) Laboratory or clinical findings that would preclude PrEP initiation (e.g. Chronic Hepatitis B Virus infection, decreased creatinine clearance) Participated in the pilot RCT and initiated PrEP during study participation

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: Randomized Controlled Trial (RCT) Study arms: Stage 1 Standard of Care (SOC) Control Condition Stage 1 Strength Based Case Management (SBCM) Condition Stage 2 SOC Control Condition Stage 2 PrEPare for Work Intervention Condition
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Stage 1 Standard of Care (SOC) Control Condition<br>SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers. | |
| Experimental: Stage 1 Strength Based Case Management (SBCM) Condition<br>Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment. | Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition<br>* Intervention participants will receive a trained SBCM to motivate, support, and assist in linkage to PrEP prescribers to help facilitate obtaining PrEP medication to initiate treatment.<br>|
| No Intervention: Stage 2 SOC Control Condition<br>Research staff will show a brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission. Participants will continue to see their PrEP prescriber for routine clinical care. | |
| Experimental: Stage 2 PrEPare for Work Intervention Condition<br>Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist. | Behavioral: Stage 2 PrEPare for Work Intervention Condition<br>* Intervention participants will receive 1-on-1 adherence counseling and personalized daily text messaging reminders to increase PrEP adherence. Intervention participants will undergo three adherence intervention sessions (once per week for 3 weeks) with interventionist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage one: PrEP initiation | Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report. | 2-month post Stage 1 randomization | 
| Stage two: PrEP adherence | Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals. | 12-month post Stage 2 randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP persistence | PrEP persistence will be measured via medical records and self-report. We will assess PrEP persistence using medical and pharmacy records to confirm provider follow-up visits and prescription refill maintenance. As per Coy et al., PrEP persistence will be defined as having ≥16 days of PrEP medication filled per 30-day period, for at least three-quarters of the months since initiation to study completion ( 9 months). | 12-month 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)