Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brown University
- Enrollment
- 500
- Locations
- 5
- Primary Endpoint
- Stage one: PrEP initiation
Study Overview
Brief Summary
"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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Stage 1 Standard of Care (SOC) Control Condition
SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.
Stage 1 Strength Based Case Management (SBCM) Condition
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.
Intervention: Stage 1 Strength Based Case Management (SBCM) Condition (Behavioral)
Stage 2 SOC Control Condition
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.
Stage 2 PrEPare for Work Intervention Condition
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.
Intervention: Stage 2 PrEPare for Work Intervention Condition (Behavioral)
Outcomes
Primary Outcomes
Stage one: PrEP initiation
Time Frame: 2-month post Stage 1 randomization
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.
Stage two: PrEP adherence
Time Frame: 12-month post Stage 2 randomization
Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.
Secondary Outcomes
- PrEP persistence(12-month post Stage 2 randomization)