Optimizing PrEP Uptake and Adherence Among Male Sex Workers (P4W)

Brown University

Status: Enrolling

Conditions: Prevention

Treatments: Behavioral: Stage 2 PrEPare for Work Intervention Condition; Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05736614

R01NR020227 (U.S. NIH Grant/Contract)

2001002627

Details and patient eligibility

About

"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)

Full 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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 4 patient groups

Stage 1 Standard of Care (SOC) Control Condition

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition

Stage 2 SOC Control Condition

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: Stage 2 PrEPare for Work Intervention Condition