RecruitingNot ApplicableNCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

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

Sponsor

Brown University

Enrollment

500 participants

Start Date

Nov 3, 2022

Study Type

INTERVENTIONAL

Conditions

Prevention

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)

Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria4

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

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Interventions

BEHAVIORALStage 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.

BEHAVIORALStage 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.