Optimizing PrEP Uptake and Adherence Among Male Sex Workers

a study on PrEP

Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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)

Official Title

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

Details

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.

Keywords

Prevention, PrEP, Male Sex Workers (MSW), Stage 1 Strength Based Case Management (SBCM) Condition, Stage 2 PrEPare for Work Intervention Condition

Eligibility

For males ages 18 years and up

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

Locations

  • UCLA Fielding School of Public Health accepting new patients
    Los Angeles California 90095 United States
  • Open Door Health accepting new patients
    Providence Rhode Island 02907 United States
  • Project Weber/RENEW accepting new patients
    Providence Rhode Island 02907 United States
  • The Miriam Hospital accepting new patients
    Providence Rhode Island 02906 United States
  • Brown University School of Public Health accepting new patients
    Providence Rhode Island 02912 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Brown University
ID
NCT05736614
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated