Improving PrEP Access and Adherence for Male Sex Workers
Efficacy of a PrEP Uptake & Adherence Intervention Among Male Sex Workers Using a 2-stage Randomization Design
NA · Brown University · NCT05736614
This study is testing a new way to help male sex workers start and stick with PrEP to prevent HIV by using support from peers and technology.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Brown University (other) |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT05736614 on ClinicalTrials.gov |
What this trial studies
This clinical trial, titled 'PrEPare for Work', aims to enhance the uptake and adherence to PrEP among male sex workers through a randomized controlled trial. The intervention consists of two components: peer-led case management to facilitate PrEP access and a technology-based counseling approach to support ongoing adherence. By addressing specific barriers faced by this population, the study seeks to evaluate the effectiveness and cost-efficiency of these tailored interventions. Participants will be monitored for their engagement with PrEP over time to assess the overall impact of the program.
Who should consider this trial
Good fit: Ideal candidates for this study are male individuals aged 18 and older who have engaged in condomless anal sex and exchanged sex for compensation within the last three months.
Not a fit: Patients who are currently on PrEP or have active health issues that prevent PrEP initiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly increase PrEP uptake and adherence among male sex workers, leading to reduced HIV transmission rates.
How similar studies have performed: Other studies have shown promise in using tailored interventions to improve PrEP uptake in high-risk populations, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Los Angeles, California and 4 other locations
- UCLA Fielding School of Public Health — Los Angeles, California, United States (RECRUITING)
- The Miriam Hospital — Providence, Rhode Island, United States (RECRUITING)
- Open Door Health — Providence, Rhode Island, United States (RECRUITING)
- Project Weber/RENEW — Providence, Rhode Island, United States (RECRUITING)
- Brown University School of Public Health — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Katie Biello, PhD — Brown University School of Public Health
- Study coordinator: Katie Biello, PhD
- Email: Katie_Biello@brown.edu
- Phone: 401-863-3082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prevention, PrEP, Male Sex Workers