Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
Healthy Volunteers
NCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Led by Brown University · Updated on 2025-05-09

500

Participants Needed

5

Research Sites

186 weeks

Total Duration

On this page

Sponsors

B

Brown University

Lead Sponsor

T

The Miriam Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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)

CONDITIONS

Official Title

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 5 locations

1

UCLA Fielding School of Public Health

Los Angeles, California, United States, 90095

Actively Recruiting

2

The Miriam Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

3

Open Door Health

Providence, Rhode Island, United States, 02907

Actively Recruiting

4

Project Weber/RENEW

Providence, Rhode Island, United States, 02907

Actively Recruiting

5

Brown University School of Public Health

Providence, Rhode Island, United States, 02912

Actively Recruiting

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Research Team

K

Katie Biello, PhD

CONTACT

M

Matthew Mimiaga, ScD MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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