Recruiting

PrEP

Sponsor:

Brown University

Code:

NCT05736614

Conditions

Prevention

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Stage 1 Strength Based Case Management (SBCM) Condition

Stage 2 PrEPare for Work Intervention Condition

Study Details

Brief 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)

Conditions

Prevention

Study ID

NCT05736614

Start date

Nov 3, 2022

Status verified date

May, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Stage 1 Standard of Care (SOC) Control Condition

SOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.

experimental: Stage 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.

no intervention: Stage 2 SOC Control Condition

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.

experimental: Stage 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.

Interventions

Stage 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.

Stage 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.

Primary outcome measure

  • Stage one: PrEP initiation [ Time Frame: 2-month post Stage 1 randomization ]
  • Stage two: PrEP adherence [ Time Frame: 12-month post Stage 2 randomization ]

Central Contacts and Locations

Central contacts

Katie Biello, PhD

401-863-3082Katie_Biello@brown.edu

Matthew Mimiaga, ScD MPH

617 901 9276mmimiaga@ph.ucla.edu

Locations

UCLA Fielding School of Public Health

Recruiting

Los Angeles, California, United States, 90095

Contacts

Eun Kwak

ekwak@ph.ucla.edu

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

Philip A Chan, MD

401-793-2928philip_chan@brown.edu

Open Door Health

Recruiting

Providence, Rhode Island, United States, 02907

Contacts

Philip Chan, MD

1-401-648-4700philip_chan@brown.edu

Project Weber/RENEW

Recruiting

Providence, Rhode Island, United States, 02907

Contacts

Colleen Daley Ndoye

(401) 383-4888cdn@weberrenew.org

Brown University School of Public Health

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Vanessa Silva

6178988486Vanessa Silva <vanessa_silva@brown.edu>

Katie Biello, PhD

401 863 3082Katie_Biello@brown.edu

More Information

Sponsor

Brown University

Last update posted

May 9, 2025

Last verified

May, 2025

Keywords

  • PrEP
  • Prevention
  • Male Sex Workers (MSW)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brown University on 2025-05-09.