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NCT Number: NCT05736614

Optimizing PrEP Uptake and Adherence Among Male Sex Workers

"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)

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Key information

Conditions

Prevention

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Fielding School of Public Health, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stage 1 Strength Based Case Management (SBCM) Condition

Behavioral

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

Behavioral

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 outcomes

  1. Stage one: PrEP initiation

    Time frame: 2-month post Stage 1 randomization

    Stage one: PrEP initiation will be measured via verification of prescription filled within two months post-randomization, associated medical records from a PrEP prescriber, and self-report.

  2. Stage two: PrEP adherence

    Time frame: 12-month post Stage 2 randomization

    Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.

Secondary outcomes

  1. PrEP persistence

    Time frame: 12-month post Stage 2 randomization

    PrEP persistence will be measured via medical records and self-report. We will assess PrEP persistence using medical and pharmacy records to confirm provider follow-up visits and prescription refill maintenance. As per Coy et al., PrEP persistence will be defined as having ≥16 days of PrEP medication filled per 30-day period, for at least three-quarters of the months since initiation to study completion (~9 months).

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Biello, PhD

CONTACT

[email protected]

401-863-3082

Matthew Mimiaga, ScD MPH

CONTACT

[email protected]

617 901 9276

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • Open Door Health
  • Project Weber/RENEW
  • The Miriam Hospital
  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: P4W

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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