Optimizing PrEP Uptake and Adherence Among Male Sex Workers

Prevention Clinical Trial

— P4W  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736614
• Other study ID #: 2001002627
• Secondary ID: R01NR020227
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Brown University
• Contact: Katie Biello, PhD
• Phone: 401-863-3082
• Email: Katie_Biello[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prevention

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	UCLA Fielding School of Public Health	Los Angeles	California
United States	Brown University School of Public Health	Providence	Rhode Island
United States	Open Door Health	Providence	Rhode Island
United States	Project Weber/RENEW	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage one: PrEP initiation	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-month post Stage 1 randomization
Primary	Stage two: PrEP adherence	Stage two: PrEP adherence will be measured via tenofovir concentration in hair. Self-reported adherence will supplement biological monitoring data at 4-month intervals.	12-month post Stage 2 randomization
Secondary	PrEP persistence	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).	12-month post Stage 2 randomization