Optimizing PrEP Uptake and Adherence Among Male Sex Workers (P4W)

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

"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)

Study Overview

• Status: Recruiting
• Conditions: Prevention
• Intervention / Treatment: Behavioral: Stage 1 Strength Based Case Management (SBCM) Condition; Behavioral: Stage 2 PrEPare for Work Intervention Condition

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Biello, PhD; Phone Number: 401-863-3082; Email: Katie_Biello@brown.edu
• Study Contact Backup: Name: Matthew Mimiaga, ScD MPH; Phone Number: 617 901 9276; Email: mmimiaga@ph.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Fielding School of Public Health
      • Contact: Eun Kwak; Email: ekwak@ph.ucla.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • The Miriam Hospital
      • Contact: Philip A Chan, MD; Phone Number: 401-793-2928; Email: philip_chan@brown.edu
    • Providence, Rhode Island, United States, 02912
      • Recruiting
      • Brown University School of Public Health
      • Contact: Vanessa Silva; Phone Number: 617-898-8486; Email: Vanessa Silva <vanessa_silva@brown.edu>
      • Contact: Katie Biello, PhD; Phone Number: 401 863 3082; Email: Katie_Biello@brown.edu
    • Providence, Rhode Island, United States, 02907
      • Recruiting
      • Open Door Health
      • Contact: Philip Chan, MD; Phone Number: 401-648-4700; Email: philip_chan@brown.edu
    • Providence, Rhode Island, United States, 02907
      • Recruiting
      • Project Weber/RENEW
      • Contact: Colleen Daley Ndoye; Phone Number: 401-383-4888; Email: cdn@weberrenew.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: University of California, Los Angeles; National Institute of Nursing Research (NINR); The Miriam Hospital; Project Weber/RENEW; Open Door Health
• Investigators: Principal Investigator: Katie Biello, PhD, Brown University School of Public Health

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PrEP; Prevention; Male Sex Workers (MSW)
• Other Study ID Numbers: 2001002627; R01NR020227 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is anticipated that this data will be presented annually on data collected after the second year when sufficient baseline data is collected. It is anticipated that most of the papers and data-based projects/presentations will happen in year 3, when all of the baseline data is collected, and the 3 month outcome has occurred for all participants. Sharing of the findings will involve a primary paper describing the study outcome and a paper that describes the intervention, as well as submitting to lead workshops on the intervention approach at relevant national meetings and conferences. Raw data for additional analysis will be available to outside individuals through contacting the MPIs. Information regarding the availability of data for analysis will be listed on the MPIs' web pages. Contact information for the MPIs will be listed in all manuscripts and publications as another means to access data.
• IPD Sharing Time Frame: Raw data for additional analysis will be available to outside individuals through contacting the MPIs at two different times. The first will be after all of the baseline data is collected. The second will be after the publication and release of the primary outcome paper(s). The MPIs will store the data indefinitely and allow access for pooled data analysis projects, or projects for outside individuals.
• IPD Sharing Access Criteria: Raw data for additional analysis will be available to outside individuals through contacting the MPIs. We will institute a concept plan process where internal study staff first have the availability to write papers or give presentations on particular topics. After this, if outside individuals wish to analyze data, we will welcome this collaboration.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No