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
2 other identifiers
interventional
500
1 country
5
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2022
CompletedFirst Submitted
Initial submission to the registry
February 8, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedMay 9, 2025
May 1, 2025
3.6 years
February 8, 2023
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
PrEP persistence
12-month post Stage 2 randomization
Study Arms (4)
Stage 1 Standard of Care (SOC) Control Condition
NO INTERVENTIONSOC participants will receive an informational pamphlet about the PrEP as a form of HIV prevention and referrals to local PrEP Prescribers.
Stage 1 Strength Based Case Management (SBCM) Condition
EXPERIMENTALIntervention 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 SOC Control Condition
NO INTERVENTIONResearch 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.
Stage 2 PrEPare for Work Intervention Condition
EXPERIMENTALIntervention 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- The Miriam Hospitalcollaborator
- University of California, Los Angelescollaborator
- Project Weber/RENEWcollaborator
- Open Door Healthcollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (5)
UCLA Fielding School of Public Health
Los Angeles, California, 90095, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Open Door Health
Providence, Rhode Island, 02907, United States
Project Weber/RENEW
Providence, Rhode Island, 02907, United States
Brown University School of Public Health
Providence, Rhode Island, 02912, United States
Related Publications (1)
Biello KB, Chan PA, Ndoye CD, Nelson L, Nelson E, Silva V, Kwak E, Napoleon S, Cormack Orellana C, Richards OG, Davis E, Mimiaga MJ. Study protocol of a randomized controlled trial to assess the efficacy of the "PrEPare for Work" intervention to enhance PrEP uptake and optimize adherence for HIV prevention among male sex workers in the U.S. BMC Public Health. 2024 Feb 9;24(1):424. doi: 10.1186/s12889-024-17710-y.
PMID: 38336731DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Katie Biello, PhD
Brown University School of Public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2023
First Posted
February 21, 2023
Study Start
November 3, 2022
Primary Completion
June 1, 2026
Study Completion
June 1, 2026
Last Updated
May 9, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- 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.
- 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.
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.