Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design

Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design

"PrEPare for Work" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Male Sex Workers (MSW).

Study Overview

• Status: Completed
• Conditions: Prevention
• Intervention / Treatment: Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1); Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2)

Detailed Description

The "PrEPare for Work" package includes two behavioral intervention components:

1. Strengths-based case management for PrEP initiation, and
2. Counseling and problem-solving PrEP adherence intervention that addresses individualized barriers to optimal use.

Stage 1: MSW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.

Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEPare for Work" adherence intervention or standard of care comparison condition.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02912
      • Brown University School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 18 years of age or older
• Biological male at birth and current male gender identity
• Exchanged sex for money or drugs with another man in the past 3 months
• Report behavioral risk for HIV infection, consistent with Centers for Disease Control and Prevention guidelines for prescribing PrEP: condomless anal intercourse with at least one HIV-infected or unknown serostatus partner in the past three months
• HIV uninfected by antibody test* Stage 2
• Able to understand and speak English (for consent and counseling)
• Mental competency to provide voluntary informed consent
• Lives in the New England area
• Willing to initiate PrEP

Exclusion Criteria:

• Unable to provide informed consent, including as a result of severe mental illness requiring immediate treatment or mental illness limiting the ability to participate
• HIV Positive at baseline
• Infected with Hepatitis B or diagnosed with renal insufficiency (glomerular filtration rate < 50) *Stage 2
• History of or current medical conditions that would preclude taking Truvada for PrEP *Stage 2
• Currently taking Truvada for PrEP

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Strength Based Case Management; Stage 1: Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.	Behavioral: PrEPare for Work: Strength Based Case Management (Stage 1); Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
EXPERIMENTAL: PrEP adherence training and counseling; Stage 2: Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.	Behavioral: PrEPare for Work: Adherence Training and Counseling (Stage 2); Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
NO_INTERVENTION: Standard of Care:Stage 1; Stage 1: Referral to The Miriam Hospital PrEP Clinic.
NO_INTERVENTION: Standard of Care: Stage 2; Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic	Number of participants with attendance at initial appointment at PrEP Clinic verified using medical records	2-month post Stage 1 randomization
Number of Participants Who Initiated PrEP	Initial prescription from provider filled and shown to study staff	2-month post Stage 1 randomization
Number of Participants Reporting Optimal PrEP Adherence	Self-reporting missing 0 PrEP pills in the past week	6-months post Stage 2 randomization

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: The Miriam Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): December 15, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 21, 2017
• First Posted (ACTUAL): March 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: PrEP; Prevention; Male Sex Workers (MSW)
• Other Study ID Numbers: 1R34MH110369-01 (NIH)

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.

Drug and device information, study documents

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