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

NCT03086057 | Completed Results DMC

• 1 other identifier: 1R34MH110369-01
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

"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).

Conditions

Prevention

Keywords

PrEP; Prevention; Male Sex Workers (MSW)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Strength Based Case Management

EXPERIMENTAL

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)

PrEP adherence training and counseling

EXPERIMENTAL

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)

Standard of Care:Stage 1

NO INTERVENTION

Stage 1: Referral to The Miriam Hospital PrEP Clinic.

Standard of Care: Stage 2

NO INTERVENTION

Stage 2: Doctor visit every three months to assess for side effects and receive a HIV test.

Interventions

PrEPare for Work: Strength Based Case Management (Stage 1) BEHAVIORAL

Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.

Strength Based Case Management

PrEPare for Work: Adherence Training and Counseling (Stage 2) BEHAVIORAL

Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.

PrEP adherence training and counseling

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological male at birth and current male gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• The Miriam Hospital: collaborator

Study Sites (2)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Due to COVID, we are delayed in receiving the results of our biomarkers (specifically, hair analysis for PrEP adherence).

Results Point of Contact

• Title: Dr. Katie Biello
• Organization: Brown University

katie_biello@brown.edu

401-863-3082

Study Officials

• Matthew J Mimiaga, ScD, MPH

  Brown University, School of Public Health, Center for Health Equity Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: ScD, MPH

Model Details: In Stage 1, individuals will be randomized (1:1) to receive the experimental PrEP navigation or standard of care. Among those who uptake PrEP in Stage 1, we will randomize those participants in Stage 2 (1:1) to receive the experimental adherence counseling or standard of care.

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 22, 2017
• Study Start: May 1, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: March 15, 2021
• Results First Posted: March 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)