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

Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086057
• Other study ID #: 1R34MH110369-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prevention

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants Who Initiated PrEP	Initial prescription from provider filled and shown to study staff	2-month post Stage 1 randomization
Primary	Number of Participants Reporting Optimal PrEP Adherence	Self-reporting missing 0 PrEP pills in the past week	6-months post Stage 2 randomization