Clinical trial NCT03086057: Optimizing PrEP Uptake & Adherence Among Male Sex Workers (MSW) Using a 2-stage Randomization Design
Official title: Optimizing Pre-exposure Prophylaxis (PrEP) Uptake & Adherence Among MSW Using a 2-stage Randomization Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention
Keywords: PrEP
Prevention
Male Sex Workers (MSW)
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
First posted: 2017-03-22
Enrollment: 111
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Verified Attendance at Initial Appointment at PrEP Clinic
timeFrame: 2-month post Stage 1 randomization
measure: Number of Participants Who Initiated PrEP
timeFrame: 2-month post Stage 1 randomization
measure: Number of Participants Reporting Optimal PrEP Adherence
timeFrame: 6-months post Stage 2 randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University, School of Public Health, Center for Health Equity Research
name: Matthew J Mimiaga, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: