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Pre-exposure Prophylaxis (PrEP) for Health
Sponsor: Brown University
Summary
This randomized controlled trial will test the efficacy of "PrEP for Health," a behavioral intervention to improve the use of antiretroviral pre-exposure prophylaxis (PrEP) among at-risk people who inject drugs (PWID) in two syringe service program (SSP) settings in Lawrence and Boston/Cambridge, Massachusetts. The investigators will equally randomize 200 PWID to receive either (a) the "PrEP for Health" intervention condition involving theory-informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation (n=100), or (b) the standard of care condition involving PrEP information and referrals (n=100). Successful PrEP uptake (via medical/pharmacy records), post-treatment PrEP adherence (assessed at 3 months via drug levels in hair), and longer-term PrEP adherence (assessed at 6 and 12 months via drug levels in hair) will be evaluated. The degree to which intervention efficacy occurs through specific conceptual mediators and differs according to hypothesized moderators will also be evaluated.
Official title: Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2021-09-02
Completion Date
2026-05-15
Last Updated
2025-05-04
Healthy Volunteers
No
Interventions
HIV and PrEP education
Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
Motivational interviewing
Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
Problem-solving and planning
Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
Patient navigation
Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
PrEP information
A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
Referrals
Study staff will provide basic information about PrEP and referrals to PrEP clinicians.
Locations (2)
AIDS Action
Cambridge, Massachusetts, United States
Greater Lawrence Family Health Center
Lawrence, Massachusetts, United States