About this trial
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.
Eligibility criteria
Qualifiers
HIV-uninfected (verified by rapid/4th generation test)
Reporting past-month injection of any drugs
One or more HIV risk behaviors (past-month receptive syringe sharing, transactional sex, or condomless sex with an HIV-infected or unknown-status partner)
Not currently on and never taken PrEP
Disqualifiers
Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
Living in Massachusetts (MA) for <3 months
Planning to move out of MA within a year
Trial design
Treatments tested in this trial
- HIV and PrEP education
- Motivational interviewing
- Problem-solving and planning
- Patient navigation
- PrEP information
- Referrals
Treatment groups
Sponsors and collaborators
Brown University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
The Fenway Institute
Collaborator
AIDS Action Committee of Massachusetts
Collaborator
Greater Lawrence Family Health Center
Collaborator
University of California, San Diego
Collaborator
Beth Israel Deaconess Medical Center
Collaborator