Pre-exposure Prophylaxis (PrEP) for Health

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University

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

200 Participants
are divided into 2 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