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Pre-exposure Prophylaxis (PrEP) for Health

Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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
* Able to understand and speak English or Spanish

Exclusion Criteria:

* 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

About the study

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.

What is being tested

• HIV and PrEP education (other)
• Motivational interviewing (behavioral)
• Problem-solving and planning (behavioral)
• Patient navigation (behavioral)
• PrEP information (other)
• Referrals (other)

Sponsor: Brown University · Participants: 200 · Started: Sep 2, 2021

Contact the study team

• Katie Biello, PhD, MPH · Phone: 401-863-6551

Official record on ClinicalTrials.gov — NCT04430257

Locations in the U.S.

Conditions

• Drug Use and Addiction
• HIV

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.