Pre-exposure Prophylaxis (PrEP) for Health

Recruiting now · Not applicable

Conditions studied: Substance Dependence, HIV (Human Immunodeficiency Virus)

In brief

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.

Key facts

Study ID

NCT04430257

Run by

Brown University

People needed

200

Starts

2021-09-02

Expected to finish

2026-05-15

Last updated by the study team

2025-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AIDS Action — Cambridge, Massachusetts, United States (enrolling)
• Greater Lawrence Family Health Center — Lawrence, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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