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Study identifier: NCT04430257 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Pre-exposure Prophylaxis (PrEP) for Health

Condition: Substance Dependence · HIV (Human Immunodeficiency Virus)  ·  Sponsor: Brown University

PhaseNA
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Katie Biello, PhD, MPH  ·  401-863-6551  ·  katie_biello@brown.edu

Angela Bazzi, PhD  ·  abazzi@health.ucsd.edu

Always discuss trial participation with your own doctor first.

Locations (2)

AIDS ActionCambridge, Massachusetts, United StatesRecruiting
Greater Lawrence Family Health CenterLawrence, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04430257