Actively Recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Led by Brown University · Updated on 2025-05-04
200
Participants Needed
2
Research Sites
245 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-exposure Prophylaxis (PrEP) for Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HIV-uninfected verified by rapid or 4th generation test
- Injected any drugs in the past month
- Engaged in one or more HIV risk behaviors in the past month such as 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 will not qualify if you...
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at enrollment
- Living in Massachusetts for less than 3 months
- Planning to move out of Massachusetts within a year
AI-Screening
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Trial Site Locations
Total: 2 locations
1
AIDS Action
Cambridge, Massachusetts, United States, 02139
Actively Recruiting
2
Greater Lawrence Family Health Center
Lawrence, Massachusetts, United States, 01841
Actively Recruiting
Research Team
K
Katie Biello, PhD, MPH
CONTACT
A
Angela Bazzi, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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