Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04430257

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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