NCT04430257Active, not recruiting
Pre-exposure Prophylaxis (PrEP) for Health
Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 10 Jun 2020
- Start date
- 2 Sept 2021
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- Brown University
- Diseases
- HIV
- NCT number
- NCT04430257
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 2 Sept 2021 to the primary completion date, 16 Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at the time of enrollment
Other
- Living in Massachusetts (MA) for \<3 months
- Planning to move out of MA within a year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIDS Action Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
| Greater Lawrence Family Health Center Coordinator of this site? Confirm its status | Lawrence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.