NCT04430257 Pre-exposure Prophylaxis (PrEP) for Health
| NCT ID | NCT04430257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brown University |
| Condition | Substance Dependence |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-09-02 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2021-09-02 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Katie Biello, PhD, MPH
PRINCIPAL INVESTIGATOR
Brown University
Frequently Asked Questions
Who can join the NCT04430257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Substance Dependence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04430257 currently recruiting?
Yes, NCT04430257 is actively recruiting participants. Contact the research team at katie_biello@brown.edu for enrollment information.
Where is the NCT04430257 trial being conducted?
This trial is being conducted at Cambridge, United States, Lawrence, United States.
Who is sponsoring the NCT04430257 clinical trial?
NCT04430257 is sponsored by Brown University. The principal investigator is Katie Biello, PhD, MPH at Brown University. The trial plans to enroll 200 participants.