Pre-exposure Prophylaxis (PrEP) for Health

Recruiting · NCT04430257 · Interventional (participants receive a specific treatment) · Lead sponsor: Brown University

View the official record on ClinicalTrials.gov →

Interventions studied

HIV and PrEP educationMotivational interviewingPatient navigationPrEP informationProblem-solving and planningReferrals

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

Where it is running

2 locations listed across 1 US state.

AIDS Action - Cambridge, Massachusetts, United States
Greater Lawrence Family Health Center - Lawrence, Massachusetts, United States

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →