Efficacy of a Community-based PrEP Uptake Intervention for People Who Inject Drugs (PWID) in the US Northeast

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
AIDS Action
RECRUITING
Cambridge
Greater Lawrence Family Health Center
RECRUITING
Lawrence
Contact Information
Primary
Katie Biello, PhD, MPH
katie_biello@brown.edu
401-863-6551
Backup
Angela Bazzi, PhD
abazzi@health.ucsd.edu
Time Frame
Start Date: 2021-09-02
Estimated Completion Date: 2026-05-15
Participants
Target number of participants: 200
Treatments
Experimental: PrEP for health
Participants in the PrEP (pre-exposure prophylaxis) for health arm will receive theory informed HIV and PrEP education, motivational interviewing, problem-solving and planning, and ongoing patient navigation.
Active_comparator: Standard of care
Participants in the standard of care arm will receive PrEP information and referrals.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), AIDS Action Committee of Massachusetts, University of California, San Diego, Beth Israel Deaconess Medical Center, Greater Lawrence Family Health Center, The Fenway Institute
Leads: Brown University

This content was sourced from clinicaltrials.gov