Pre-exposure Prophylaxis (PrEP) for Health
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:
🦠 Substance Dependence 🦠 HIV (Human Immunodeficiency Virus)
🗓️ Study Start (Actual) 2 September 2021
🗓️ Primary Completion (Estimated) 1 July 2025
✅ Study Completion (Estimated) 1 July 2025
👥 Enrollment (Estimated) 200
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Cambridge, Massachusetts, United States
📍 Lawrence, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 June 2020
  • First Submitted that Met QC Criteria 10 June 2020
  • First Posted 12 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 April 2024
  • Last Update Posted 2 April 2024
  • Last Verified April 2024