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Pre-exposure Prophylaxis (PrEP) for Health

Study acronym: PrEP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Primary completion date changed from estimate of May 15, 2026 to Jun 16, 2026
    • Study completion pushed from May 15, 2026 to Nov 2026
    • Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: Jul 1, 2025 to May 15, 2026
    • Site contacts updated at 1 of 2 sites
    v14
  3. Primary and study completion dates: Jun 1, 2025 to Jul 1, 2025v13
  4. Re-verified, no change to tracked fieldsv12
  5. Primary and study completion dates: Jul 2024 to Jun 1, 2025v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site details revised at 1 of 2 sitesv10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 2021 to Sep 2, 2021
    • Site details revised at 2 of 2 sites
    v9
  3. Start date: May 2021 to Jul 2021v8
  4. Lead sponsor: Boston University to Brown Universityv7 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 0 to 2
    • Secondary endpoint revised
    • Study description expanded, about 369 words
    • Collaborators: 1 to 6
    • Eligibility criteria shortened, about 2 words
  5. Start date: Mar 2021 to May 2021v6
  6. Start date: Feb 2021 to Mar 2021v5
  7. Start date: Jan 2021 to Feb 2021v4
  8. Start date: Oct 2020 to Jan 2021v3
  9. Start date: Aug 2020 to Oct 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04430257
Lead Sponsor Brown University
Collaborators: National Institute on Drug Abuse (NIDA), The Fenway Institute, AIDS Action Committee of Massachusetts, Greater Lawrence Family Health Center, University of California, San Diego, Beth Israel Deaconess Medical Center
Conditions
(from sponsor)		 Substance Dependence, HIV (Human Immunodeficiency Virus)
Related terms Acquired Immunodeficiency Syndrome, Substance-Related Disorders
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov