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Implementing PrEP for Women Who Inject Drugs

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2026 (before its estimated September 24, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion moved earlier from Mar 24, 2027 to Sep 24, 2026 Study description revised · Eligibility criteria expanded, about 5 words Show 2 more changesShow less
    • Study description revised
    • Eligibility criteria expanded, about 5 words
  2. Trial status changed: Enrolling by Invitation → Active, Not Recruiting Primary and study completion dates: Mar 31, 2027 to Mar 24, 2027v6 Show 1 more changeShow less
    • Primary and study completion dates: Mar 31, 2027 to Mar 24, 2027
  3. Primary and study completion dates: Dec 31, 2025 to Mar 31, 2027 Trial status: Recruiting to Enrolling by Invitation · Site details revisedv5 Show 2 more changesShow less
    • Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
  4. Primary and study completion dates: May 31, 2025 to Dec 31, 2025 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
  5. Enrollment target: 86 to 130 Primary completion date: May 31, 2024 to May 31, 2025v3 Show 1 more changeShow less
    • Primary completion date: May 31, 2024 to May 31, 2025
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Women who inject drugs are among the most vulnerable to acquiring HIV, but very few women who inject drugs are prescribed pre-exposure prophylaxis (PrEP) for HIV prevention largely due to barriers within our healthcare system. This research will consider the perspectives of women who inject drugs, healthcare providers, and clinic leadership to improve the way primary care and reproductive health clinics deliver PrEP to women who inject drugs, thereby reducing new HIV infections in this population.
Trial Details
NCT Number NCT05360849
Lead Sponsor University of Pennsylvania
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions HIV, Intravenous Substance Abuse, Women's Health, Organization and Administration, Primary Prevention, Implementation Science
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov