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ED2PrEP - Patient Focused, Low-burden Strategies for PrEP Uptake Among Emergency Departments

Study acronym: ED2PrEP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Recruiting to Active, Not Recruitingv9 Show 7 more changesShow less
    • Enrollment target: 1416 to 1560
    • Primary completion date changed from estimate of Jan 31, 2026 to Feb 13, 2026
    • Study completion date: Jan 31, 2027 to Nov 13, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 26 words
    • Study sites revised (2)
  3. Primary completion date: Feb 2026 to Jan 31, 2026
    • Study completion date: May 2027 to Jan 31, 2027
    v8
  4. Study completion date: Feb 2027 to May 2027
    • Start date changed from estimate of Sep 2024 to Oct 1, 2024
    v7
  5. Primary completion date: Jan 2026 to Feb 2026
    • Study completion date: Jan 2027 to Feb 2027
    • Start date: Aug 2024 to Sep 2024
    • Site details revised at 1 of 2 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Jul 2024 to Aug 2024v5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 8 more changesShow less
    • Start date: Mar 2024 to Jul 2024
    • Enrollment target: 1000 to 1416
    • Primary completion date: Sep 2025 to Jan 2026
    • Study completion date: Dec 2026 to Jan 2027
    • Interventions: PVO (Behavioral), TS (Behavioral) to PVO (Behavioral), TSH (Behavioral)
    • Eligibility criteria expanded, about 47 words
    • Study description expanded, about 170 words
    • Site details revised at 2 of 2 sites
  3. Start date: Nov 2023 to Mar 2024
    • Primary completion date: May 2025 to Sep 2025
    • Study completion date: Aug 2026 to Dec 2026
    • Site contacts updated at 1 of 2 sites
    v3
  4. Lead sponsor: Viraj V. Patel to Albert Einstein College of Medicinev2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Apr 2025 to May 2025
    • Study completion date: Jul 2026 to Aug 2026
    • Start date: Oct 2023 to Nov 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use in communities hardest hit by the HIV epidemic persist, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. In these same communities, many patients at risk for HIV seek care for sexually transmitted infections (STIs) in Emergency Departments (EDs), but the structure of traditional ED care is poorly suited to address HIV prevention or provide PrEP. To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.
Trial Details
NCT Number NCT05588193
Lead Sponsor Albert Einstein College of Medicine
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 HIV
Enrollment 1,560 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov