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A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

Study acronym: EBONI
StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Oct 1, 2026 Primary endpoint revised · Enrollment target: 370 to 295 · Eligibility criteria expanded, about 10 words · 3 more Show 6 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 370 to 295
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: 49 to 161
    • Site details revised at 1 of 22 sites
    • Publications: details revised at 1 of 1 entry
  2. Enrollment target: 162 to 370v10
  3. Trial status: Active, Not Recruiting to Completed Enrollment target: 165 to 162 · Primary and study completion dates changed from estimate of Aug 29, 2025 to Sep 2, 2025v9 Show 2 more changesShow less
    • Enrollment target: 165 to 162
    • Primary and study completion dates changed from estimate of Aug 29, 2025 to Sep 2, 2025
  4. Enrollment target: 156 to 165 Study sites: 20 to 22v8 Show 1 more changeShow less
    • Study sites: 20 to 22
  5. Enrollment target: 66 to 156 Primary and study completion dates: Sep 30, 2025 to Aug 29, 2025v7 Show 1 more changeShow less
    • Primary and study completion dates: Sep 30, 2025 to Aug 29, 2025
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 250 to confirmed 66 · Study sites: 22 to 20v6 Show 2 more changesShow less
    • Enrollment target: estimated 250 to confirmed 66
    • Study sites: 22 to 20
  2. Study sites: 21 to 22 Primary and study completion dates: May 30, 2025 to Sep 30, 2025v5 Show 1 more changeShow less
    • Primary and study completion dates: May 30, 2025 to Sep 30, 2025
  3. Primary and study completion dates: Oct 24, 2024 to May 30, 2025 Study sites: 14 to 21v4 Show 1 more changeShow less
    • Study sites: 14 to 21
  4. Study sites: 8 to 14 Primary and study completion dates: Oct 25, 2024 to Oct 24, 2024 · Start date: Oct 31, 2022 to Oct 28, 2022v3 Show 2 more changesShow less
    • Primary and study completion dates: Oct 25, 2024 to Oct 24, 2024
    • Start date: Oct 31, 2022 to Oct 28, 2022
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Primary and study completion dates: Aug 19, 2024 to Oct 25, 2024 · Start date changed from estimate of Aug 23, 2022 to Oct 31, 2022v2 Show 3 more changesShow less
    • Study sites: 0 to 8
    • Primary and study completion dates: Aug 19, 2024 to Oct 25, 2024
    • Start date changed from estimate of Aug 23, 2022 to Oct 31, 2022
  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.
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
Trial Details
NCT Number NCT05514509
Lead Sponsor ViiV Healthcare
Conditions HIV Infections
Enrollment 295 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov