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IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention

Study acronym: EBAI
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Nov 2026 to Feb 2027 Secondary endpoints: details revised at 10 of 10 entriesv5 Show 1 more changeShow less
    • Secondary endpoints: details revised at 10 of 10 entries
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 930 to confirmed 3234 · Primary and study completion dates: Apr 2027 to Nov 2026 · Site details revisedv4 Show 3 more changesShow less
    • Enrollment target: estimated 930 to confirmed 3234
    • Primary and study completion dates: Apr 2027 to Nov 2026
    • Site details revised
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2024 to Apr 25, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2024 to Apr 25, 2024
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI.
Trial Details
NCT Number NCT06358885
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Hanoi Medical University, Johns Hopkins University, University of Washington, Washington University School of Medicine
Conditions HIV-1-infection, Unhealthy Alcohol Use
Enrollment 3,234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov