Status:
ACTIVE_NOT_RECRUITING
IGHID 12219 - A Brief Alcohol Intervention for PrEP Users
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health (NIH)
Conditions:
Unhealthy Alcohol Use
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (BAI) vs. standard of care (SOC) to improve pre-exposure prophylaxis (PrEP) use among PrEP initiators and re-...
Detailed Description
This is a two-arm effectiveness randomized controlled trial (RCT) to compare the brief alcohol intervention (BAI) to the standard of care (SOC) among PrEP initiators and re-initiators with unhealthy a...
Eligibility Criteria
Inclusion
- Newly initiating PrEP or re-initiating PrEP after at least 3 months from a missed PrEP appointment, based on local PrEP guidelines
- AUDIT-C score ≥ 4 or CRAFFT score ≥ 2 (for those ≤21 years old)
- 16 years of age or older
- Intention to receive PrEP care in Hanoi for 12 months
- Willingness to provide informed consent
Exclusion
- Psychological disturbance, cognitive impairment, or threatening behavior
- Unwilling to provide locator information
- Current participation in alcohol programs or studies
- Current participation in other research studies (including HIV and PrEP studies)
- Ever enrolled in an HIV vaccine study
- Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) ≥ 10, indicating risk for alcohol withdrawal
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2027
Estimated Enrollment :
562 Patients enrolled
Trial Details
Trial ID
NCT06094634
Start Date
April 3 2024
End Date
January 1 2027
Last Update
December 17 2025
Active Locations (1)
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1
Hanoi Medical University
Hanoi, Vietnam