IGHID 12219 - A Brief Alcohol Intervention for PrEP Users
NCT ID: NCT06094634
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
562 participants
INTERVENTIONAL
2024-04-03
2027-01-31
Brief Summary
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Detailed Description
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The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and includes 2 in-person sessions and 2 telephone sessions.
Eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). Additional assessments among a subset of participants in the BAI arm will assess acceptability of the intervention (n=48).
Study activities will span 5 years. Individual PrEP initiators and re-initiators will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Assessment-only control
Participants receive study assessment visits and standard of care from providers at the PrEP clinic.
No interventions assigned to this group
The Brief Alcohol Intervention (BAI)
Participants receive the Brief Alcohol Intervention (2 in-person sessions and 2 phone sessions), study assessment visits, and standard of care from providers at the PrEP clinic.
The Brief Alcohol Intervention (BAI): Behavioral
The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and comprises 2 in-person face-to-face sessions and 2 booster telephone sessions by a trained counselor.
Interventions
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The Brief Alcohol Intervention (BAI): Behavioral
The BAI draws from Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT) and comprises 2 in-person face-to-face sessions and 2 booster telephone sessions by a trained counselor.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
16 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
National Institutes of Health (NIH)
NIH
Hanoi Medical University
OTHER
Johns Hopkins University
OTHER
University of Washington
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Vivian F Go, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
William C Miller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Le Minh Giang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanoi Medical University
Locations
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Hanoi Medical University
Hanoi, , Vietnam
Countries
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References
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Bui HTM, Giang LM, Chen JS, Sripaipan T, Nong HTT, Nguyen NTK, Bartels SM, Rossi SL, Hutton H, Chander G, Sohn H, Ferguson O, Tran HV, Nguyen MX, Nguyen KD, Rutstein SE, Levintow S, Hoffman IF, Powell BJ, Pence BW, Go VF, Miller WC. A Brief Alcohol Intervention (BAI) to reduce alcohol use and improve PrEP outcomes among men who have sex with men in Vietnam: study protocol for a randomized controlled trial. Trials. 2024 Aug 21;25(1):552. doi: 10.1186/s13063-024-08382-5.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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23-0256
Identifier Type: -
Identifier Source: org_study_id