IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

NCT06094634 | Active Not Recruiting DMC

• 2 other identifiers: 23-0256R01AA030479
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

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-initiators.

Conditions

Unhealthy Alcohol Use

Keywords

Preexposure Prophylaxis (PrEP); Alcohol Intervention; Motivational Interviewing; Cognitive Behavioral Therapy; Motivational Enhancement Therapy; Cost Analysis; Economic Evaluation

Outcome Measures

Primary Outcomes (7)

• PrEP Persistence

  PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.

  12 months

• Heavy Drinking Days (Binge drinking)

  The number of days with ≥6 standard drinks of alcohol per occasion among the previous 30 days as assessed on the Timeline Followback.

  12 months

• Incremental Cost-Effectiveness Ratio (ICER)

  The incremental cost-effectiveness ratio (ICER) is expressed as the incremental cost of the Brief Alcohol Intervention (BAI) per quality adjusted life-year (QALY) gained. ICER is defined as \[Ci - Ca\]/\[Ei - Ea\] with Ci and Ca being the respective costs of the BAI \[i\] and assessment only \[a\], and Ei and Ea the corresponding effectiveness.

  12 months

• Acceptability of the brief alcohol intervention, as measured with mHIST

  Acceptability is an implementation-focused outcome and will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for consumers, which consists of 15 items containing responses on a 4-point Likert scale. The mhIST score is calculated as the mean score of all responses ranging from 0-3. Higher mhIST scores indicate higher acceptability.

  3 months

• Feasibility - proportion completed 4 sessions (intervention arm)

  Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The first metric will be the proportion of participants who completed all 4 sessions among those who were assigned to the intervention arm, measured from the date of randomization.

  17 weeks

• Feasibility - proportion completed 2 sessions (intervention arm)

  Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The second metric will be the proportion of participants who completed at least 2 sessions among those who were assigned to the intervention arm, measured from the date of randomization.

  17 weeks

• Feasibility - proportion completed 4 sessions (among initiators)

  Feasibility is an implementation-focused outcome and will be measured as the BAI completion rate among participants. Three metrics will be considered. The third metric will be the proportion of participants who completed at least 4 sessions among those who initiated at least one session, measured from the date of the first in-person session.

  10 weeks

Secondary Outcomes (5)

• PrEP Adherence

  Up to 12 months

• Risk-aligned PrEP use

  Up to 12 months

• Number of Drinking Days

  Up to 12 months

• Number of Drinks Per Drinking Day

  Up to 12 months

• Penetration

  Up to 7 weeks

Study Arms (2)

Assessment-only control

NO INTERVENTION

Participants receive study assessment visits and standard of care from providers at the PrEP clinic.

The Brief Alcohol Intervention (BAI)

EXPERIMENTAL

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.

Behavioral: The Brief Alcohol Intervention (BAI): Behavioral

Interventions

The Brief Alcohol Intervention (BAI): Behavioral 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.

The Brief Alcohol Intervention (BAI)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age or older
• Intention to receive PrEP care in Hanoi for 12 months
• Willingness to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• Hanoi Medical University: collaborator
• Johns Hopkins University: collaborator
• University of Washington: collaborator
• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 39164770 DERIVED

MeSH Terms

Interventions

Ethanol; Methods

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Vivian F Go, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• William C Miller, MD, PhD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

• Le Minh Giang, MD, PhD

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: April 3, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

VN (1)