IGHID 12219 - A Brief Alcohol Intervention for PrEP Users (BPrEP)

IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unhealthy Alcohol Use
• Intervention / Treatment: Behavioral: The Brief Alcohol Intervention (BAI): Behavioral

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 alcohol use who are initiating or reinitiating oral, event-driven, or injectable PrEP.

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.

• Study Type: Interventional
• Enrollment (Actual): 562
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Assessment-only control; Participants receive study assessment visits and standard of care from providers at the PrEP clinic.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP Persistence	PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.	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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk-aligned PrEP use	Risk-aligned PrEP use is a measure of whether PrEP use is consistent with concurrent risk behavior. It is defined as persistent oral/injectable PrEP, event-driven PrEP (2+1+1), or clinician-supervised PrEP discontinuation. More specifically, risk-aligned PrEP is defined as: Persistent oral, event-driven or injectable PrEP,; Clinician-approved PrEP discontinuation.	Up to 12 months
Number of Drinking Days	Number of drinking days is defined as the number of days with any alcohol use, among the previous 30 days as assessed on the Timeline Followback. The timeline followback will be administered at enrollment, 3 months and 12 months.	Up to 12 months
Number of Drinks Per Drinking Day	Drinks per drinking day is defined as the number of standard drinks of alcohol consumed on a drinking day, among the past 30 days as assessed on the Timeline Followback. The timeline followback will be administered at enrollment, 3 months and 12 months.	Up to 12 months
PrEP Adherence	PrEP adherence is a measure of pill-taking behavior and will be assessed by self-report and pharmacy records. Adherence will be assessed per person based on the type of PrEP prescribed but will be compared as a single measure. Oral and event-driven PrEP adherence will be assessed as self-reported number of doses taken. Oral PrEP adherence is defined with two thresholds: ≥ 4 days/week, a threshold consistent with standard prevention definitions, and 7 days/week, indicating perfect adherence. Event-driven PrEP adherence will be defined as completion of the 2+1+1 regimen for every reported intercourse event.	Up to 12 months
Penetration	Completion of at least one session among those assigned to the intervention arm, measured from the date of randomization.	Up to 7 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Johns Hopkins University; National Institutes of Health (NIH); University of Washington; Hanoi Medical University
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Cognitive Behavioral Therapy; Motivational Enhancement Therapy; Cost Analysis; Economic Evaluation; Alcohol Intervention; Preexposure Prophylaxis (PrEP)
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Organic Chemicals; Investigative Techniques; Alcohols; Ethanol; Methods
• Other Study ID Numbers: 23-0256; R01AA030479 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No