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NCT Number: NCT06094634

IGHID 12219 - A Brief Alcohol Intervention for PrEP Users

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Unhealthy Alcohol Use

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanoi Medical University

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PrEP Persistence

    Time frame: 12 months

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

  2. Heavy Drinking Days (Binge drinking)

    Time frame: 12 months

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

  3. Incremental Cost-Effectiveness Ratio (ICER)

    Time frame: 12 months

    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.

  4. Acceptability of the brief alcohol intervention, as measured with mHIST

    Time frame: 3 months

    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.

  5. Feasibility - proportion completed 4 sessions (intervention arm)

    Time frame: 17 weeks

    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.

  6. Feasibility - proportion completed 2 sessions (intervention arm)

    Time frame: 17 weeks

    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.

  7. Feasibility - proportion completed 4 sessions (among initiators)

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. PrEP Adherence

    Time frame: Up to 12 months

    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.

  2. Risk-aligned PrEP use

    Time frame: Up to 12 months

    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.

  3. Number of Drinking Days

    Time frame: Up to 12 months

    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.

  4. Number of Drinks Per Drinking Day

    Time frame: Up to 12 months

    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.

  5. Penetration

    Time frame: Up to 7 weeks

    Completion of at least one session among those assigned to the intervention arm, measured from the date of randomization.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Hanoi Medical University
  • Johns Hopkins University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institutes of Health (NIH)
  • University of Washington

Registry information

Official study title

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

Acronym: BPrEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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