Unhealthy Alcohol UseBPrEPNCT06094634
IGHID 12219 - A Brief Alcohol Intervention for PrEP Users
A study testing The Brief Alcohol Intervention (BAI): Behavioral in people with Unhealthy Alcohol Use, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Unhealthy Alcohol Use
- What is being tested?
- The Brief Alcohol Intervention (BAI): Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 562 participants
- Where
- 1 siteVietnam
- Study dates
- 3 Apr 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Unhealthy Alcohol Use
- Being tested
- The Brief Alcohol Intervention (BAI): Behavioral
- Keywords
- Preexposure Prophylaxis (PrEP), Alcohol Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Cost Analysis, Economic Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Brief Alcohol Intervention (BAI): BehavioralBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The Brief Alcohol Intervention (BAI): Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Persistence
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Secondary outcomes (5)
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.
Measured: Up to 12 months
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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Penetration
Completion of at least one session among those assigned to the intervention arm, measured from the date of randomization.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start3 Apr 2024
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unhealthy Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 562 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Hanoi Medical University, Johns Hopkins University, University of Washington
- Responsible party
- Sponsor
- Investigators
- Vivian F Go, PhD, Principal investigator, University of North CarolinaWilliam C Miller, MD, PhD, Principal investigator, University of North CarolinaLe Minh Giang, MD, PhD, Principal investigator, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094634
- Sponsor's protocol ID
- 23-0256
- Other IDs
- R01AA030479
- Acronym
- BPrEP
- Status last verified
- Dec 2025
- First submitted
- 16 Oct 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 39164770
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 12219 - A Brief Alcohol Intervention to Reduce Alcohol Use and Improve PrEP Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06094634
- Acronym / sponsor ID
- BPrEP / 23-0256
- Conditions
- Unhealthy Alcohol Use
- Keywords
- Preexposure Prophylaxis (PrEP), Alcohol Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Motivational Enhancement Therapy, Cost Analysis, Economic Evaluation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 562 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH), Hanoi Medical University, Johns Hopkins University, University of Washington
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: The Brief Alcohol Intervention (BAI): BehavioralParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Brief Alcohol Intervention (BAI): BehavioralThe 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. | Behavioural | The Brief Alcohol Intervention (BAI) |
Primary outcome
PrEP Persistence
Time frame: 12 months
PrEP persistence is a measure of ongoing PrEP usage, defined as consistent presentation for care and refills.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
PrEP Adherence
Time frame: Up to 12 months
Risk-aligned PrEP use
Time frame: Up to 12 months
Number of Drinking Days
Time frame: Up to 12 months
Number of Drinks Per Drinking Day
Time frame: Up to 12 months
Penetration
Time frame: Up to 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 39164770Bui 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian F Go, PhD principal investigator
University of North Carolina
William C Miller, MD, PhD principal investigator
University of North Carolina
Le Minh Giang, MD, PhD principal investigator
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Brief Alcohol Intervention (BAI): Behavioral in people with Unhealthy Alcohol Use, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Persistence (time frame: 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06094634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.