HIV-1-infectionEBAINCT06358885
IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
A study testing Facilitation (FAC) and Experiential Brief Alcohol Intervention (EBAI) in people with HIV-1-infection and Unhealthy Alcohol Use, run by University of North Carolina, Chapel Hill at 1 site in Vietnam.
Trial summary
This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Unhealthy Alcohol Use
- What is being tested?
- Facilitation (FAC) and Experiential Brief Alcohol Intervention (EBAI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,234 participants
- Where
- 1 siteVietnam
- Study dates
- 25 Apr 2024to Feb 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PWH cohort participants
- Person living with HIV at any stage of HIV infection
- Currently attending the study ART clinic at any ART stage (initiating or receiving ART)
- AUDIT-C score >=4 for men or >=3 for women
- >= 18 years of age
- Willing to provide informed consent, which includes consenting to interview and collection of dried blood spots
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- Clinic staff participants:
- Work at the ART clinic as a clinic director, physician, nurse, or counselor
- Willing to provide informed consent
Who cannot join
- PWH cohort participants:
- Psychological disturbance preventing participation
- Cognitive impairment
- Threatening behavior
- Unwilling to provide locator information Note: If a participant screens positive with the AUDIT-C and is identified to be at substantial risk for alcohol withdrawal based on the Mini International Neuropsychiatric Interview (MINI) and Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA) will be referred for treatment. They will not be eligible for enrollment until after alcohol withdrawal concerns are addressed.
- These participants may be rescreened, consented, and enrolled after treatment.
- Clinic staff participants:
- Psychological disturbance, cognitive impairment, or threatening behavior
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IGHID 12230 - Scaling up the Brief Alcohol Intervention to Prevent HIV Infection in Vietnam: a Cluster Randomized, Implementation Trial (EBAI)
This study is a hybrid type 3, cluster randomized implementation trial to examine effective strategies to scale up the Brief Alcohol Intervention (BAI) in ART clinics in Vietnam. One arm will receive only facilitation for BAI implementation. Facilitation is a flexible strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits. In the other arm, in addition to facilitation, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves as experiential learning (EBAI) to address their own alcohol-related attitudes and behaviors. Clinic staff responsible for delivering the BAI to patients will also be offered 3 consolidation activities to integrate their own experiences with their delivery of the BAI.
Read the detailed description
In this cluster-randomized controlled, hybrid type 3 implementation trial, investigators will assess two approaches to the brief alcohol intervention (BAI) scale-up. The BAI is an evidence-based intervention to address unhealthy alcohol use that comprises 2 in-person sessions and 2 booster telephone sessions. Face-to-face 45-minute sessions occur ~1 month apart; 10-minute telephone sessions occur 2 to 3 weeks after each face-to-face session. Investigators chose a hybrid type 3 design to evaluate implementation outcomes, while simultaneously ensuring that effectiveness outcomes, specifically viral suppression, are achieved. Investigators will compare facilitation (FAC) versus EBAI+FAC in 30 ART clinics in Vietnam. The FAC arm, the comparison arm, will use internal and external facilitators to help clinics and staff address common barriers to BAI implementation. Facilitation typically works through interactive problem solving and support. In the EBAI+FAC arm, clinic staff, defined as clinic directors, physicians, nurses, and counselors, will be offered the experiential BAI (EBAI), regardless of their own alcohol use, prior to BAI implementation, and clinic staff responsible for delivering the BAI to patients will also be offered 3 additional consolidation opportunities to integrate their own experiences with their delivery of the BAI to PWH. Randomization will be 1:1 with 15 clinics per arm. Clinics will be assessed pre-training for key contextual factors, related to clinic characteristics and clinic staff.
Upon trial initiation, persons with HIV (PWH) initiating or on ART will be screened for unhealthy alcohol use with the AUDIT-C (Time 0). Those PWH who screen positive for unhealthy alcohol use will be offered the BAI by trained clinic counselors. PWH who do not screen positive will continue to be screened with the AUDIT-C at routine ART clinic visits. PWH who screen positive but refuse to participate in the trial or are excluded due to alcohol withdrawal symptoms will continue to be screened with the AUDIT-C at every routine ART clinic visit per standard clinic procedures. PWH may decline AUDIT screening when it is offered. Implementation and effectiveness outcomes will be evaluated to 12 or 24 months (Aim 1). After the 12- month assessments, mechanisms underlying successful implementation in both arms will be explored using qualitative and quantitative methods (Aim 2). Investigators will explore the effect of implementing the BAI (both arms) and experiencing the BAI (EBAI+FAC arm) on staff members' alcohol use and attitudes toward alcohol and BAI (Aim 3).
- Conditions
- HIV-1-infection, Unhealthy Alcohol Use
- Being tested
- Facilitation (FAC), Experiential Brief Alcohol Intervention (EBAI)
- Keywords
- Alcohol intervention, Cluster randomized controlled implementation trial, Implementation Science, HIV/AIDS, Antiretroviral therapy, Cognitive behavioral therapy, Motivational Interviewing, Motivational Enhancement Therapy, Cost Analysis, Economic Evaluation, Vietnam
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitation (FAC)Other
The facilitation approach will use a flexible clinic level implementation strategy that helps clinics to address common barriers, such as counselor skills, competing priorities, and resource deficits.
Experiential Brief Alcohol Intervention (EBAI)Behavioural
Clinic staff will be offered the experiential BAI prior to implementation. The BAI comprises 2 in-person sessions and 2 booster phone sessions. Clinic staff responsible for delivering the BAI to PWH participants will be offered 3 additional consolidation sessions to integrate their experiences receiving the BAI with their delivery of the BAI.
| Study group | Role | What they receive |
|---|---|---|
| Facilitation Only (FAC) | Active comparator | Clinics randomized to the FAC arm will implement BAI delivery to PWH using the facilitation only approach. Receives: Other: Facilitation (FAC) |
| Facilitation Plus an Experiential Brief Alcohol Intervention (EBAI+FAC) | Experimental | Clinics randomized to the EBAI+FAC arm will implement BAI delivery to PWH participants using the facilitation approach. Additionally, clinic staff, irrespective of their own alcohol use, will be offered the BAI themselves prior to delivering the BAI. Receives: Other: Facilitation (FAC); Behavioral: Experiential Brief Alcohol Intervention (EBAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidelity Score
Fidelity is a clinic-level measure assessed as a composite of the recipients of the BAI. The timeframe of 15 months reflects individual recruitment over 12 months plus 3 months for completion of the BAI.
The score comprises successful completion of the 4 protocol-specified BAI sessions (2 in-person, 2 by phone) within 7 weeks of the initial session weighted by the central fidelity rater's quality rating of the in-person sessions. Fidelity will be assessed using a tailored selection of fidelity measures including the BAI Core Components Checklist. The clinic fidelity score ranges from 0-100. The score will be the percentage of counseling sessions completed, multiplied (weighted) by the combined average quality rating of counseling sessions. Higher scores indicate higher fidelity.
Measured: 15 months from clinic activation
Viral Suppression
Viral suppression is defined as a viral load <1000 copies/mL on a dried blood spot (DBS) sample collected 12 months after enrollment of a participant.
Measured: 12 months from PWH enrollment
Secondary outcomes (10)
BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale
Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to clinic staff.
Acceptability among clinic staff will be assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items containing responses on a 5-point Likert scale, ranging from 1-4.
The AIM score will be the mean of the 4 item responses (range: 1-5). Higher AIM scores indicate higher acceptability.
Measured: Up to 12 months from clinic activation
BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers
Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to counselors delivering the BAI to patients.
Acceptability among counselor participants will be assessed using the Mental Health Implementation Science Tools (mhIST) Acceptability Scale for providers, which consists of 13 items containing responses on a 4-point Likert scale, ranging from 0-3. The mhIST score is calculated as the mean score of all responses (range: 0-39). Higher mhIST scores indicate higher acceptability.
Measured: Up to 12 months from clinic activation
BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers
Acceptability is the perception that the BAI intervention is agreeable, palatable, or satisfactory to PWH.
Acceptability among PWH participants 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 ranging from 0-3. The mhIST score is calculated as the mean score of all responses (range: 0-45). Higher mhIST scores indicate higher acceptability.
Measured: Up to 12 months from PWH enrollment
Penetration- Proportion of PWH Screened with the AUDIT-C
The first penetration metric will be the proportion of ART clinic visits during the study screening period at which the AUDIT-C is administered
Measured: Up to 12 months from clinic activation
Penetration - Proportion of PWH who screen positive who receive at least one counseling session
The second penetration metric will be the proportion of PWH that screen positive who receive at least one BAI counseling session.
Measured: Up to 12 months from clinic activation
Costs
Investigators will use an "ingredients" or bottom-up approach, with comparison to "top-down" costing. The cost estimates will follow the investigators published conceptual framework for assessing implementation costs and cost analysis of health services. Investigators will include all types of measurable costs (e.g., staff, equipment, consumables, overheads, etc.) associated with key steps and component of the respective implementation strategy and BAI service delivery. Investigators will follow international conventions for all procedures including economic costing, discounting, and reporting.
Measured: Up to 24 months from clinic activation
Sustainability Score: Provider Support of Sustainment Scale (PRESS)
Sustainability will be measured among clinic staff, including directors, using the provider support of sustainment scale (PRESS), a brief, 3-item measure of sustainment that is pragmatic and useable across different evidence-based intervention (EBIs), provider types, and settings. Responses are recorded on a 5-point scale ranging from 0 (not at all) to 4 (to a very great extent) and the score is calculated as the mean of the 3 responses with higher scores indicating higher sustainability. The PRESS captures frontline staff's report of their clinic's continued use of an EBI.
Measured: Up to 24 months from clinic activation
AUDIT (total score) - Clinic staff
Investigators will assess the total Alcohol Use Disorders Identification Test (AUDIT) score. The AUDIT is a 10-item scale with summed responses ranging from 0-40; higher scores indicating more harmful alcohol consumption.
Measured: Up to 24 months from clinic activation
AUDIT (total score) - PWH
Investigators will assess the total Alcohol Use Disorders Identification Test (AUDIT) score. The AUDIT is a 10-item scale with summed responses ranging from 0-40; higher scores indicating more harmful alcohol consumption.
Measured: Up to 12 months from PWH enrollment
Fidelity (Extended Window)
Fidelity is a clinic-level measure assessed as a composite of the recipients of the BAI. The timeframe of 17 months reflects individual recruitment over 12 months plus 5 months for completion of the BAI.
The score comprises successful completion of the 4 protocol-specified BAI sessions (2 in-person, 2 by phone) within 4 months of the initial session weighted by the central fidelity rater's quality rating of the in-person sessions. Fidelity will be assessed using a tailored selection of fidelity measures including the BAI Core Components Checklist. The clinic fidelity score ranges from 0-100. The score will be the percentage of counseling sessions completed, multiplied (weighted) by the combined average quality rating of counseling sessions. Higher scores indicate higher fidelity.
Measured: 17 months from clinic activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start25 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 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 HIV-1-infectionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm cluster-randomized implementation trial comparing two strategies to scale-up an evidence-based brief alcohol intervention (BAI), in Vietnam, examining the mechanisms of BAI scale-up and the impact of experiential BAI (EBAI) on clinic staff. The two implementation approaches are facilitation only (FAC) and facilitation plus an experiential brief alcohol intervention (EBAI+FAC).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,234 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, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Vivian Go, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358885
- Sponsor's protocol ID
- 22-3123
- Other IDs
- R01AA030480
- Acronym
- EBAI
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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
Bartels SM, Phan HTT, Hutton HE, Nhan DT, Sripaipan T, Chen JS, Rossi SL, Ferguson O, Nong HTT, Nguyen NTK, Giang LM, Bui HTM, Chander G, Sohn H, Kim S, Tran HV, Nguyen MX, Powell BJ, Pence BW, Miller WC, Go VF. Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial. Implement Sci. 2024 Jun 12;19(1):40. doi: 10.1186/s13012-024-01368-6.
PubMed 38867283