IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention

NCT ID: NCT06358885

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2026-11-30

Brief 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. 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.

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Facilitation Only (FAC)

Clinics randomized to the FAC arm will implement BAI delivery to PWH using the facilitation only approach.

Group Type: ACTIVE_COMPARATOR

Facilitation (FAC)

Intervention Type: 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.

Facilitation Plus an Experiential Brief Alcohol Intervention (EBAI+FAC)

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.

Group Type: EXPERIMENTAL

Facilitation (FAC)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

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.

Interventions

Facilitation (FAC)

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.

Intervention Type: OTHER

Experiential Brief Alcohol Intervention (EBAI)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Clinic staff participants:

• Work at the ART clinic as a clinic director, physician, nurse, or counselor
• Willing to provide informed consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Hanoi Medical University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian Go, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

Hanoi Medical University

Hanoi, , Vietnam

Countries

Vietnam

References

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.

Reference Type: DERIVED

PMID: 38867283 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AA030480

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-3123

Identifier Type: -

Identifier Source: org_study_id