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

NCT06358885 | Active Not Recruiting

• 2 other identifiers: 22-3123R01AA030480
• Study Type: interventional
• Target: 3,234
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  15 months

• 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.

  12 months

Secondary Outcomes (10)

• BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale

  Up to 12 months

• BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers

  Up to 12 months

• BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers

  Up to 12 months

• Penetration- Proportion of PWH Screened with the AUDIT-C

  Up to 12 months

• Penetration - Proportion of PWH who screen positive who receive at least one counseling session

  Up to 12 months

Study Arms (2)

Facilitation Only (FAC)

ACTIVE COMPARATOR

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

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.

Other: Facilitation (FAC); Behavioral: Experiential Brief Alcohol Intervention (EBAI)

Interventions

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.

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

Experiential Brief Alcohol Intervention (EBAI) 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: collaborator
• Washington University School of Medicine: collaborator
• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• National Institutes of Health (NIH): collaborator
• Hanoi Medical University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Hanoi Medical University

Hanoi, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 38867283 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Vivian Go, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

VN (1)