Clinical trial NCT06358885: IGHID 12230 - An Implementation Trial of an Experiential Brief Alcohol Intervention for HIV Prevention
Official title: IGHID 12230 - Scaling up the Brief Alcohol Intervention to Prevent HIV Infection in Vietnam: a Cluster Randomized, Implementation Trial (EBAI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: National Institutes of Health (NIH)
name: Hanoi Medical University
name: Johns Hopkins University
name: University of Washington
name: Washington University School of Medicine
First posted: 2024-04-11
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Fidelity Score
timeFrame: 15 months
measure: Viral Suppression
timeFrame: 12 months
Secondary outcomes:
measure: BAI Acceptability Score - Clinic Staff: Acceptability of Intervention Measure (AIM) scale
timeFrame: Up to 12 months
measure: BAI Acceptability score Counselors: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Providers
timeFrame: Up to 12 months
measure: BAI Acceptability PWH: Mental Health Implementation Science Tools (mhIST) Acceptability Scale for Consumers
timeFrame: Up to 12 months
measure: Penetration- Proportion of PWH Screened with the AUDIT-C
timeFrame: Up to 12 months
measure: Penetration - Proportion of PWH who screen positive who receive at least one counseling session
timeFrame: Up to 12 months
measure: Costs
timeFrame: Up to 24 months
measure: Sustainability Score: Provider Support of Sustainment Scale (PRESS)
timeFrame: Up to 24 months
measure: AUDIT (total score) - Clinic staff
timeFrame: Up to 24 months
measure: AUDIT (total score) - PWH
timeFrame: Up to 12 months
measure: Fidelity (Extended Window)
timeFrame: 17 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
affiliation: University of North Carolina
name: Vivian Go, MD
role: PRINCIPAL_INVESTIGATOR
References: