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

University of North Carolina (UNC)

Status: Active, not recruiting

Conditions: HIV-1-infection; Unhealthy Alcohol Use

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06358885

R01AA030480 (U.S. NIH Grant/Contract)

22-3123

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

3,234 participants in 2 patient groups

Facilitation Only (FAC)

Active Comparator group

Description:

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

Treatment:

Other: Facilitation (FAC)

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

Experimental group

Description:

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.

Treatment:

Behavioral: Experiential Brief Alcohol Intervention (EBAI)

Other: Facilitation (FAC)