Keywords: Fidelity

Abstract:

Background

Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use.

Methods

Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI.

Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months.

Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm.

Discussion

This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases.

Trial Registration

NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885.

Contributions to the literature

• This study tests a novel implementation strategy to educate ART providers and address their attitudes and knowledge about alcohol use and treatment in Vietnam. Few implementation strategies are grounded in an experiential approach to changing provider attitudes and behaviors in contexts where these behaviors are pervasive.
• It uses mixed-methods to determine mechanisms influencing scale-up of the brief alcohol intervention (BAI) to inform future implementation of alcohol interventions for people with HIV across settings where alcohol is normalized.
• It assesses resource-related costs associated with the experiential BAI (EBAI) and EBAI implementation, which can inform policymakers working to prevent HIV transmission.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}