Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

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. Supplementary Information The online version contains supplementary material available at 10.1186/s13012-024-01368-6.

Inclusion: Development of plan, preparation of guidelines and related documents, contacting partners and logistics issues for conducting FGDs, analyzing the data with software and synthesis of findings for inputs of next steps of BAI manual adaptation.

Qualtrics survey
Qualtrics is an online survey tool (free) built to collect information to assess acceptability of the intervention and site context.
The central team sends to health worker participants the link of Qualtrics via email.They are completing the consent form at pre-training survey and surveys at pre and post training, 3-, 12-and 24-month post-implementation.The PTD is a software that collects research data and tracks the study progress of participants.
Inclusion: This activity includes developing requirements, testing PTD software, and operating it.
-Data management staff of UNC will develop requirements for the PTD software.-The PTD software will be built by an outsourced IT company based on those requirements.-UNC staff will check the operation of the software and find out any errors, then respond to the IT company to fix them until all the errors are resolved.The central team will conduct regional group calls with ART clinics every 2 months to address barriers during the intervention implementation and share experiences as well as lessons learned.
Inclusion: Development of plan/guidelines/reporting forms, conduction of these calls and other related procedures.
100% Programma$c UNC VN Technical assistance for clinic staff for delivering BAI to PWH par$cipants The central team will provide technical support for clinic staff at ART clinics regarding interven$on delivery for PWH par$cipants per requests.

Mee1ng
Team mee$ngs for study progress Team mee$ngs are held for upda$ng the study progress among the central team members (UNC, HMU and VAAC) or between the central team and stakeholders (provincial DOH and CDC, site leaders and staffs) or between Vietnam team and US team (not recorded hours mee$ng for US team) Determined by mee$ng agendees UNC, HMU, VAAC Inclusion: Mee$ngs related to EBAI implementa$on including discussion on specific topic e.g., planning, revising study tools, BAI manual, technical issues Exclusion: Mee$ngs on the research issues; (Cost effec$veness, AEs/SAEs/SIs, DSMB, data collec$on and analysis)

Non-monitoring Site visit
Ini$al site visit and assessment The purpose of initial site visit and assessment is to 1) collect basic information about HIV/AIDS related services and processes at EBAI study sites; 2) introduce EBAI study to provincial CDC and sites; 3) discuss collaboration mechanism; 4) identify potential key staff to work with the study; 5) understand barriers influencing the intervention implementation and initially identify strategies to address them.
This helps to understand the context of sites and routine SOPs at sites at pre-implementation for site randomization.

Inclusion:
-Development of site assessment tools and guidelines for site visits -Data collection/entry/cleaning -Logistics issues and team meetings for sharing information on site visits and writing reports.
Intervention manual is revised in adaptive phase in accordance with IDIs and FGDs results.
These training include development/revision of plan, training materials/tools, administra$ve/logis$c assignments, training deployment, mee$ngs for prepara$on and reports.Content of these training materials will be solely for the interven$on implementa$on.Thus, 100% $me would be allocated for the programma$c component.