Evaluating the programme and behavior change theories of a community alcohol education intervention in rural Sri Lanka: a study protocol.

Risky alcohol use is a major public health problem globally and in Sri Lanka. While a reduction in alcohol consumption can result in physical, mental, and social benefits, behaviour change is difficult to achieve. Effective, context-adapted interventions are required to minimise alcohol-related harm at a community level. THEATRE is a complex, community-based intervention evaluating whether a promising Sri Lankan pilot study that utilised arts-based research to moderate alcohol use can be scaled up. While the scaled-up pilot study protocol is presented elsewhere, the aim of this protocol paper is to describe the intervention programme theory and evaluation design, and modifications made to the study resulting from COVID-19 and the financial crisis. Drawing on the Behaviour Change Wheel (BCW) and Theoretical Domains Framework, behaviour change theories are presented with potential pathways to guide implementation and evaluation. Alcohol consumption patterns and context of drinking is detailed. The multifaceted intervention targets individuals and communities using arts-based interventions. Four of nine BCW functions are employed in the design of the intervention: education, persuasion, modelling and enablement, and training. Modifications made to the study due to COVID-19 and the financial crisis are described. Ethical approval was obtained from the Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and Feb 2022) and the University of Sydney (2019/006). Findings will be disseminated locally to community members and key stakeholders and via international peer-reviewed publications.

Community-based alcohol education intervention (THEATRE) study to reduce harmful effects of alcohol in rural Sri Lanka: design and adaptation of a mixed-methods stepped wedge cluster randomised control trial.

INTRODUCTION: Alcohol consumption is a leading cause of mortality, morbidity and adverse social sequelae in Sri Lanka. Effective community-based, culturally adapted or context-specific interventions are required to minimise these harms. We designed a mixed-methods stepped wedge cluster randomised control trial of a complex alcohol intervention. This paper describes the initial trial protocol and subsequent modifications following COVID-19. METHODS AND ANALYSIS: We aimed to recruit 20 villages (approximately n=4000) in rural Sri Lanka. The proposed intervention consisted of health screening clinics, alcohol brief intervention, participatory drama, film, and public health promotion materials to be delivered over 12 weeks.Following disruptions to the trial resulting from the Easter bombings in 2019, COVID-19 and a national financial crisis, we adapted the study in two main ways. First, the interventions were reconfigured for hybrid delivery. Second, a rolling pre-post study evaluating changes in alcohol use, mental health, social capital and financial stress as the primary outcome and implementation and ex-ante economic analysis as secondary outcomes. ETHICS AND DISSEMINATION: The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC/2018/21-July 2018 and February 2022) and the University of Sydney (2019/006). Findings will be disseminated locally in collaboration with the community and stakeholders.The new hybrid approach may be more adaptable, scalable and generalisable than the planned intervention. The changes will allow a closer assessment of individual interventions while enabling the evaluation of this discontinuous event through a naturalistic trial design. This may assist other researchers facing similar disruptions to community-based studies. TRIAL REGISTRATION: The trial is registered with the Sri Lanka Clinical Trials Registry; https://slctr.lk/trials/slctr-2018-037.