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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.<\/jats:p>\n <\/jats:sec>\n \n Methods and analysis<\/jats:title>\n 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.<\/jats:p>\n 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\u2013post 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.<\/jats:p>\n <\/jats:sec>\n \n Ethics and dissemination<\/jats:title>\n The original study and amendments have been reviewed and granted ethical approval by Rajarata University of Sri Lanka (ERC\/2018\/21\u2014July 2018 and February 2022) and the University of Sydney (2019\/006). Findings will be disseminated locally in collaboration with the community and stakeholders.<\/jats:p>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n \n The trial is registered with the Sri Lanka Clinical Trials Registry;\n https:\/\/slctr.lk\/trials\/slctr-2018-037<\/jats:ext-link>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-064722","type":"journal-article","created":{"date-parts":[[2023,6,15]],"date-time":"2023-06-15T12:45:48Z","timestamp":1686833148000},"page":"e064722","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["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 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