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
Stephen Jan,
Nick Glozier,
Andrew Dawson,
Nicholas Buckley,
Sisira Siribaddana,
Jane Brandt Soerensen,
Thilini Rajapakse,
Jacques Raubenheimer,
Paul S Haber,
Katherine Conigrave,
Angela J Dawson,
Melissa Pearson,
Flemming Konradsen,
Palitha Abeykoon,
Lalith Senerathna,
K S Kylie Lee,
Pahala Hangidi Gedara Janaka Pushpakumara,
Ranil Abeysinghe,
Prabash Siriwardhana,
Chamil Priyadarshana,
Monika Dzidowska
Affiliations
Stephen Jan
The George Institute for Global Health, Newtown, New South Wales, Australia
Nick Glozier
University of Sydney Brain and Mind Research Institute, Sydney, New South Wales, Australia
Andrew Dawson
Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
Nicholas Buckley
South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka
Sisira Siribaddana
Department of Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura, Sri Lanka
Jane Brandt Soerensen
Global Health Section, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
Thilini Rajapakse
South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka
Jacques Raubenheimer
Biomedical Informatics and Digital Health, University of Sydney, Sydney, New South Wales, Australia
Paul S Haber
Sydney Medical School, Royal Prince Albert Hospital, Camperdown, New South Wales, Australia
Katherine Conigrave
Sydney Medical School, Royal Prince Albert Hospital, Camperdown, New South Wales, Australia
Angela J Dawson
Faculty of Health, World Health Collaborating Centre, University of Technology, Sydney, Sydney, New South Wales, Australia
Melissa Pearson
5 Central Clinical School, Faculty of Medicine, The University of Sydney, Sydney, New South Wales, Australia
Flemming Konradsen
4 Global Health Section, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Palitha Abeykoon
National Authority on Tobacco and Alcohol, Colombo, Sri Lanka
Lalith Senerathna
Department of Health Promotion, Faculty of Applied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka
K S Kylie Lee
NHMRC Centre of Research Excellence in Indigenous Health and Alcohol, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
Pahala Hangidi Gedara Janaka Pushpakumara
South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka
Ranil Abeysinghe
Department of Psychiatry, Faculty of Medicine, University of Peradeniya, Peradeniya, Sri Lanka
Prabash Siriwardhana
South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka
Chamil Priyadarshana
South Asian Clinical Toxicology Research Collaboration, University of Peradeniya, Peradeniya, Sri Lanka
Monika Dzidowska
NHMRC Centre of Research Excellence in Indigenous Health and Alcohol, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
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.
