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.

Paediatric poisoning in rural Sri Lanka: an epidemiological study.

BACKGROUND: Acute paediatric poisoning is a common public health concern for both developed and developing countries. The type of agent and underlying cause differ depending on the social, cultural, economic and educational background. The objectives of this study were to identify the incidence and pattern of paediatric poisoning in a rural district in Sri Lanka and establish whether tertiary referral hospital data are a useful surrogate for estimating district level epidemiology of paediatric poisoning. METHODS: A subset of epidemiological data were obtained from March 2011 to February 2013 from a randomized controlled trial (SLCTR/2010/008) conducted in 45 hospitals in Kurunegala district. RESULTS: The age adjusted annual incidence of all cause of acute poisoning in children aged 1 to 12 years in the study area was 60.4 per 100,000. The incidence of poisoning of younger age group (1 to 6 years; 76 per 100,000) was significantly higher than older age group (7 to 12 years; 41 per 100,000) (p = 0.0001) in Kurunegala district. The annual incidence rate of paediatric admissions due to deliberate self-poisoning is 18 per 100,000 population. This study also established that admission data from primary hospitals provided the most accurate epidemiological information on paediatric poisoning. CONCLUSIONS: In rural districts of Sri Lanka, acute paediatric poisoning cases were less frequent and less severe compared to adult poisoning cases (426-446 per 100,000 population). The incidence of poisoning was significantly higher among young children with compared to old children. In this study, deliberate self-poisoning among older children was more frequently seen than in other comparable countries. Because most of the admissions are directed to and managed by primary hospitals, data from referral hospitals alone cannot be used to represent the true incidence of acute poisoning within a district. The data set from all the primary hospitals (n = 44) yielded more accurate poisoning incidence amongst a paediatric population.