WASH Upgrades for Health in Amhara (WUHA): study protocol for a cluster-randomised trial in Ethiopia.

eScholarship, University of California 2021-02-22

IntroductionFacial hygiene promotion and environmental improvements are central components of the global trachoma elimination strategy despite a lack of experimental evidence supporting the effectiveness of water, sanitation and hygiene (WASH) measures for reducing trachoma transmission. The objective of the WUHA (WASH Upgrades for Health in Amhara) trial is to evaluate if a comprehensive water improvement and hygiene education programme reduces the prevalence of ocular chlamydia infection in rural Africa.Methods and analysisForty study clusters, each of which had received at least annual mass azithromycin distributions for the 7 years prior to the start of the study, are randomised in a 1:1 ratio to the WASH intervention arm or a delayed WASH arm. The WASH package includes a community water point, community-based hygiene promotion workers, household wash stations, household WASH education books, household soap distribution and a primary school hygiene curriculum. Educational activities emphasise face-washing and latrine use. Mass antibiotic distributions are not provided during the first 3 years but are provided annually over the final 4 years of the trial. Annual monitoring visits are conducted in each community. The primary outcome is PCR evidence of ocular chlamydia infection among children aged 0-5 years, measured in a separate random sample of children annually over 7 years. A secondary outcome is improvement of the clinical signs of trachoma between the baseline and final study visits as assessed by conjunctival photography. Laboratory workers and photo-graders are masked to treatment allocation.Ethics and disseminationStudy protocols have been approved by human subjects review boards at the University of California, San Francisco, Emory University, the Ethiopian Food and Drug Authority, and the Ethiopian Ministry of Innovation and Technology. A data safety and monitoring committee oversees the trial. Results will be disseminated through peer-reviewed publica

Humans; Trachoma; Hygiene; Sanitation; Child; Preschool; Infant; Newborn; Ethiopia; San Francisco; Randomized Controlled Trials as Topic; community child health; corneal and external diseases; epidemiology; preventive medicine; public health; tropical medicine; Clinical Research; Patient Safety; Prevention; Eye Disease and Disorders of Vision; Pediatric; Infectious Diseases; Clinical Trials and Supportive Activities; Infection; Clinical Sciences; Public Health and Health Services; Other Medical and Health Sciences; article

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BMJ open vol 11, iss 2, e039529 2044-6055

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