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

• Type of Material: Article
• Authors: Dionna M Wittberg, University of California San Francisco; Solomon Aragie, The Carter Center Ethiopia; Wondyifraw Tadesse, Catholic Relief Service; Jason S Melo, University of California San Francisco; Kristen Aiemjoy, University of California San Francisco; Melsew Chanyalew, Amhara Regional Health Bureau; Paul Emerson, Emory University; Matthew Freeman, Emory University; Scott Nash, Emory University; Elizabeth Callahan, Emory University; Zerihun Tadesse, The Carter Center Ethiopia; Mulat Zerihun, The Carter Center Ethiopia; Travis C Porco, University of California San Francisco; Thomas M Lietman, University of California San Francisco; Jeremy D Keenan, University of California San Francisco
• Language: English
• Date: 2021-01-01
• Publisher: BMJ PUBLISHING GROUP
• Publication Version: Final Published Version
• Copyright Statement: © Author(s) (or their employer(s)) 2021
• License: Creative Commons Attribution-NonCommercial 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1136/bmjopen-2020-039529
• Title of Journal or Parent Work: BMJ OPEN
• Volume: 11
• Issue: 2
• Start Page: e039529
• End Page: e039529
• Grant/Funding Information: This work was supported by grant U10EY023939 from the National Institutes of Health–National Eye Institute (Bethesda, MD, USA); grant NTDSC 062 from the Coalition for Operational Research on Neglected Tropical Diseases (COR-NTD, funded at The Task Force for Global Health primarily by the Bill & Melinda Gates Foundation, the UK Department for International Development, and the US Agency for International Development through its Neglected Tropical Diseases Program; Atlanta, GA, USA), Soapbox Soaps, grant N/A (Alexandria, VA, USA); Carpenter Elementary School, grant N/A (Park Ridge, IL, USA); the JaMel and Tom Perkins Family Foundation, grant N/A (San Francisco, CA, USA); John P Whitcher, grant N/A (San Francisco, CA, USA); That Man May See, grant N/A (San Francisco, CA, USA); Research to Prevent Blindness, grant N/A (New York, NY, USA); and Abbott Laboratories, grant N/A (Abbott Park, IL) through the donation of chlamydia testing analysis kits.
• Keywords: corneal and external diseases; public health; Life Sciences & Biomedicine; preventive medicine; epidemiology; community child health; Medicine, General & Internal; tropical medicine; Science & Technology; General & Internal Medicine
• Research Categories: Environmental Sciences; Health Sciences, Public Health

Abstract

Introduction Facial 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 analysis Forty 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 dissemination Study 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 publications and presentations.