Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
The Carter Center Ethiopia, Addis Ababa, Ethiopia.
BMJ Open. 2021 Feb 22;11(2):e039529. doi: 10.1136/bmjopen-2020-039529.
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.
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.
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.
(http://www.clinicaltrials.gov): NCT02754583; Pre-results.
尽管缺乏支持水、环境卫生和个人卫生（WASH）措施可降低沙眼传播的有效性的实验证据，但促进面部卫生和改善环境卫生仍是全球消除沙眼战略的核心组成部分。WUHA（阿姆哈拉水卫生改善）试验的目的是评估全面的水改善和卫生教育方案是否可降低非洲农村地区眼部衣原体感染的患病率。
40 个研究集群，每个集群在研究开始前的 7 年内至少每年接受一次大规模阿奇霉素分发，以 1:1 的比例随机分配到 WASH 干预组或延迟 WASH 组。WASH 一揽子计划包括社区供水点、基于社区的卫生促进工作者、家庭洗涤站、家庭 WASH 教育书籍、家庭肥皂分发和小学卫生课程。教育活动强调洗脸和使用厕所。在最初的 3 年内不提供大规模抗生素分发，但在试验的最后 4 年内每年提供。每年在每个社区进行监测访问。主要结局是 0-5 岁儿童眼部衣原体感染的 PCR 证据，每年在一个单独的随机儿童样本中测量 7 年。次要结局是通过结膜摄影评估从基线到最终研究访问时沙眼临床体征的改善。实验室工作人员和照片分级员对治疗分配进行了屏蔽。
研究方案已获得加利福尼亚大学旧金山分校、埃默里大学、埃塞俄比亚食品和药物管理局以及埃塞俄比亚创新和技术部人类受试者审查委员会的批准。一个数据安全和监测委员会监督试验。结果将通过同行评议的出版物和演讲进行传播。
