Sanitation, Water, and Instruction in face-washing for trachoma II (SWIFT II)

简要总结 沙眼由眼衣原体感染引起，是世界范围内最常见的致盲性传染病。 世界卫生组织推荐消除沙眼的安全策略： 睫毛，大规模分发抗生素，以减少衣原体感染的社区负担， 清洁和环境改善，以减少眼部衣原体的传播。不过小 来自随机试验的证据支持SAFE战略的“F”和“E”部分。 本研究称为WUHA II，是WUHA I试验的延续。WUHA I是一个正在进行的集群- 在埃塞俄比亚农村进行的一项随机试验，旨在确定水、环境卫生和个人卫生的有效性 （WASH）用于沙眼。40个社区以1：1的比例随机分配到一个全面的WASH 包或不干预。主要结果是眼衣原体，每年监测3年。 在WUHA II中，我们将在一个月后对所有40个WUHA社区进行单次大规模阿奇霉素分发 36次访问，然后仅在最初随机分配到 我们在48、60、72和84个月进行年度监测访视，主要结局是： 0-5岁儿童眼部衣原体感染情况。次要结果包括临床活动性沙眼， 结膜照相、定量PCR的衣原体载量、衣原体血清学检测，以及 鼻咽大环内酯类耐药性，每种都在0-5岁儿童中进行评估。WUHA II的第二个目标是 对已经进行的测试以及几种新的测试进行诊断测试准确性研究 用于沙眼监测。新的测试包括廉价的即时核酸扩增测试 在结膜拭子上进行，在干血斑上测试衣原体血清阳性的侧流测定， 以及从结膜照片中检测沙眼临床体征的自动算法。主 第二个目标是测试这些沙眼监测测试中的每一种的灵敏度和特异性。 通过比较联合阿奇霉素-WASH社区与接受大规模阿奇霉素的社区， 单独来看，我们研究了将SAFE战略的“A”、“F”和“E”组成部分结合起来的好处， 而不是仅仅关注抗生素。考虑到讲卫生运动的费用，这是一个重要的问题 干预措施和沙眼项目资源有限。WUHA II还提供了有关小说的信息 沙眼监测测试，这将变得更加重要，因为世界接近消除。

BRIEF SUMMARY Trachoma, caused by ocular chlamydia infection, is the most common infectious cause of blindness worldwide. The World Health Organization recommends the SAFE strategy for trachoma elimination: Surgery for inturned eyelashes, mass Antibiotic distributions to reduce the community burden of chlamydial infection, and Facial cleanliness and Environmental improvements to reduce transmission of ocular chlamydia. However, little evidence from randomized trials exists to support the “F” and “E” components of the SAFE strategy. The present study, called WUHA II, is a continuation of the WUHA I trial. WUHA I is an ongoing cluster- randomized trial in rural Ethiopia designed to determine the effectiveness of water, sanitation, and hygiene (WASH) for trachoma. 40 communities were randomized in a 1:1 ratio either to a comprehensive WASH package or to no intervention. The primary outcome is ocular chlamydia, monitored annually for 3 years. In WUHA II we will treat all 40 WUHA communities with a single mass azithromycin distribution after the month 36 visit, and then continue the WASH intervention only in the 20 communities originally randomized to the WASH arm. We perform annual monitoring visits at months 48, 60, 72, and 84 for the primary outcome of ocular chlamydia among 0-5 year old children. Secondary outcomes include clinically active trachoma from conjunctival photography, chlamydial load from quantitative PCR, serologic tests for chlamydia, and nasopharyngeal macrolide resistance, each assessed in children aged 0-5 years. A second aim of WUHA II is to perform a diagnostic test accuracy study of the tests already being conducted as well as several novel tests for trachoma surveillance. The novel tests include inexpensive, point-of-care nucleic acid amplification tests performed on conjunctival swabs, a lateral flow assay for chlamydia seropositivity tested on dried blood spots, and an automated algorithm to detect clinical signs of trachoma from conjunctival photographs. The primary objective of the second aim is to test the sensitivity and specificity of each of these trachoma surveillance tests. By comparing the combined azithromycin-WASH communities to communities receiving mass azithromycin alone, we investigate the benefit of combining the “A”, “F”, and “E” components of the SAFE strategy as opposed to focusing on antibiotics alone. This is an important question given the expense of WASH interventions and the limited resources of trachoma programs. WUHA II also provides information on novel trachoma surveillance tests, which will become more crucial as the world nears elimination.