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

小结 沙眼是由眼部衣原体感染引起的，是全世界最常见的致盲传染病。 世界卫生组织建议消除沙眼的安全策略：手术治疗内翻 睫毛，大量分发抗生素，以减轻社区衣原体感染的负担，以及面部 清洁和改善环境，以减少眼部衣原体的传播。然而，几乎没有 来自随机试验的证据支持安全策略中的“F”和“E”部分。 目前的研究被称为乌哈II，是乌哈I试验的继续。哇哈I是一个持续的星系团- 埃塞俄比亚农村地区旨在确定水、卫生设施和个人卫生有效性的随机试验 (洗涤)治疗沙眼。40个社区以1：1的比例随机进行了全面的清洗 要么打包，要么不干预。主要结果是眼部衣原体感染，每年监测3年。 在乌哈二期，我们将在一个月后向所有40个乌哈社区大规模分发阿奇霉素 36次访问，然后只在最初随机分配到 洗手。我们在48个月、60个月、72个月和84个月进行年度监测访问，以了解 0~5岁儿童眼衣原体感染情况。二次转归包括临床活动性沙眼 结膜照相，定量聚合酶链式反应的衣原体载量，衣原体的血清学测试，以及 鼻咽部大环内酯类耐药性，每个评估在0-5岁的儿童。无哈二号的第二个目标是 对已经进行的测试以及几种新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、医疗点核酸扩增测试。 在结膜拭子上进行，在干血点上进行衣原体血清阳性的侧向流动试验， 以及一种自动算法，从结膜照片中检测沙眼的临床症状。初级阶段 第二个目的是测试每一种沙眼监测试验的敏感性和特异性。 通过比较阿奇霉素联合洗涤社区和大量接受阿奇霉素的社区 单独地，我们调查将安全策略的“A”、“F”和“E”组件组合为 反对只关注抗生素。考虑到洗衣的费用，这是一个重要的问题 干预措施和沙眼方案有限的资源。《乌哈2》还提供了关于小说的信息 沙眼监测测试，随着世界接近消灭，这将变得更加关键。

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.