The Carter Center, Atlanta, GA, USA.
Ministry of Health, Juba, Republic of South Sudan.
BMC Ophthalmol. 2023 Feb 6;23(1):51. doi: 10.1186/s12886-023-02783-x.
The World Health Organization targeted trachoma for global elimination as a public health problem by 2030. Reaching elimination thresholds by the year 2030 in the Republic of South Sudan will be a considerable challenge, as the country currently has many counties considered hyper-endemic (> 30% trachomatous inflammation-follicular [TF]) that have yet to receive interventions. Evidence from randomized trials, modeling, and population-based surveys suggests that enhancements may be needed to the standard-of-care annual mass drug administration (MDA) to reach elimination thresholds in a timely manner within highly endemic areas. We describe a protocol for a study to determine the cost and community acceptability of enhanced antibiotic strategies for trachoma in South Sudan.
The Enhancing the A in SAFE (ETAS) study is a community randomized intervention costing and community acceptability study. Following a population-based trachoma prevalence survey in 1 county, 30 communities will be randomized 1:1 to receive 1 of 2 enhanced MDA interventions, with the remaining communities receiving standard-of-care annual MDA. The first intervention strategy will consist of a community-wide MDA followed by 2 rounds of targeted treatment to children ages 6 months to 9 years, 2 weeks and 4 weeks after the community MDA. The second strategy will consist of a community-wide biannual MDA approximately 6 to 8 months apart. The costing analysis will use a payer perspective and identify the total cost of the enhanced interventions and annual MDA. Community acceptability will be assessed through MDA coverage monitoring and mixed-methods research involving community stakeholders. A second trachoma-specific survey will be conducted 12 months following the original survey.
ETAS has received ethical clearance and is expected to be conducted between 2022 and 2023. Results will be shared through subsequent manuscripts. The study's results will provide information to trachoma programs on whether enhanced interventions are affordable and acceptable to communities. These results will further help in the design of future trachoma-specific antibiotic efficacy trials. Enhanced MDA approaches could help countries recover from delays caused by conflict or humanitarian emergencies and could also assist countries such as South Sudan in reaching trachoma elimination as a public health problem by 2030.
This trial was registered on December 1, 2022 (clinicaltrails.org: NCT05634759).
世界卫生组织将沙眼定为 2030 年前全球消除的公共卫生问题。要在 2030 年前达到南苏丹共和国消除的阈值将是一个相当大的挑战，因为该国目前有许多被认为是高度流行地区（>30%沙眼滤泡性[TF]）的县尚未接受干预。随机试验、建模和基于人群的调查证据表明，需要加强标准护理年度大规模药物治疗（MDA），以便在高度流行地区及时达到消除阈值。我们描述了一项研究方案，以确定在南苏丹增强抗生素治疗沙眼的成本和社区可接受性。
增强 SAFE 中的 A（ETAS）研究是一项社区随机干预成本和社区可接受性研究。在一个县进行了基于人群的沙眼患病率调查后，将 30 个社区随机分为 1:1 接受 2 种增强 MDA 干预中的 1 种，其余社区接受标准护理年度 MDA。第一种干预策略将包括社区范围内的 MDA，然后对 6 个月至 9 岁的儿童进行 2 轮有针对性的治疗，在社区 MDA 后 2 周和 4 周进行。第二种策略将包括每隔 6 到 8 个月进行一次社区范围的半年 MDA。成本分析将采用支付者视角，并确定增强干预措施和年度 MDA 的总成本。社区可接受性将通过 MDA 覆盖率监测和包括社区利益相关者的混合方法研究进行评估。在最初调查后的 12 个月内将进行第二次沙眼特异性调查。
ETAS 已获得伦理批准，预计将于 2022 年至 2023 年进行。结果将通过随后的论文分享。该研究的结果将为沙眼规划者提供有关增强干预措施是否对社区负担得起和可接受的信息。这些结果将进一步帮助设计未来的沙眼特异性抗生素疗效试验。增强 MDA 方法可以帮助国家从冲突或人道主义紧急情况造成的延误中恢复，也可以帮助南苏丹等国家在 2030 年前实现沙眼作为公共卫生问题的消除。
该试验于 2022 年 12 月 1 日（clinicaltrails.org：NCT05634759）注册。
