Study protocol for a cluster-randomized split-plot design trial to assess the effectiveness of targeted active malaria case detection among high-risk populations in Southern Lao PDR (the AcME-Lao study).
Study protocol for a cluster-randomized split-plot design trial to assess the effectiveness of targeted active malaria case detection among high-risk populations in Southern Lao PDR (the AcME-Lao study).
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DOI：
10.12688/gatesopenres.13088.1
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发表时间：
2019-01-01
影响因子：
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通讯作者：
Bennett, Adam
中科院分区：
文献类型：
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作者：
Lover, Andrew A;Dantzer, Emily;Bennett, Adam
导言：需要新的干预措施来加速消除疟疾，特别是在无症状寄生虫病常见的地区，以及传播通常发生在村庄以外的地区。对与临床疾病患者有关联的社区成员的检测（反应性病例检测，RACD）在先前的研究中未显示出有效性，因为目前的即时检测灵敏度有限。本研究旨在评估在老挝人民民主共和国（Lao PDR）使用新型高灵敏度快速诊断测试在基于村庄和基于森林的环境中主动发现病例的有效性。方法与分析：本研究采用聚类随机分割图设计试验。这些干预措施包括以村为基础的大规模检测和治疗（MTAT）、高危人群的局部检测和治疗（FTAT），以及这些方法的结合，使用高灵敏度快速诊断检测（HS-RDTs）来评估恶性疟原虫感染状况。老挝人民民主共和国占巴塞省4个县内的14个卫生中心集水区将被随机分配到自由贸易区或对照区；在这些HCCAs内，56个村庄将被随机分配到MTAT或对照组。在干预地区，将由以社区为基础的同伴导航员进行常规的中期评估，并计划进行三轮中期评估。主要研究结果将是实施一年后基于pcr的恶性疟原虫流行情况。次要结局包括疟疾发病率；介入报道;操作的可行性和可接受性；而且成本和性价比高。伦理和传播：调查结果将在临床试验网站、同行评议的出版物中报告，并通过与老挝人民民主共和国和整个大湄公河次区域的卫生部和社区领导人举行的利益攸关方会议进行报告。试验注册：clinicaltrials.gov NCT03783299（21/12/2018）。
Introduction: Novel interventions are needed to accelerate malaria elimination, especially in areas where asymptomatic parasitemia is common, and where transmission generally occurs outside of village-based settings. Testing of community members linked to a person with clinical illness (reactive case detection, RACD) has not shown effectiveness in prior studies due to the limited sensitivity of current point-of-care tests. This study aims to assess the effectiveness of active case finding in village-based and forested-based settings using novel high-sensitivity rapid diagnostic tests in Lao People's Democratic Republic (Lao PDR). Methods and analysis: This study is a cluster-randomized split-plot design trial. The interventions include village-based mass test and treat (MTAT), focal test and treat in high-risk populations (FTAT), and the combination of these approaches, using high-sensitivity rapid diagnostic tests (HS-RDTs) to asses P. falciparum infection status. Within four districts in Champasak province, Lao PDR fourteen health center-catchment areas will be randomized to either FTAT or control; and within these HCCAs, 56 villages will be randomized to either MTAT or control. In intervention areas, FTAT will be conducted by community-based peer navigators on a routine basis, and three separate rounds of MTAT are planned. The primary study outcome will be PCR-based Plasmodium falciparum prevalence after one year of implementation. Secondary outcomes include malaria incidence; interventional coverage; operational feasibility and acceptability; and cost and cost- effectiveness. Ethics and dissemination: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with Ministry of Health and community leaders in Lao PDR and throughout the Greater Mekong Subregion. Trial registration: clinicaltrials.gov NCT03783299 (21/12/2018).