Lover Andrew A, Dantzer Emily, Hocini Sophia, Estera Ronaldo, Rerolle Francois, Smith Jennifer L, Hwang Jimee, Gosling Roly, Yukich Joshua, Greenhouse Bryan, Jacobson Jerry, Phetsouvanh Rattanaxay, Hongvanthong Bouasy, Bennett Adam
Department of Biostatistics and Epidemiology; School of Public Health and Health Sciences, University of Massachusetts- Amherst, Amherst, Massachusetts, 01003-9304, USA.
Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, San Francisco, CA, 94158, USA.
Gates Open Res. 2019 Dec 17;3:1730. doi: 10.12688/gatesopenres.13088.1. eCollection 2019.
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). 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 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 prevalence after one year of implementation. Secondary outcomes include malaria incidence; interventional coverage; operational feasibility and acceptability; and cost and cost- effectiveness. 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. clinicaltrials.gov NCT03783299 (21/12/2018).
需要采取新的干预措施来加速疟疾消除，特别是在无症状寄生虫血症普遍存在且传播通常发生在以村庄为基础的环境之外的地区。由于当前即时检测的灵敏度有限，在先前的研究中，对与临床疾病患者相关的社区成员进行检测（反应性病例检测，RACD）并未显示出有效性。本研究旨在评估在老挝人民民主共和国（老挝）使用新型高灵敏度快速诊断检测在以村庄为基础和以森林为基础的环境中进行主动病例发现的有效性。本研究是一项整群随机裂区设计试验。干预措施包括以村庄为基础的大规模检测和治疗（MTAT）、对高危人群进行重点检测和治疗（FTAT）以及这些方法的组合，使用高灵敏度快速诊断检测（HS-RDTs）来评估感染状况。在老挝占巴塞省的四个区中，14个卫生中心服务区域将被随机分为FTAT组或对照组；在这些卫生中心服务区域内，56个村庄将被随机分为MTAT组或对照组。在干预地区，FTAT将由社区同行导航员定期进行，并计划进行三轮单独的MTAT。主要研究结果将是实施一年后基于PCR的患病率。次要结果包括疟疾发病率；干预覆盖率；操作可行性和可接受性；以及成本和成本效益。研究结果将在clinicaltrials.gov上报告，在同行评审的出版物中报告，并通过与老挝卫生部和社区领导人以及整个大湄公河次区域的利益相关者会议报告。clinicaltrials.gov NCT03783299（2018年12月21日）
