一项群组随机对照析因设计试验的研究方案，旨在评估反应性局部大规模药物给药和病媒控制在纳米比亚低疟疾流行地区减少疟疾传播的有效性和可行性。
Study protocol for a cluster randomised controlled factorial design trial to assess the effectiveness and feasibility of reactive focal mass drug administration and vector control to reduce malaria transmission in the low endemic setting of Namibia.
作者信息
Medzihradsky Oliver F, Kleinschmidt Immo, Mumbengegwi Davis, Roberts Kathryn W, McCreesh Patrick, Dufour Mi-Suk Kang, Uusiku Petrina, Katokele Stark, Bennett Adam, Smith Jennifer, Sturrock Hugh, Prach Lisa M, Ntuku Henry, Tambo Munyaradzi, Didier Bradley, Greenhouse Bryan, Gani Zaahira, Aerts Ann, Gosling Roly, Hsiang Michelle S
机构信息
Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California, USA.
Department of Pediatrics, Benioff Children's Hospital, University of California San Francisco, San Francisco, California, USA.
出版信息
BMJ Open. 2018 Jan 27;8(1):e019294. doi: 10.1136/bmjopen-2017-019294.
INTRODUCTION
To interrupt malaria transmission, strategies must target the parasite reservoir in both humans and mosquitos. Testing of community members linked to an index case, termed reactive case detection (RACD), is commonly implemented in low transmission areas, though its impact may be limited by the sensitivity of current diagnostics. Indoor residual spraying (IRS) before malaria season is a cornerstone of vector control efforts. Despite their implementation in Namibia, a country approaching elimination, these methods have been met with recent plateaus in transmission reduction. This study evaluates the effectiveness and feasibility of two new targeted strategies, reactive focal mass drug administration (rfMDA) and reactive focal vector control (RAVC) in Namibia.
METHODS AND ANALYSIS
This is an open-label cluster randomised controlled trial with 2×2 factorial design. The interventions include: rfMDA (presumptive treatment with artemether-lumefantrine (AL)) versus RACD (rapid diagnostic testing and treatment using AL) and RAVC (IRS with Acellic 300CS) versus no RAVC. Factorial design also enables comparison of the combined rfMDA+RAVC intervention to RACD. Participants living in 56 enumeration areas will be randomised to one of four arms: rfMDA, rfMDA+RAVC, RACD or RACD+RAVC. These interventions, triggered by index cases detected at health facilities, will be targeted to individuals residing within 500 m of an index. The primary outcome is cumulative incidence of locally acquired malaria detected at health facilities over 1 year. Secondary outcomes include seroprevalence, infection prevalence, intervention coverage, safety, acceptability, adherence, cost and cost-effectiveness.
ETHICS AND DISSEMINATION
Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with MoHSS and community leaders in Namibia.
TRIAL REGISTRATION NUMBER
NCT02610400; Pre-results.
引言
为了阻断疟疾传播，相关策略必须针对人类和蚊子体内的寄生虫宿主。对与索引病例相关的社区成员进行检测，即反应性病例检测（RACD），在低传播地区普遍实施，但其效果可能受到当前诊断方法敏感性的限制。疟疾季节前进行室内滞留喷洒（IRS）是病媒控制工作的基石。尽管纳米比亚已采用这些方法并接近消除疟疾，但近期传播减少出现了停滞。本研究评估了纳米比亚两种新的靶向策略，即反应性集中群体药物管理（rfMDA）和反应性集中病媒控制（RAVC）的有效性和可行性。
方法与分析
这是一项采用2×2析因设计的开放标签整群随机对照试验。干预措施包括：rfMDA（使用蒿甲醚 - 本芴醇（AL）进行推定治疗）与RACD（使用AL进行快速诊断检测和治疗），以及RAVC（使用Acellic 300CS进行IRS）与无RAVC。析因设计还能比较联合的rfMDA + RAVC干预与RACD。居住在56个普查区的参与者将被随机分配到四个组之一：rfMDA、rfMDA + RAVC、RACD或RACD + RAVC。这些干预措施由医疗机构检测到的索引病例触发，将针对居住在索引病例500米范围内的个体。主要结局是在1年内医疗机构检测到的本地获得性疟疾的累积发病率。次要结局包括血清阳性率、感染率、干预覆盖率、安全性、可接受性、依从性、成本和成本效益。
伦理与传播
研究结果将在clinicaltrials.gov上报告，在同行评审出版物中发表，并通过与纳米比亚卫生和社会服务部以及社区领袖的利益相关者会议进行传播。
试验注册号
NCT02610400；预结果。
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