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首页> 外文期刊>Trials >Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia
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Community-led Responses for Elimination (CoRE): a study protocol for a community randomized controlled trial assessing the effectiveness of community-level, reactive focal drug administration for reducing Plasmodium falciparum infection prevalence and incidence in Southern Province, Zambia

机译：社区主导的消除对策（CoRE）：一项社区随机对照试验的研究方案，评估社区级反应性局灶性药物管理在降低赞比亚南部省份恶性疟原虫感染率和发病率方面的有效性

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Zambia is pushing for, and has made great strides towards, the elimination of malaria transmission in Southern Province. Reactive focal test and treat (RFTAT) using rapid diagnostic tests and artemether-lumefantrine (AL) has been key in making this progress. Reactive focal drug administration (RFDA) using dihydroartemisinin-piperaquine (DHAP), may be superior in accelerating clearance of the parasite reservoir in humans due to the provision of enhanced chemoprophylactic protection of at-risk populations against new infections. The primary aim of this study is to quantify the relative effectiveness of RFDA with DHAP against RFTAT with AL (standard of care) for reducing Plasmodium falciparum prevalence and incidence. The study will be conducted in four districts in Southern Province, Zambia; an area of low malaria transmission and high coverage of vector control. A community randomized controlled trial of 16 health facility catchment areas will be used to evaluate the impact of sustained year-round routine RFDA for 2?years, relative to a control of year-round routine RFTAT. Reactive case detection will be triggered by a confirmed malaria case, e.g., by microscopy or rapid diagnostic test at any government health facility. Reactive responses will be performed by community health workers (CHW) within 7?days of the index case confirmation date. Responses will be performed out to a radius of 140?m from the index case household. A subset of responses will be followed longitudinally for 90?days to examine reinfection rates. Primary outcomes include a post-intervention survey of malaria seropositivity (n?=?4800 children aged 1?month to under 5?years old) and a difference-in-differences analysis of malaria parasite incidence, as measured through routine passive case detection at health facilities enrolled in the study. The study is powered to detect approximately a 65% relative reduction in these outcomes between the intervention versus the control. Strengths of this trial include a robust study design and an endline cross-sectional parasite survey as well as a longitudinal sample. Primary limitations include statistical power to detect only a 65% reduction in primary outcomes, and the potential for contamination to dilute the effects of the intervention. ClinicalTrials.gov, ID: NCT02654912 . Registered on 12 November 2015.
机译：赞比亚正在为消除南部省的疟疾传播而努力，并已迈出了一大步。使用快速诊断测试和蒿甲醚-萤石碱（AL）的反应性局灶性测试和治疗（RFTAT）是取得这一进展的关键。使用双氢青蒿素-哌喹（DHAP）进行反应性局灶性药物管理（RFDA），由于可为处于危险中的人群提供预防新感染的增强的化学预防保护，因此在加速清除人体寄生虫库方面可能更为出色。这项研究的主要目的是量化RFDA与DHAP相对于RFTAT与AL（护理标准）在降低恶性疟原虫患病率和发病率方面的相对有效性。这项研究将在赞比亚南部省的四个地区进行;疟疾传播低，病媒控制覆盖率高的地区。将对16个医疗机构集水区进行社区随机对照试验，以评估相对于对全年例行RFTAT的控制，持续全年进行2年例RFDA的影响。确诊的疟疾病例将触发反应性病例检测，例如，在任何政府卫生机构进行显微镜检查或快速诊断检测。社区卫生工作者（CHW）将在索引病例确认日期的7天之内做出反应。将从索引箱的家庭到半径140？m的范围内进行响应。将对一部分反应进行纵向跟踪90天，以检查再感染率。主要结果包括干预后的疟疾血清阳性调查（n == 4800名1个月月龄至5岁以下的儿童）和对疟疾寄生虫发病率的差异分析，该分析通过常规的被动病例检测参与研究的医疗机构。这项研究能够检测到干预与对照之间这些结果的相对减少约65％。该试验的优势包括可靠的研究设计和最终的横断面寄生虫调查以及纵向样品。主要的局限性包括统计能力仅能检测到主要结局减少65％，以及污染的可能性会降低干预效果。 ClinicalTrials.gov，ID：NCT02654912。 2015年11月12日注册。

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