Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial

Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial
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DOI:
10.1136/bmjopen-2019-030598
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发表时间:
2019-09-01
期刊:
影响因子:
2.9
通讯作者:
Tiono, Alfred
Tiono, Alfred
中科院分区:
医学3区
文献类型:
--
作者:
Collins, Katharine A.;Ouedraogo, Alphonse;Tiono, Alfred

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在流行地区,大部分疟疾感染者没有出现促使寻求治疗的症状。这些无症状感染的个体可能会保持感染数月,在此期间产生可能传播给蚊子的有性阶段寄生虫(配子体)。通过及早发现和治疗这些感染,可以减少疟疾传播。本研究评估的影响,加强社区病例管理(CCM)和每月筛查和治疗(MSAT)对疟疾infections.Methods和analysis的患病率和传播率这群集随机试验将发生在萨波内,一个地区的激烈,高度季节性疟疾在布基纳法索。总共有180种化合物将被随机分配到三种干预措施中的一种:第1组-目前的标准护理,被动监测疟疾感染;第2组-标准护理加加强的CCM,包括每周主动筛查发热,以及使用常规快速诊断测试检测和治疗发热阳性个体的感染;或第3组-标准治疗和增强型CCM,加上使用RDT的MSAT。这项研究将在大约18个月内进行,涵盖两个高传播季节和其间的旱季。招募战略旨在确保总体传播和感染力不受影响,以便我们能够在疟疾持续密集传播的背景下不断评估干预措施的影响。该研究的主要目的是确定加强CCM和MSAT对寄生虫血症和配子体血症的流行率和密度以及感染的传播性的影响。这将通过在季节开始和结束时的横断面调查期间对所有研究参与者的感染进行分子检测以及对疟疾阳性个体进行常规采样以评估其对蚊子的感染性来实现。伦理学和传播该研究已经由伦敦卫生和热带医学学院(LSHTM)审查和批准。(审核编号:14724)和国家疟疾研究和培训中心机构审查委员会(IRB)(审议N度2018/000002/MS/SG/CNRFP/CIB)和布基纳法索国家医学伦理委员会(审议N度2018-01-010)。研究结果将通过当地意见领袖和社区会议与社区分享。还可通过会议、研讨会、报告、论文和同行评审出版物分享成果;疾病发生率数据和研究成果将与卫生部分享。数据将在一个在线数字储存库中公布。
Introduction A large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.Methods and analysis This cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.Ethics and dissemination The study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N degrees 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N degrees 2018-01-010).Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.