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临床试验/NCT02878200
NCT02878200已完成不适用

Reactive Household-based Self-administered Treatment Against Residual Malaria Transmission: a Cluster Randomized Trial

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 2,236 人开始时间: 2016年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,236
试验地点
1
主要终点
prevalence of malaria infection

研究概览

简要总结

Reactive treatment of household contacts of a confirmed malaria case has been shown to reduce infection prevalence since the former as they are at an increased risk of infection. However, implementing this on a programmatic scale poses significant pressure on the health system and may not be sustainable without the active involvement of the recipient community. This study investigates a novel approach to reducing residual malaria transmission that combines the elements of active community involvement in reactive treatment of household contacts of a clinical case reporting at a health facility. The investigators hypothesize that in areas of low transmission (prevalence of infection ≤10%), most asymptomatic carriers are clustered around clinical malaria cases in the same households. Also, targeting individuals sharing a sleeping area with diagnosed malaria case will reduce parasite carriage in the community. This is a cluster-randomized trial where villages in Central and Upper Baddibu, North Bank East Region of The Gambia, are randomized to receive either reactive treatment of household contacts following a confirmed case of malaria or standard care, i.e. treatment of index case only. Formative research into community perception and reaction to self-administered treatment will be used to generate, adapt and evaluate messages that encourage adherence and compliance to treatment. This will be tested in the first year of the implementation, and findings used to develop a final model of messages to be implemented in the second year of the study. The primary outcome is the prevalence of malaria infection, determined by molecular methods, in all age groups at the end of the second intervention year and the incidence of clinical malaria during the transmission season.

详细描述

Achieving malaria elimination presents a challenge because of important gaps in the knowledge about the strategies and tools needed achieve this. While malaria control measures aim to reduce morbidity and mortality in vulnerable populations, interventions to reduce transmission are designed to interrupt transmission of malaria parasites from humans, especially asymptomatic parasite carriers [1], to mosquitoes.

The importance of asymptomatic infections in transmission has grown with the awareness that the majority of the human reservoir of infection are asymptomatic carriers [2] and these are quite difficult to target [3]. Previous malaria elimination campaigns have applied a strategy of mass drug administration: extensive treatment of entire populations, irrespective of their infection status, in one or multiple rounds [4]. Although transmission was interrupted in some cases, albeit temporarily [5], there is a reluctance to apply this method because the evidence of its impact has been mixed. A Cochrane systematic review of MDAs showed that long term reductions were not possible within the current concept and highlighted the need for studies in low- and moderate-transmission settings and studies that could address potential barriers for community uptake, and contribution to the development of drug resistance [6].

More conservative approaches involving screening for infection with a rapid malaria diagnostic test (RDT) and treating only positive individuals; mass screening and treatment, did not have a significant impact on the malaria incidence [7], largely due to low test's sensitivity that would miss a large proportion of infected individuals with low parasite densities. Implementing reactive screening on a programmatic scale puts significant pressure on the health system [8] and available field-based screening tests lack the required sensitivity for low-density parasitaemia seen with asymptomatic infections [9]. More importantly, understanding the local context and adapting intervention strategies may help improve coverage and participation by recipient communities [10].

This study investigates a novel approach to reducing residual malaria transmission that combines the elements of reactive treatment of household contacts of a clinical case reporting at a health facility with the active involvement of both patients and their households. The approach to implementation will be developed through formative research that identifies the optimum means of community engagement that will result in the best possible compliance and adherence to the treatment in the household.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Resident in the study area for at least two weeks
  • Informed consent to participate in the trial
  • willing to receive DHAP (intervention villages)
  • Age ≥6 months and weight ≥5kg*

排除标准

  • Pregnancy (first trimester only)†
  • Known allergies to DHAP
  • Known chronic cardiac disease

结局指标

主要结局

prevalence of malaria infection

时间窗: 24 months

the prevalence of malaria infection (determined by molecular methods) in all age groups at the end of the second intervention year

次要结局

  • prevalence of clinical (laboratory confirmed) malaria cases(3-4 months)
  • the prevalence of antimalarial drug resistance molecular markers(4 months and 16 months)
  • treatment coverage(4 months and 16 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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