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临床试验/NCT06225297
NCT06225297暂停4 期

Evaluation of Vector and Chemoprevention-based Interventions to Reduce Malaria Burden in Urban Daaras of Touba, Senegal

PATH1 个研究点 分布在 1 个国家目标入组 4,600 人开始时间: 2024年1月19日最近更新:
适应症

试验速览

阶段
4 期
状态
暂停
发起方
入组人数
4,600
试验地点
1
主要终点
Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms

研究概览

简要总结

This study aims to evaluate the effectiveness of the use of adapted insecticide-treated mosquito nets combined with extended DHA-PQ-based seasonal chemoprevention for all ages and behavior change communication in reducing the burden of malaria in relation to standards of protection and care among students (taalibés) in the daaras (Koranic schools) of Touba, Senegal.

详细描述

In Senegal, young children (mostly boys) may be sent to religious schools (daaras) to learn about the Koran and moral and cultural values. The students (talibés) often live and sleep in crowded conditions and as a result, insecticide-treated net (ITN) use is consistently low due to challenges faced in hanging ITNs as well as difficulty covering multiple children sleeping together. This study will consist of a two-arm cluster-randomized controlled trial to evaluate the effectiveness of an intervention package in urban daaras in Touba City, Diourbel region, Senegal.

The intervention package will include vector control through meganets (multiple insecticide-treated mosquito nets sewn together and adapted based on the needs and sleeping situation of the daara), seasonal malaria chemoprevention (SMC) extended to all ages using DHA-PQ, and behavior change communication.

Prior to evaluating an intervention, there will be 1) a mapping of the daaras in Touba City, Diourbel Region of Senegal to observe the various structures and types of daaras in order to select typical daaras for the entomological component, and to inform randomization, 2) human behavior observation (HBO) of students (talibes) and teachers (marabouts) in 2-3 daaras selected through the mapping to help tailor the intervention package, and 3) analysis of mosquito behavior observed through human landing catches.

Two cross-sectional surveys will be conducted, before and after the intervention, which will include an electronic questionnaire to be sent to the taalibés themselves or to their guardians, a temperature reading, an RDT for participants with a fever at the time of the survey, and a fingertip blood sample to assess parasite prevalence (microscopy and PCR). Qualitative surveys will be carried out using a mixed-method design, consisting of a literature review, in-depth individual interviews, focus groups, and on-site observations. Meganet monitoring surveys will be carried out after meganet distribution to assess the attrition and physical integrity of the nets.

Malaria incidence will be determined from records of community health workers assigned to the daaras who have been trained by the Ministry of Health to identify febrile students, test them for malaria using a rapid diagnostic test and treat confirmed cases with an antimalarial medicine. Additional data on students who seek care from health centers in their neighborhood will supplement the data obtained from community health workers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

Study participants, community health workers, and study field staff will not be blinded to intervention assignment. However, the trial statistician and laboratory technicians carrying out subsequent analyses in reference laboratories will remain blinded.

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in cumulative incidence of clinical malaria confirmed by rapid diagnostic test (RDT) between arms

时间窗: monthly basis over 12 months

Cumulative incidence will be defined as the number of RDT-confirmed malaria cases per 1000 population in each daara. Cases will be identified from both PECAdaara and health facility registries

Difference in change in prevalence of microscopy-confirmed infection between arms

时间窗: 12 months

Prevalence will be defined as the proportion of individuals with microscopy-confirmed infection assessed during the endline survey

Difference in pre-post change in prevalence of PCR-confirmed infection between arms

时间窗: 12 months

Prevalence will be defined as the proportion of individuals with PCR-confirmed infection, assessed during cross-sectional surveys

次要结局

  • Difference in cumulative incidence of grade 3+ adverse events after drug administration between arms(12 months)
  • Difference in the cumulative incidence of serious adverse events (SAE) after SMC administration between arms(12 months)
  • Difference in human behavior on net use before and after ITN/meganet distribution(12 months)
  • Difference in indoor and outdoor adjusted human biting rates between arms(12 months)
  • Difference in Anopheles biting trends between arms(12 months)
  • Acceptability of intervention package(12 months)
  • Difference in proportion of refusals between arms(12 months)
  • Difference in distribution coverage of chemoprevention strategies between arms(12 months)
  • Difference in crude coverage of chemoprevention strategies between arms(12 months)
  • Cost per malaria case averted(12 months)

研究者

发起方
PATH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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