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临床试验/NCT06179732
NCT06179732已完成3 期

Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities:A Cluster Randomised Trial

The Mentor Initiative1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2023年6月5日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
2,400
试验地点
1
主要终点
epidemiological outcome: malaria incidence

研究概览

简要总结

The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.

By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.

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
None

盲法说明

Neither the deliverers of the intervention nor the outcome assessors are blinded to the group allocations.

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Shelters with 1 or more children from 6-10 years old
  • •Shelters with an adult/head of the household

排除标准

  • •Shelters without children from 6-10 years old

研究组 & 干预措施

Control

No Intervention
  1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).
  2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age

Mesh

Experimental
  1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).
  2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
  3. Mesh product distributed to households

干预措施: Mesh - spatial repellent impregnated with transfluthrin (2500mg) (Combination Product)

Mesh

Experimental
  1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).
  2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
  3. Mesh product distributed to households

干预措施: Information and Education Campaigns (IEC) (Behavioral)

Mesh

Experimental
  1. Information and Education Campaigns (IEC) campaigns will formally encourage breeding site management through; good practice household-level water storage (covering and cleaning of water storage containers) and waste management (removal of potential breeding sites in and around the home).
  2. Epidemiological surveillance: test and treat malaria cases in children 6 - 10 years of age
  3. Mesh product distributed to households

干预措施: test and treat malaria cases (Diagnostic Test)

结局指标

主要结局

epidemiological outcome: malaria incidence

时间窗: 7 months

Malaria incidence will be estimated as the total number of malaria episodes per person over the course of the trial.

entomological outcome: vector density

时间窗: 7 months

the relative infestation rate of disease vectors (females of any of Anopheles malaria vectors, Aedes aegypti, or phlebotomine sand flies

次要结局

  • feasibility, acceptance and uptake of Mesh(7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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