Enhancing Protection Against Vector-borne Diseases in Forcibly Displaced Communities: Evaluating the Efficacy of Spatial Repellents for Cutaneous Leishmaniasis Control in North-East Syria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 18,404
- 试验地点
- 1
- 主要终点
- Entomological outcome: phlebotomine sandfly density
研究概览
简要总结
The aim of this study is to determine the efficacy of Mosquito Shield (spatial repellent) in reducing cutaneous leishmaniasis case incidence among internally displaced persons and sandfly density in temporary shelters and camp settings in Ar-Raqqa governorate, North-East Syria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Known history of cutaneous leishmaniasis in camp Sleeping under same shelter type (all UNHCR tents / plastic sheets) Camp easily accessible by road Camps a minimum of 5km apart Adequate security levels
排除标准
- •Camps closer than 5km from a camp included in the study Camps with no previously recorded cases of cutaneous leishmaniasis Displaced communities living outside of defined camp settings
结局指标
主要结局
Entomological outcome: phlebotomine sandfly density
时间窗: 9 months
Phlebotomine sandfly density will be estimated monthly using Centers for Disease Control and Prevention light traps inside shelters.
Epidemiological outcome: cutaneous leishmaniasis incidence
时间窗: 11 or 9 months
Cutaneous leishmaniasis incidence per 1,000 will be estimated as the total number of cutaneous leishmaniasis episodes per 1,000 persons over the course of the trial. Two different incubation times or diagnostic cut-offs will be used: at 2 months post-intervention (from August 2021 to April 2022) and at 4 months post-intervention (from August 2021 to April 2022).
次要结局
- Intervention feasibility, acceptability and uptake(11 months)
研究者
Richard Allan
Principal Investigator
The Mentor Initiative