Determination of the Impact of Water and Health Education on Trachoma and Ocular C. Trachomatis in Niger
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 2
- 主要终点
- trachoma
研究概览
简要总结
There are no specific trials addressing the benefit of water provision and health education on prevalence of trachoma and infection with ocular Chlamydia trachomatis over time, despite considerable effort to provide water resources in trachoma endemic areas. Such information is sorely needed, to advance the Global Alliance agenda for the Elimination of Blinding Trachoma. This community-based clinical trial will randomize ten communities in Maradi Niger, half to receive delivery of water and health education services, and half for delivery of services at a later date. We hypothesize that the intervention communities will have lower rates of trachoma and C. trachomatis one and two years after delivery of services compared to communities without such services. This trial will provide, for the first time, solid evidence of the effect of such services on trachoma, as well as the added benefit following antibiotic provision by the Ministry of Health on sustaining reductions in trachoma and infection.
详细描述
Objectives
This study has the following objectives:
- To determine the effect on clinical trachoma in a cohort of children from baseline to one, two, and three years post-intervention with a village-based water and health education program.
- To determine the effect on ocular C. trachomatis infection in a cohort of children from baseline to one, two, and three years post-intervention with a village-based water and health education program.
- A secondary outcome is the measure of under five years mortality in intervention compared to control
Study Design:
Population: We are proposing to evaluate trachoma over time in a sample of children age 1-5 years at baseline in villages in Niger where World Vision is planning immediate water and health education services delivery, compared to a sample of children in villages where services will be implemented after two years.
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
入排标准
- 年龄范围
- 6 Months 至 65 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •villages size between 900-2100 residents as of 1995 census in Kornaka West district of Niger
- •village leadership approval of entry of village in the study
- •sentinel children ages 6 months to 5 years and five months
排除标准
- •village already has health education program for hygiene
- •village within 5 km of a well
- •child already has a sibling in the study population
结局指标
主要结局
trachoma
ocular C. trachomatis infection
次要结局
- under five years mortality
