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临床试验/NCT02362932
NCT02362932已完成不适用

A Controlled Before and After Study to Measure the Effect of an Urban Sanitation Intervention on Child Health, in Low-income Neighborhoods of Maputo, Mozambique

London School of Hygiene and Tropical Medicine2 个研究点 分布在 1 个国家目标入组 1,866 人开始时间: 2015年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,866
试验地点
2
主要终点
Combined prevalence of bacterial and protozoan enteric infections

研究概览

简要总结

The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.

详细描述

We have designed a controlled, before-and-after (CBA) effectiveness study to estimate the health impacts of an urban sanitation intervention in informal neighborhoods of Maputo, Mozambique, including an assessment of whether exposures and health outcomes vary by localized population density. The intervention consists of private pour-flush latrines (to septic tank) shared by multiple households in compounds or household clusters. We will measure objective health outcomes in approximately 1000 children (500 children with household access to interventions, 500 controls using existing shared private latrines in poor sanitary conditions), at two time points: immediately before the intervention and at follow-up after 12 months. The primary outcome is combined prevalence of enteric infections among children under 5 years of age. Secondary outcome measures include soil transmitted helminth (STH) re-infection in children following baseline de-worming and prevalence of reported gastrointestinal illness. We will use exposure assessment, fecal source tracking, and microbial transmission modeling to examine whether and how routes of exposure for diarrheagenic pathogens and STHs vary and transmission impacts of the pathogens following introduction of effective sanitation. Our analysis will focus specifically on the impact of localized population density as a potential modifier of sanitation-related exposures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
29 Days 至 48 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection criteria (including number of people served)

排除标准

  • Refusal to participate

研究组 & 干预措施

Control

No Intervention

No sanitation

Intervention

Experimental

Sanitation

干预措施: Sanitation (Other)

结局指标

主要结局

Combined prevalence of bacterial and protozoan enteric infections

时间窗: 12 month follow-up

As identified via molecular assays on stool samples, we will measure combined prevalence of the following enteric infections: Campylobacter; Clostridium difficile, Toxin A/B; E. coli O157; Enterotoxigenic E. coli (ETEC) LT/ST; Shiga-like toxin producing E. coli (STEC) stx1/stx2; Salmonella; Shigella; Vibrio cholerae; Yersinia enterocolitica; Giardia; Cryptosporidium; and Entamoeba histolytica

次要结局

  • Combined helminth re-infection at 1 year following baseline de-worming(24 month follow-up)
  • Period prevalence (7-day recall) of gastrointestinal illness(24 month follow-up)
  • Height-for-age z-score(24 month follow-up)
  • Combined prevalence of bacterial and protozoan enteric infections(24 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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