Evaluating Low-cost Automatic Water Disinfection Systems to Improve Water Quality and Child Health in Urban Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,549
- 试验地点
- 1
- 主要终点
- Diarrhea longitudinal prevalence
研究概览
简要总结
Municipal water networks within industrialized countries typically rely on centralized treatment to manage piped water quality. Optimal water quality at the tap, however, requires well-maintained piped distribution networks, and performs best when piped systems are fully pressurized. In low-income cities such as Dhaka, water distribution networks are inadequately maintained and typically supply intermittent service; as such, they are vulnerable to recontamination during negative pressure events. Among populations accessing these types of improved water sources in urban settings (e.g. shared taps), it is unknown if consistent treatment to provide chlorinated water at the point of collection would have a significant health benefit. Furthermore, almost all previous studies of water treatment interventions in low-income countries have been unblinded with self-reported diarrhea as the main outcome, casting doubt that reported impacts of water disinfection on diarrhea are not due entirely to social desirability bias. Stanford University in collaboration with icddr,b will conduct a randomized evaluation to assess the impact on access to automatically chlorinated water on water quality and child health.
详细描述
Investigators will conduct a blinded cluster randomized controlled trial to evaluate the health and economic impacts of having access to automatically chlorinated water. The unit of randomization will be shared water points that typically serve 20-200 households. Shared water points connected to holding tanks compatible with the water treatment technology, and serving more than 4 households with at least one child under five, will be identified. Households accessing eligible water points as their primary drinking water source will be enrolled before installation of chlorine devices, and a baseline survey will be conducted of water quality, diarrhea prevalence, and health care expenditures. Following this baseline, households will be randomly assigned to control or treatment groups. The chlorination devices will be installed at the treatment group water points, while a doser containing vitamin C (and no chlorine), will be installed in the control group. The free chlorine dosing target will be below <1ppm to preserve blinding. All households will be surveyed every 2-3 months for a total follow up period of 14-16 months (5-7 survey rounds, budget permitting).
Objectives:
- To evaluate the impact of an automated chlorination system on microbial stored drinking water quality, residual chlorine, user satisfaction, user perceptions of water taste and smell, under-five child diarrhea (longitudinal prevalence) compared to a control group.
- Compare the marginal additional cost (per person served) of installing and maintaining an automated chlorination system integrated with the current water supply infrastructure in low-income areas of Dhaka.
- Assess the impact of an automated chlorination system on hospital visits and health care expenditures.
- To measure secondary outcomes of the impact of an automated chlorination system including under-five child weight-for-age (WAZ), under-five height-for-age (HAZ), as well as levels of C-reactive protein and immunoglobin G in serum samples collected from children under five (these are objective indicators of infection, such as repeat diarrheal episodes).
Analysis:
The primary analyses will be intent-to-treat (investigators will analyze differences in outcomes between the treatment and control groups, with groups defined by their random allocation). Investigators will also conduct a secondary analysis comparing outcomes between intervention and control, where the intervention group is defined as those households that had free chlorine residual detected in their stored drinking water (treated on the treated analysis).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Households with at least one child under 60 months old
- •Households using enrolled shared water point as primary drinking water source
排除标准
- •Households with a private drinking water source
- •Note: New births and children under 60 months that migrate into compounds accessing the enrolled water points for drinking water will be enrolled into the study.
研究组 & 干预措施
Chlorination
Device: Water chlorination by the Flogenic Primary drinking water source will be outfitted with automatic dosing device supplied with chlorine tablets. The device is called the Flogenic.
干预措施: Water chlorination by the Flogenic (Device)
Control
Active control: Vitamin C dosing into water. Primary drinking water source will be outfitted with automatic dosing device supplied with vitamin C tablets. The device is not commercially available.
干预措施: Active control, vitamin C dosing into water (Device)
结局指标
主要结局
Diarrhea longitudinal prevalence
时间窗: Measured every 2-3 months for 16 months post baseline
1-week recall period, case definition is 3 or more loose/watery bowel movements in 24 hours
次要结局
- Height-for-age-z-score(Measured at baseline and 16 months after baseline)
- Weight-for-age-z-score(Measured every 2-3 months for 16 months post baseline)
- Respiratory illness longitudinal prevalence(Measured every 2-3 months for 16 months post baseline)
- Prevalence and number of enteric pathogens(Measured 6-12 months after intervention delivery among children under five)
- Caregiver defined diarrhea(Measured every 2-3 months for 16 months post baseline)
- C-reactive protein(Measured at baseline and conclusion of study (16 months post baseline) among children under five)
- total immunoglobin G (IgG)(Measured at baseline and conclusion of study (16 months post baseline) among children under five)
研究者
Stephen P Luby
Professor of Medicine
Stanford University