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临床试验/NCT02372851
NCT02372851已完成不适用

Assessing the Effectiveness of a Point-of-use Water Filter Technology as an Arsenic Mitigation Strategy in West Bengal

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2015年1月1日最近更新:
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
362
试验地点
1
主要终点
Total urinary arsenic

研究概览

简要总结

The purpose of this study is to determine whether the use of a point-of-use water filtration technology can reduce the Arsenic content in drinking water and reduce the Arsenic body burden.

详细描述

The Unilever Pureit As+ filter will be assessed for chemical and microbiological performance and health impact using a parallel, household-randomised controlled trial (RCT) design over a four-month follow-up period.

This study will follow an open (non-blinded) design because filtration technologies are particularly challenging to blinding (Boisson et al., 2010). Equal randomisation will be applied (i.e. 1:1). Randomisation will be undertaken through a lottery organised in each participating village.

The study will be undertaken in two phases; an initial phase will involve a baseline survey in the identified affected communities. Those households identified as eligible during the baseline survey will then be randomised into the intervention or control group and the intervention will then be distributed. After a 2-4 week adaptation period, control and intervention arms will be followed at monthly visits for a period of four months.

The baseline study will collect information on demographics, sanitation facilities, hygiene practices, drinking water sources and treatment practices, diet of household members, knowledge of arsenic contamination and arsenicosis, and other factors that could potentially impact the outcomes of interest. Additionally, data on behavioural factors that have been observed to be associated with Household Water Treatment (HWT) use will be collected to predict intervention use in the intervention arm. During the baseline survey, water samples of source water and stored drinking water will be collected and tested for total thermotolerant coliforms (TTC) and total arsenic concentration. The female head of the household will be invited to provide a sample of urine for total urinary arsenic testing. The female head of the household will be followed because it is expected that she will be the household member that i. is mainly responsible for drinking water management, and ii. is at home most of the day and thus making it logistically feasible to obtain spot urine samples throughout the study.

At monthly intervals, participating households will be visited to assess filter use using self report as well as objective indicators. Additionally, in each round of follow-up, drinking water samples will be taken in all participating households for both microbiological and arsenic testing. Additionally, the female head of household will be invited to provide spot urine samples for total urinary arsenic at each round of follow up.

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Households will be eligible to participate in the study if (i) the water identified as drinking during the baseline survey has an arsenic concentration that exceeds 50 µg/L, when measured using a rapid portable field testing kit, (ii) an alternative arsenic mitigation project is not underway for the household at the time of enrolment, (iii) the household is within the designated geographical area of the study, (iv) the household lives permanently in the area and anticipates living in the area for the next 6 months, (v) the household is willing to participate and (vi) the female head of the household is at least 18 years, is able to provide consent (has no cognitive impairments) and accepts to provide urine samples.

排除标准

  • 未提供

研究组 & 干预措施

Pureit As+ Filter

Active Comparator

Each household will receive one water filter and a replacement battery for free during distribution. The intervention will be distributed door-to-door by the implementation team. Households will be trained on use and maintenance of the device according to the manufacturer's instructions. Households will be advised to drink exclusively from the water filter and to carry water with them if attending school or work. Households will also be advised to clean and cook their rice with filtered water only.

干预措施: Pureit As+ Filter (Device)

Control arm

No Intervention

The control arm will be advised to continue with their traditional drinking water and cooking practices. The control arm will receive the intervention at the end of the study period.

结局指标

主要结局

Total urinary arsenic

时间窗: 4 months

To assess the effectiveness of the Unilever Pureit As+ technology in decreasing the body burden of arsenic, measured in terms of total urinary arsenic

次要结局

  • Total arsenic removal in drinking water(4 months)
  • Total arsenic reduction in filtered water(4 months)
  • Mean TTC reduction in drinking water(4 months)
  • Self-reported use of the intervention(4 months)
  • Consistent use(4 months)
  • Prevalence of diarrhoea among <5s(4 months)
  • Prevalence of diarrhoea among all family members(4 months)
  • Bacterial removal(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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