跳至主要内容
临床试验/NCT07818902
NCT07818902尚未招募不适用

Expanding Safe Water Access to Improve Health Outcomes in Appalachia: The Rural Water Filtration and Health (RWELL) Trial

Virginia Polytechnic Institute and State University0 个研究点目标入组 1,584 人开始时间: 2026年9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
尚未招募
入组人数
1,584
主要终点
Acute gastrointestinal illness incidence

研究概览

简要总结

The goal of this intervention trial is to learn if the use of drinking water filters will result in improved health outcomes for people living in homes with well water and spring water in rural regions of Central Appalachia.

详细描述

Consumption of unsafe drinking water is associated with a substantial burden of disease. Tens of millions of people in the United States live in homes with unregulated private wells, primarily in rural regions. However, our understanding of drinking water contaminants and associated health impacts for individuals living in households with private water supply in rural areas of the United States is severely limited by a lack of data - particularly for individuals living in low-income households in rural areas of Appalachia, and in the Central Appalachia region especially.

The overarching goal of this study is to assess the potential of a household-level water treatment intervention for expanding safe water access and improving health outcomes and wellbeing for rural households without utility-supplied water. Investigators will enroll approximately 480 households (approximately 1,600 individuals) that use well water and spring water and conduct a cluster-randomized controlled trial in southwest Virginia and northeast Tennessee to evaluate the hypothesized benefits of point-of-use water filtration.

Investigators will undertake the following aims:

  1. Measure the effect of drinking water filtration on the incidence of reported acute gastrointestinal illness.
  2. Measure the effect of drinking water filtration on the presence and quantity of bacterial, protozoal, and viral pathogens detected in saliva and stool biospecimens.
  3. Quantify fecal indicator organisms, waterborne pathogens, and regulated chemical contaminants in drinking water samples.

This study was designed to rigorously assess the hypothesized benefits of a relatively low-cost and easy to use point-of-use water treatment approach that can also improve the taste of water, and is a less-costly alternative to bottled water. Findings from this study will also substantially improve our understanding of which waterborne and enteric pathogens infants, children, and adults living in households with private water supplies in rural areas of Central Appalachia are exposed to and infected with, enabling more informed estimates of the associated burden of disease for rural populations without utility-supplied water.

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 (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Home is located in a study county in southwest Virginia or northeast Tennessee
  • There is at least one adult (aged 18 or older) who regularly (>6 months per year) resides in the household
  • Household does not have utility-supplied water (and <33% of household members regularly drink bottled water)
  • Reported household income is <80% of the county median income (based on US Department of Housing and Urban Development thresholds by household population)

排除标准

  • None (no exclusion criterion based on gender, race, ethnicity, language, or literacy)

研究组 & 干预措施

Point-of-use water filter

Experimental

Households randomized to the treatment group will receive water filters at the beginning of the study.

干预措施: Water filter (Device)

Control

No Intervention

Households randomized to the control group will receive water filters after follow-up data collection is completed.

结局指标

主要结局

Acute gastrointestinal illness incidence

时间窗: 12 months

Incidence of household-level acute gastrointestinal illness (AGI), based on individual-level reported 7-day AGI. AGI case definition: reported diarrhea today and/or any day in the last seven days. Individual-level reported fever, nausea, cramps, and vomiting data will also be collected. For those with reported AGI, investigators will also ask if they had three or more loose stools in a 24-hour period.

次要结局

  • Waterborne pathogen infections(12 months)
  • E. coli or pathogens in water samples(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alasdair Cohen

Associate Professor

Virginia Polytechnic Institute and State University

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