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NCT Number: NCT07818902

Rural Water Filtration and Health Study

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.

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Key information

About this study

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:

  • Measure the effect of drinking water filtration on the incidence of reported acute gastrointestinal illness.
  • Measure the effect of drinking water filtration on the presence and quantity of bacterial, protozoal, and viral pathogens detected in saliva and stool biospecimens.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Water filter

Device

Point-of-use multi-stage dispenser water filter with a membrane microfilter and a combined activated carbon and ion exchange filter

Primary outcomes

  1. Acute gastrointestinal illness incidence

    Time frame: 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.

Secondary outcomes

  1. Waterborne pathogen infections

    Time frame: 12 months

    Detection of one or more pathogens that are either exclusively waterborne or highly likely to be waterborne via analysis of saliva and stool samples for bacterial, protozoal, and viral targets.

  2. E. coli or pathogens in water samples

    Time frame: 12 months

    Detection of E. coli in collected well and spring water samples or detection of enteric pathogens in filtered well and spring water samples.

Study contacts

Contact information is provided by the study sponsor or research team.

Bethesda O'Connell, DrPH

CONTACT

[email protected]

423-439-4816

Kelsey Lane Warmbrod, PhD

CONTACT

[email protected]

540-231-1816

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • East Tennessee State University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of California, Berkeley
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: RWELL

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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