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Rural Water Filtration and Health Study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07818902
Acronym
RWELL
Enrollment
1584
Registered
2026-09-14
Start date
2026-09-01
Completion date
2030-05-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Enteric Pathogens, Gastrointestinal Disease, Waterborne Diseases

Keywords

Acute Gastrointestinal Illness, Central Appalachia, Cluster Randomized Controlled Trial, Diarrhea, Drinking Water Contamination, Enteric Pathogens, Intervention Trial, Point-of-Use Water Treatment, Rural Health, Spring Water, Water Filtration, Waterborne Diseases, Well Water

Brief summary

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.

Detailed description

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.

Interventions

DEVICEWater filter

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

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER
East Tennessee State University
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
University of California, Berkeley
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Acute gastrointestinal illness incidence12 monthsIncidence 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

MeasureTime frameDescription
Waterborne pathogen infections12 monthsDetection 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.
E. coli or pathogens in water samples12 monthsDetection of E. coli in collected well and spring water samples or detection of enteric pathogens in filtered well and spring water samples.

Contacts

CONTACTKelsey Lane Warmbrod, PhD
wlane@vt.edu540-231-1816
CONTACTBethesda O'Connell, DrPH
oconnell@etsu.edu423-439-4816
PRINCIPAL_INVESTIGATORAlasdair Cohen, PhD

Virginia Polytechnic Institute and State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026