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Rural Appalachia Pilot Water Treatment Trial

Expanding Safe Water Access to Improve Health Outcomes in Rural Appalachia: A Pilot Water Treatment Intervention Trial in Virginia & Tennessee

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06120985
Enrollment
76
Registered
2023-11-07
Start date
2023-11-19
Completion date
2025-11-08
Last updated
2026-09-10

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

Conditions

Enteric Pathogens, Exposure to Chemical Pollution, Water-Related Diseases

Brief summary

Consumption of unsafe drinking water is associated with a substantial burden of disease globally. In the USA, the burden of disease associated with consumption of contaminated drinking water from non-regulated private wells and springs in rural areas is relatively understudied and unclear. For some lower-income households in rural areas of the USA without access to reliably safe drinking water, point-of-use treatment with relatively low-cost pitcher filters could help to reduce exposures to contaminated water and associated adverse health outcomes. This pilot randomized controlled intervention trial will provide information and data on water quality and contamination exposures, associated health outcomes, and the adoption potential of point-of-use water filters in rural areas of Virginia and Tennessee.

Interventions

DEVICECountertop pitcher water filter

Point-of-use drinking water filter

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER
East Tennessee State University
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
Ballad Health
CollaboratorOTHER

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

* The household does not have utility-supplied water at the time of enrollment, * The household is considered to be "low-income" (based on federally defined income limits), * The household is in one of the selected study counties in TN or VA.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
E. coli detection in drinking water12 monthsProportion of households with E. coli (indicator of fecal contamination) detected in drinking water samples
Heavy metals or other contaminants exceeding EPA MCL12 monthsProportion of households with contaminants detected in drinking water at concentrations exceeding the US Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA) Maximum Contaminant Levels (MCL)

Secondary

MeasureTime frameDescription
Gastrointestinal illness12 monthsIncidence of acute gastrointestinal illness via self-reported diarrhea (7-day recall)
Pathogen infection12 monthsDetection of enteric pathogen infection via qPCR analysis of stool samples and salivary antibody assays

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlasdair Cohen, PhD

Virginia Polytechnic Institute and State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026