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Completed

NCT Number: NCT06120985

Rural Appalachia Pilot Water Treatment Trial

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.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Tennessee State University, Johnson City, Tennessee, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Countertop pitcher water filter

Device

Point-of-use drinking water filter

Primary outcomes

  1. E. coli detection in drinking water

    Time frame: 12 months

    Proportion of households with E. coli (indicator of fecal contamination) detected in drinking water samples

  2. Heavy metals or other contaminants exceeding EPA MCL

    Time frame: 12 months

    Proportion 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 outcomes

  1. Gastrointestinal illness

    Time frame: 12 months

    Incidence of acute gastrointestinal illness via self-reported diarrhea (7-day recall)

  2. Pathogen infection

    Time frame: 12 months

    Detection of enteric pathogen infection via qPCR analysis of stool samples and salivary antibody assays

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Ballad Health
  • East Tennessee State University
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2023
Registry last updated
Jan 16, 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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