Rural Appalachia Pilot Water Treatment Trial

NCT06120985 | Completed

• 1 other identifier: 23-685
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• E. coli detection in drinking water

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

  12 months

• Heavy metals or other contaminants exceeding EPA MCL

  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)

  12 months

Secondary Outcomes (2)

• Gastrointestinal illness

  12 months

• Pathogen infection

  12 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Households randomized to the treatment group will be provided countertop pitcher water filters

Device: Countertop pitcher water filter

Control

NO INTERVENTION

Households randomized to the control group will be provided water filters at the completion of the study

Interventions

Countertop pitcher water filter DEVICE

Point-of-use drinking water filter

Treatment

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• East Tennessee State University: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Ballad Health: collaborator

Study Sites (2)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Waterborne Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Alasdair Cohen, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Environmental Epidemiology

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: November 19, 2023
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (2)