Rural Appalachia Pilot Water Treatment Trial

Water-Related Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120985
• Other study ID #: 23-685
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2023
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Danielle Short, MPH
• Phone: 540-231-3954
• Email: daniella09[@]vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

• The household does not have utility-supplied water at the time of enrollment,
• The household has at least one child aged three or younger 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).

Related Conditions & MeSH terms

• Enteric Pathogens
• Water-Related Diseases
• Waterborne Diseases

Intervention

Device:
• Countertop pitcher water filter
Point-of-use drinking water filter

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	E. coli detection in drinking water	Proportion of households with E. coli (indicator of fecal contamination) detected in drinking water samples	12 months
Primary	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	Gastrointestinal illness	Incidence of acute gastrointestinal illness via self-reported diarrhea (7-day recall)	12 months
Secondary	Pathogen infection	Detection of enteric pathogen infection via qPCR analysis of stool samples and salivary antibody assays	12 months