Rural Appalachia Pilot Water Treatment Trial

Not Applicable

Active, not recruiting

• Conditions: Exposure to Chemical Pollution; Water-Related Diseases; Enteric Pathogens
• Interventions: Device: Countertop pitcher water filter

• Registration Number: NCT06120985
• Lead Sponsor: Virginia Polytechnic Institute and State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Study First Posted: 2023-11-07
• Study Start: 2023-11-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-20
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Countertop pitcher water filter	Households randomized to the treatment group will be provided countertop pitcher water filters

Primary Outcome Measures

Name	Time	Method
E. coli detection in drinking water	12 months	Proportion of households with E. coli (indicator of fecal contamination) detected in drinking water samples
Heavy metals or other contaminants exceeding EPA MCL	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 Outcome Measures

Name	Time	Method
Pathogen infection	12 months	Detection of enteric pathogen infection via qPCR analysis of stool samples and salivary antibody assays
Gastrointestinal illness	12 months	Incidence of acute gastrointestinal illness via self-reported diarrhea (7-day recall)

Trial Locations

Locations (2)

East Tennessee State University; 🇺🇸 Johnson City,, Tennessee, United States

Virginia Tech; 🇺🇸 Blacksburg, Virginia, United States