Rural Appalachia Pilot Water Treatment Trial

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06120985

Collaborator

East Tennessee State University (Other), University of North Carolina, Chapel Hill (Other), Ballad Health (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Water-Related Diseases Enteric Pathogens Exposure to Chemical Pollution	Device: Countertop pitcher water filter	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment Households randomized to the treatment group will be provided countertop pitcher water filters	Device: Countertop pitcher water filter Point-of-use drinking water filter
No Intervention: Control Households randomized to the control group will be provided water filters at the completion of the study

Arm

Intervention/Treatment

Active Comparator: Treatment

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

Device: Countertop pitcher water filter

Point-of-use drinking water filter

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Household is eligible for, or already part of, Ballad Health's Strong Starts program,
The household does not have utility-supplied water at the time of enrollment,
The household has at least one child aged two or younger at the time of enrollment,
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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Tennessee State University	Johnson City	Tennessee	United States	37614
2	Virginia Tech	Blacksburg	Virginia	United States	24061

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alasdair Cohen, PhD, Virginia Polytechnic Institute and State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alasdair Cohen, Assistant Professor of Environmental Epidemiology, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT06120985

Other Study ID Numbers:

23-685

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Waterborne Diseases

Study Results

No Results Posted as of Nov 9, 2023