Rural Appalachia Pilot Water Treatment Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Enteric Pathogens; Water-Related Diseases; Exposure to Chemical Pollution
• Intervention / Treatment: Device: Countertop pitcher water filter

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alasdair Cohen, PhD; Phone Number: 540-231-9010; Email: agcohen@vt.edu
• Study Contact Backup: Name: Bethesda O'Connell, PhD; Phone Number: 423-439-4816; Email: OCONNELL@mail.etsu.edu

Study Locations

• United States
  • Tennessee
    • Johnson City, Tennessee, United States, 37614
      • Recruiting
      • East Tennessee State University
      • Contact: Bethesda O'Connell, PhD; Phone Number: 423-439-4816; Email: OCONNELL@mail.etsu.edu
  • Virginia
    • Blacksburg, Virginia, United States, 24061
      • Recruiting
      • Virginia Tech
      • Contact: Alasdair Cohen, PhD; Phone Number: 540-231-9010; Email: agcohen@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: University of North Carolina, Chapel Hill; East Tennessee State University; Ballad Health
• Investigators: Principal Investigator: Alasdair Cohen, PhD, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Waterborne Diseases
• Other Study ID Numbers: 23-685

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No