Rural Appalachia Pilot Water Treatment Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Water-Related Diseases, Enteric Pathogens, Exposure to Chemical Pollution

Intervention / Treatment
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* Device: Countertop pitcher water filter


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |