NCT07818902

Brief Summary

The goal of this intervention trial is to learn if the use of drinking water filters will result in improved health outcomes for people living in homes with well water and spring water in rural regions of Central Appalachia.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,584

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026May 2030

Study Start

First participant enrolled

September 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

3.5 years

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

Acute Gastrointestinal IllnessCentral AppalachiaCluster Randomized Controlled TrialDiarrheaDrinking Water ContaminationEnteric PathogensIntervention TrialPoint-of-Use Water TreatmentRural HealthSpring WaterWater FiltrationWaterborne DiseasesWell Water

Outcome Measures

Primary Outcomes (1)

  • Acute gastrointestinal illness incidence

    Incidence of household-level acute gastrointestinal illness (AGI), based on individual-level reported 7-day AGI. AGI case definition: reported diarrhea today and/or any day in the last seven days. Individual-level reported fever, nausea, cramps, and vomiting data will also be collected. For those with reported AGI, investigators will also ask if they had three or more loose stools in a 24-hour period.

    12 months

Secondary Outcomes (2)

  • Waterborne pathogen infections

    12 months

  • E. coli or pathogens in water samples

    12 months

Study Arms (2)

Point-of-use water filter

EXPERIMENTAL

Households randomized to the treatment group will receive water filters at the beginning of the study.

Device: Water filter

Control

NO INTERVENTION

Households randomized to the control group will receive water filters after follow-up data collection is completed.

Interventions

Point-of-use multi-stage dispenser water filter with a membrane microfilter and a combined activated carbon and ion exchange filter

Point-of-use water filter

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Home is located in a study county in southwest Virginia or northeast Tennessee
  • There is at least one adult (aged 18 or older) who regularly (\>6 months per year) resides in the household
  • Household does not have utility-supplied water (and \<33% of household members regularly drink bottled water)
  • Reported household income is \<80% of the county median income (based on US Department of Housing and Urban Development thresholds by household population)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DiarrheaGastrointestinal DiseasesWaterborne Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDigestive System DiseasesInfections

Study Officials

  • Alasdair Cohen, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelsey Lane Warmbrod, PhD

CONTACT

Bethesda O'Connell, DrPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

September 14, 2026

Record last verified: 2026-09