Water-Related DiseasesNCT06120985
Rural Appalachia Pilot Water Treatment Trial
A study testing Countertop pitcher water filter in people with Water-Related Diseases and Enteric Pathogens, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Water-Related Diseases, Enteric Pathogens, Exposure to Chemical Pollution
- What is being tested?
- Countertop pitcher water filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2023to 8 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None (no exclusion criterion based on gender, race, ethnicity, language, or literacy).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Tech
Blacksburg, Virginia, 24061
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
Official title: 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.
- Being tested
- Countertop pitcher water filter
- Medical subject headings
- Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Countertop pitcher water filterDevice
Point-of-use drinking water filter
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Households randomized to the treatment group will be provided countertop pitcher water filters Receives: Device: Countertop pitcher water filter |
| Control | No intervention | Households randomized to the control group will be provided water filters at the completion of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
E. coli detection in drinking water
Proportion of households with E. coli (indicator of fecal contamination) detected in drinking water samples
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
Gastrointestinal illness
Incidence of acute gastrointestinal illness via self-reported diarrhea (7-day recall)
Measured: 12 months
Pathogen infection
Detection of enteric pathogen infection via qPCR analysis of stool samples and salivary antibody assays
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start19 Nov 2023
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water-Related DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- East Tennessee State University, University of North Carolina, Chapel Hill, Ballad Health
- Responsible party
- Principal investigator, Alasdair Cohen, Virginia Polytechnic Institute and State University
- Investigators
- Alasdair Cohen, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120985
- Sponsor's protocol ID
- 23-685
- Status last verified
- Jan 2026
- First submitted
- 1 Nov 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Safe Water Access to Improve Health Outcomes in Rural Appalachia: A Pilot Water Treatment Intervention Trial in Virginia & Tennessee
- ClinicalTrials.gov ID
- NCT06120985
- Acronym / sponsor ID
- 23-685
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- East Tennessee State University, University of North Carolina, Chapel Hill, Ballad Health
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Countertop pitcher water filterHouseholds randomized to the treatment group will be provided countertop pitcher water filters |
| Control | No intervention | –Households randomized to the control group will be provided water filters at the completion of the study |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None (no exclusion criterion based on gender, race, ethnicity, language, or literacy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Countertop pitcher water filterPoint-of-use drinking water filter | Device | Treatment |
Primary outcome
E. coli detection in drinking water
Time frame: 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
Time frame: 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)
2 secondary outcomes
Gastrointestinal illness
Time frame: 12 months
Pathogen infection
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alasdair Cohen, PhD principal investigator
Virginia Polytechnic Institute and State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Countertop pitcher water filter in people with Water-Related Diseases and Enteric Pathogens, run by Virginia Polytechnic Institute and State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E. coli detection in drinking water (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.