Wells and Enteric Disease Transmission Trial (WET - Trial)

Study Overview
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Brief Summary
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Approximately 40 million people in the US are served by private wells, many of which are untreated. The investigators estimate that 1.29 million cases of gastrointestinal illness (GI) per year are attributed to consuming water from untreated private wells in the US. These cases of GI can cause a significant burden in terms of health care costs and lost work/school days, as well as increased risk to developing longer term health complications. This impact is magnified when accounting for vulnerable populations such as children under the age of 5, the elderly and the immunocompromised. The investigators are preparing to conduct the first household randomized controlled trial (RCT) to investigate whether consuming well water treated by ultraviolet light (UV) compared to consuming untreated private well water decreases the incidence of self-reported gastrointestinal illness and respiratory infections in children under 5. The investigators will collect illness symptom data using a combination of weekly text messages and online illness questionnaires.

Official Title
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Wells and Enteric Disease Transmission - A Randomized Controlled Trial (WET- Trial)

Conditions
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Gastrointestinal Infection, Respiratory Viral Infection

Intervention / Treatment
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* Device: Active household UV water treatment device
* Device: Inactive household UV water treatment device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child resides in Berks, Bucks, Chester, Lancaster, Lehigh, or Montgomery County in Pennsylvania Household is served by a private well Participant child is under the age of 5 (under 4 at time of enrollment), who is a full-time resident of the home and drinks untreated well water (75% or more of water consumption must be from untreated well water) Parent/guardian has access to a phone with texting capabilities Exclusion Criteria: Child participant is immunocompromised Child participant has a chronic gastrointestinal condition Child takes daily oral steroids Household treats water before consumption (with the exception of water softeners)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active UV Device<br>A household water treatment device with a lamp emitting germicidal UV. The device will be operated at 50 millijoule per square centimeter to treat >99.9% of all bacteria, protozoa, and most viruses in water supplies. | Device: Active household UV water treatment device<br>* This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.<br>|
| Sham Comparator: Inactive UV Device<br>A device that appears identical to the active comparator device except the lamp will not emit germicidal UV. | Device: Inactive household UV water treatment device<br>* This sham device will use a lamp not emitting germicidal UV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident gastrointestinal illness | The investigators will collect data on the presence of gastrointestinal illness symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (incidence, severity, duration, diarrhea, vomiting, coughing, etc.), febrile episodes, as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Incident gastrointestinal illness (GI) is defined by the reporting of a minimum of three episodes of diarrhea or vomiting in a 24 hour period. Each illness will be considered distinct when separated by ≥ 6 symptom-free days. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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groundwater, private wells, acute gastrointestinal illness, respiratory infection