Wells and Enteric Disease Transmission Trial (WET - Trial)

Sponsor

Temple University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04258059

Collaborator

Pennsylvania Department of Health (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Infection Respiratory Viral Infection	Device: Active household UV water treatment device Device: Inactive household UV water treatment device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 30, 2020

Actual Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active UV Device 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 This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.
Sham Comparator: Inactive UV Device 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 This sham device will use a lamp not emitting germicidal UV.

Arm

Intervention/Treatment

Active Comparator: Active UV Device

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

This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.

Sham Comparator: Inactive UV Device

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

This sham device will use a lamp not emitting germicidal UV.

Outcome Measures

Primary Outcome Measures

Incident gastrointestinal illness [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)