WET: Wells and Enteric Disease Transmission

Sponsor

Temple University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04826991

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

908

Enrollment

Location

Arms

Anticipated Duration (Months)

20.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Approximately 40 million people in the US are served by private, and frequently untreated, wells. Our best estimate is that 1.3 million cases of gastrointestinal illnesses (GI) per year are attributed to consuming water from untreated private wells in the US, but in reality, there are no robust epidemiological data that can be used to estimate cases of GI attributable to these sources. We propose the first randomized controlled trial (RCT) to estimate the burden of GI associated with private well water. We will test if household treatment of private well water by ultraviolet light (UV) vs. sham (inactive UV device) decreases the incidence of GI in children under 5. We will also examine the presence of viral, bacterial, and protozoan pathogens in stool and well water from participants. These data will fill a knowledge gap on sporadic GI associated with federally-unregulated private water supplies in the US.

Condition or Disease	Intervention/Treatment	Phase
Diarrhea Gastrointestinal Infection Respiratory Viral Infection Waterborne Diseases	Device: Active UV Device Device: Inactive UV Device	N/A

Detailed Description

Investigators will conduct a triple-blinded randomized controlled trial of a whole-home UV water treatment device in southeastern Pennsylvania. Participating families will be randomized to receive an active UV device or a sham (inactive) UV device. Following the installation of the device, participants will be followed for one year. During that year, participants will respond to weekly text messages to report the presence of symptoms associated with gastrointestinal and respiratory illness in their children. Upon reporting symptoms, participants will complete an illness questionnaire on details regarding the illness and other potential exposure events. A subset of participants will submit groundwater samples as well as stool and saliva samples from their children. Water and stool samples will be analyzed for common waterborne pathogens. Saliva samples will be analyzed for immunoconversions to common waterborne pathogens (exploratory aim).

Under the guidance of an interdisciplinary advisory committee we will execute the following aims:

Aim 1- Quantify the incidence rate of endemic childhood GI associated with consuming untreated private well water and compare that to the incidence rate of consuming well water treated by UV.

Aim 1a- Construct a Quantitative Microbial Risk Assessment (QMRA) using water quality data we collect to estimate the risk of childhood GI associated with consuming untreated private well water and compare the incidence from the risk model to the incidence we calculate in Aim 1.

Aim 2- Identify, quantify and compare viral, bacterial and protozoan pathogens in stool of children consuming UV treated or untreated (sham) private well water (including both asymptomatic and symptomatic cases).

Aim 3- Explore the presence of pathogens in untreated well water and stool samples of children consuming untreated private well water (sham group only).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

908 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.A whole-home UV water treatment system will be installed and operated at a minimum of 50 millijoules per square centimeter.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants, device installers, investigators, and outcomes assessor will all be blinded.

Primary Purpose:

Prevention

Official Title:

Wells and Enteric Disease Transmission - A Randomized Trial of Children Supplied Drinking Water From Private Wells (WET-Trial)

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

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 UV Device Active water treatment system
Sham Comparator: Inactive UV Device A household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device).	Device: Inactive UV Device Inactive water treatment system

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 UV Device

Active water treatment system

Sham Comparator: Inactive UV Device

A household water treatment device with a lamp not emitting germicidal UV but still emitting light (appears identical to the active UV device).

Device: Inactive UV Device

Inactive water treatment system

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 (type, incidence, severity, duration, etc.), 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.

Secondary Outcome Measures

Acute respiratory infection [12 months]
The investigators will collect data on the presence of acute respiratory infection symptoms through weekly text messages. Households that report symptoms through text messages will be directed to an online illness questionnaire to characterize the symptoms (type, incidence, severity, duration, etc.) as well as relevant exposure information such as recent travel, exposure to ill persons, etc. Acute respiratory infection is defined by the reporting of nasal congestion/discharge, sore throat or mouth sores, or cough lasting at least one day, in the absence of another explanation, such as isolated cough without nasal symptoms in known reactive airways disease. 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
Parent/guardian has access to a phone with texting capabilities