School Inner City Air Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-15

Study Completion Date

2030-08-31

Brief Summary

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The goal of this randomized clinical trial is to test the efficacy of high efficiency particulate air (HEPA) cleaners in reducing respiratory viral exposure and infections in elementary school classrooms. Classrooms will be randomized to active vs. sham HEPA cleaners. The main questions it aims to answer are:

* Do classroom HEPA cleaners reduce exposure to viruses?
* Do classroom HEPA cleaners reduce student and teacher infections?
* Do classroom HEPA cleaners reduce infections in family members?

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Detailed Description

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Classrooms from participating schools will be randomized to active vs. sham HEPA cleaners. From enrolled classrooms, we will enroll students, teachers, and members of the household. We will collect the following:

* longitudinal classroom air samples
* longitudinal upper respiratory samples
* longitudinal symptom surveys using the Wisconsin Upper Respiratory Symptom Survey (WURSS) Viral testing on collected air and respiratory samples will be performed using digital polymerase chain reaction (dPCR).

Conditions

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Viral Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Sham cleaners are constructed by removing the filters from air cleaners and adding a sound generator rendering them indistinguishable from active HEPA cleaners.

Study Groups

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Active HEPA cleaner

Active HEPA cleaners will be placed in classrooms throughout the school year

Group Type EXPERIMENTAL

Active classroom HEPA cleaner

Intervention Type OTHER

Commercially available portable HEPA cleaner

Sham HEPA cleaner

Sham HEPA cleaners will be placed in classrooms throughout the school year

Group Type PLACEBO_COMPARATOR

Sham classroom HEPA cleaner

Intervention Type OTHER

Commercially available portable HEPA cleaner with filtration device removed

Interventions

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Active classroom HEPA cleaner

Commercially available portable HEPA cleaner

Intervention Type OTHER

Sham classroom HEPA cleaner

Commercially available portable HEPA cleaner with filtration device removed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Children

* Grades K-5 (age 6-12 years)
* Attend one of the schools that the study team has permission to obtain classroom/school environmental samples
* Have no plans to move schools within the upcoming 12 months
* Subject and/or parent guardian must be able to understand and provide informed consent and also willing to participate in the study

Adults

* Adult (age 21 or older) parent, caretaker, or household member of child participating in this study, or teacher in classroom participating in study
* Able to understand and provide informed consent

Exclusion Criteria

Children

* Contraindication to or inability to participate in home self-collection of nasal swab samples
* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Adults

* Contraindication to or inability to participate in home self-collection of nasal swab samples
* Severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
* Severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
* Families who do not speak English or Spanish well enough to complete the survey questions, as validated versions in other languages are not available for all of the measures

Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes