School Inner City Air Study

Study Overview
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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?

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).

Official Title
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School Inner City Air Study

Conditions
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Viral Infection

Intervention / Treatment
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* Other: Active classroom HEPA cleaner
* Other: Sham classroom HEPA cleaner


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 90 Years

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
Interventional Model Description: Classrooms will be randomized in a 1:1 ratio using a random number generator to active vs sham HEPA arms
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active HEPA cleaner<br>Active HEPA cleaners will be placed in classrooms throughout the school year | Other: Active classroom HEPA cleaner<br>* Commercially available portable HEPA cleaner<br>|
| Placebo Comparator: Sham HEPA cleaner<br>Sham HEPA cleaners will be placed in classrooms throughout the school year | Other: Sham classroom HEPA cleaner<br>* Commercially available portable HEPA cleaner with filtration device removed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral pathogen detected in upper respiratory sample | Presence/absence of a respiratory virus in upper respiratory sample | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic respiratory infection (student, teacher) | Presence/absence of a cold based on 30 day recall | 1 year | 
| Symptomatic respiratory infection (household member) | Presence/absence of a cold based on 30 day recall | 1 year | 
| Viral detection in classroom bioaerosol sample | Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air) | 1 year | 
| Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report | Severity of a cold (when present) in child will be graded using the Wisconsin Upper Respiratory Symptom Survey Kids Daily Symptom Report (WURSS-K). Range 0 - 42; higher indicates more severe. | 1 year | 
| Severity of a cold in adult using the WURSS-24 | Severity of a cold (when present) in adult will be graded using the Wisconsin Upper Respiratory Symptom Survey 24 Daily Symptom Report (WURSS-24). Range 0 - 161; higher indicates more severe. | 1 year | 
| Number of missed school or work days in last 30 days | 30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe. | 1 year | 
| Number of days requiring inpatient or outpatient care in last 30 days | 30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe. | 1 year |