School Inner City Air Study
- Conditions
- Viral Infection
- Interventions
- Other: Active classroom HEPA cleanerOther: Sham classroom HEPA cleaner
- Registration Number
- NCT05953233
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active HEPA cleaner Active classroom HEPA cleaner Active HEPA cleaners will be placed in classrooms throughout the school year Sham HEPA cleaner Sham classroom HEPA cleaner Sham HEPA cleaners will be placed in classrooms throughout the school year
- Primary Outcome Measures
Name Time Method Viral pathogen detected in upper respiratory sample 1 year Presence/absence of a respiratory virus in upper respiratory sample
- Secondary Outcome Measures
Name Time Method Severity of a cold in adult using the WURSS-24 1 year 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.
Number of missed school or work days in last 30 days 1 year 30 day recall of missed school or work days. Range 0 - 30; higher indicates more severe.
Symptomatic respiratory infection (household member) 1 year Presence/absence of a cold based on 30 day recall
Viral detection in classroom bioaerosol sample 1 year Viral detection in classroom bioaerosol sample (viral copy number per cubic meter of air)
Number of days requiring inpatient or outpatient care in last 30 days 1 year 30 day recall of healthcare utilization defined as number of days requiring outpatient or inpatient hospital care. Range 0 - 30; higher indicates more severe.
Symptomatic respiratory infection (student, teacher) 1 year Presence/absence of a cold based on 30 day recall
Severity of a cold in child using the WURSS-K - Kids Daily Symptom Report 1 year 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.