Clinical trial NCT04875520: Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Official title: Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: SARS-CoV-2
Screening testing
School-based COVID-19 Transmission
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 2474
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this study is to determine the most effective SARS-CoV-2 testing strategy for successful return of in-person school in the under-served communities of St. Louis.

Regular screening testing has been recommended by the CDC as an additive mitigation strategy for in-person schools in areas of high community transmission. We will compare the effectiveness and acceptance of two different school-based testing strategies among students and school staff (symptomatic testing only versus weekly surveillance testing plus symptomatic testing), measuring school-based SARS-CoV-2 transmission through a cluster randomized trial.

Detailed description: We will complete a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly screening testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 16 middle and high schools from five school districts in the St. Louis metropolitan area will be cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. The symptomatic testing will be provided to the entire school community as well as household members of students and staff.

The second Aim will evaluate existing mitigation strategies utilized in schools and the rate of school-based SARS-CoV-2 transmission by defining the mitigation strategies utilized in participating schools through survey tools developed with CDC and their impact on school-based COVID-19 transmission and quantifying the rate of COVID-19 transmission in schools and the impact of this transmission on households through extensive interviews and testing of contacts and household members.

Our 3rd Aim involves partnering with community-based organizations to specify and address the social, ethical, and behavioral implications of in-person schooling during the COVID-19 pandemic and the impact of SARS-CoV-2 testing on the school and community. Listening sessions will be utilized to understand barriers and facilitators to testing, ethical concerns of the community in research participation, and the behavioral health impact of lack of in-person schooling.

Eligibility criteria: Inclusion Criteria:

* A student or staff in one of the five school districts.
* Household members of a student or staff member in the five school districts.

Exclusion Criteria:

* People not affiliated with the school.

Primary outcomes:
measure: School based transmission
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hazelwood
country: United States
facility: Ferguson-Florissant School District
state: Missouri
city: Jennings
country: United States
facility: Jennings School District
state: Missouri
city: Saint Ann
country: United States
facility: Pattonville School District
state: Missouri
city: Saint Louis
country: United States
facility: Normandy Schools Collaborative
state: Missouri
city: University City
country: United States
facility: The School District of University City
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jason G. Newland, MD
role: PRINCIPAL_INVESTIGATOR
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