Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population

The Washington University

Status: Completed

Conditions: Covid19

Treatments: Other: No screening testing strategy; Other: Screening testing strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04875520

202104013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,474 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,474 participants in 2 patient groups

Weekly Screening testing plus symptomatic testing

Active Comparator group

Description:

Among 16 middle and high schools, 8 will be randomized to offer students and staff weekly SARS-CoV-2 testing. Additionally, these schools will offer testing for symptomatic students, staff, household members in all age groups.

Treatment:

Other: Screening testing strategy

Symptomatic testing

Active Comparator group

Description:

All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.

Treatment:

Other: No screening testing strategy