Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
- Conditions
- Covid19
- Interventions
- Other: Screening testing strategyOther: No screening testing strategy
- Registration Number
- NCT04875520
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2474
- A student or staff in one of the five school districts.
- Household members of a student or staff member in the five school districts.
- People not affiliated with the school.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Weekly Screening testing plus symptomatic testing Screening testing strategy 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. Symptomatic testing No screening testing strategy All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
- Primary Outcome Measures
Name Time Method School based transmission up to one year The average percentage of school-based contacts that test positive per case per school will be calculated
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Pattonville School District
๐บ๐ธSaint Ann, Missouri, United States
Jennings School District
๐บ๐ธJennings, Missouri, United States
Ferguson-Florissant School District
๐บ๐ธHazelwood, Missouri, United States
Normandy Schools Collaborative
๐บ๐ธSaint Louis, Missouri, United States
The School District of University City
๐บ๐ธUniversity City, Missouri, United States