Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Part of paid clinical trials in Hazelwood, Missouri.
- Sponsor
- Washington University School of Medicine
- Study ID
- NCT04875520
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Screening testing strategy — OTHERThe intervention we are evaluating is the use of weekly screening testing among students and staff.
- No screening testing strategy — OTHERa group of schools will not receive screening testing.
Study Details
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.
Key Dates
- Start date
- May 7, 2021
- Status verified
- Jan 2026
- Primary completion
- May 31, 2023
- Completion
- Dec 31, 2023
Study Design
- Enrollment
- 1,390 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Weekly Screening testing plus symptomatic testingAmong 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.
- Active Comparator: Symptomatic testingAll 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
Primary Outcome Measure
Overall Rate of All COVID-19 Cases in Schools. [ Time Frame: Up to one year. ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ferguson-Florissant School District | Hazelwood | Missouri | 63042 | - |
| Jennings School District | Jennings | Missouri | 63136 | - |
| Pattonville School District | Saint Ann | Missouri | 63074 | - |
| Normandy Schools Collaborative | St Louis | Missouri | 63121 | - |
| The School District of University City | University City | Missouri | 63130 | - |
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