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 — OTHER
    The intervention we are evaluating is the use of weekly screening testing among students and staff.
  • No screening testing strategy — OTHER
    a 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 testing
    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.
  • Active Comparator: Symptomatic testing
    All 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)

FacilityCityStateZIPSite coordinators
Ferguson-Florissant School DistrictHazelwoodMissouri63042-
Jennings School DistrictJenningsMissouri63136-
Pattonville School DistrictSaint AnnMissouri63074-
Normandy Schools CollaborativeSt LouisMissouri63121-
The School District of University CityUniversity CityMissouri63130-

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