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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04875520
Recruitment Status : Active, not recruiting
First Posted : May 6, 2021
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Jason Newland, Washington University School of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Covid19 Other: Screening testing strategy Other: No screening testing strategy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Actual Study Start Date : May 7, 2021
Actual Primary Completion Date : May 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Screening testing strategy
The intervention we are evaluating is the use of weekly screening testing among students and staff.
Active Comparator: Symptomatic testing
All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
 Other: No screening testing strategy
a group of schools will not receive screening testing.


Outcome Measures
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Primary Outcome Measures :
  1. School based transmission [ Time Frame: up to one year ]
    The average percentage of school-based contacts that test positive per case per school will be calculated


Eligibility Criteria
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Ages Eligible for Study:   0 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875520


Locations
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United States, Missouri
Ferguson-Florissant School District
Hazelwood, Missouri, United States, 63042
Jennings School District
Jennings, Missouri, United States, 63136
Pattonville School District
Saint Ann, Missouri, United States, 63074
Normandy Schools Collaborative
Saint Louis, Missouri, United States, 63121
The School District of University City
University City, Missouri, United States, 63130
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jason G. Newland, MD Washington University School of Medicine
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jason Newland, Professor Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04875520    
Other Study ID Numbers: 202104013
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jason Newland, Washington University School of Medicine:
SARS-CoV-2
Screening testing
School-based COVID-19 Transmission
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases