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

Primary Purpose

Covid19

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening testing strategy
No screening testing strategy
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Covid19 focused on measuring SARS-CoV-2, Screening testing, School-based COVID-19 Transmission

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Ferguson-Florissant School District
  • Jennings School District
  • Pattonville School District
  • Normandy Schools Collaborative
  • The School District of University City

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Weekly Screening testing plus symptomatic testing

Symptomatic testing

Arm 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.

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

Outcomes

Primary Outcome Measures

School based transmission
The average percentage of school-based contacts that test positive per case per school will be calculated

Secondary Outcome Measures

Full Information

First Posted
April 29, 2021
Last Updated
July 24, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04875520
Brief Title
Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Official Title
Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
SARS-CoV-2, Screening testing, School-based COVID-19 Transmission

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekly Screening testing plus symptomatic testing
Arm Type
Active Comparator
Arm 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.
Arm Title
Symptomatic testing
Arm Type
Active Comparator
Arm Description
All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons.
Intervention Type
Other
Intervention Name(s)
Screening testing strategy
Intervention Description
The intervention we are evaluating is the use of weekly screening testing among students and staff.
Intervention Type
Other
Intervention Name(s)
No screening testing strategy
Intervention Description
a group of schools will not receive screening testing.
Primary Outcome Measure Information:
Title
School based transmission
Description
The average percentage of school-based contacts that test positive per case per school will be calculated
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason G. Newland, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferguson-Florissant School District
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Jennings School District
City
Jennings
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Pattonville School District
City
Saint Ann
State/Province
Missouri
ZIP/Postal Code
63074
Country
United States
Facility Name
Normandy Schools Collaborative
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63121
Country
United States
Facility Name
The School District of University City
City
University City
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33735165
Citation
Van Dyke ME, Mendoza MCB, Li W, Parker EM, Belay B, Davis EM, Quint JJ, Penman-Aguilar A, Clarke KEN. Racial and Ethnic Disparities in COVID-19 Incidence by Age, Sex, and Period Among Persons Aged <25 Years - 16 U.S. Jurisdictions, January 1-December 31, 2020. MMWR Morb Mortal Wkly Rep. 2021 Mar 19;70(11):382-388. doi: 10.15585/mmwr.mm7011e1.
Results Reference
background
PubMed Identifier
32551773
Citation
Bryant DJ, Oo M, Damian AJ. The rise of adverse childhood experiences during the COVID-19 pandemic. Psychol Trauma. 2020 Aug;12(S1):S193-S194. doi: 10.1037/tra0000711. Epub 2020 Jun 18.
Results Reference
background
PubMed Identifier
33230400
Citation
Benner AD, Mistry RS. Child Development During the COVID-19 Pandemic Through a Life Course Theory Lens. Child Dev Perspect. 2020 Dec;14(4):236-243. doi: 10.1111/cdep.12387. Epub 2020 Oct 15.
Results Reference
background
PubMed Identifier
33419869
Citation
Zimmerman KO, Akinboyo IC, Brookhart MA, Boutzoukas AE, McGann KA, Smith MJ, Maradiaga Panayotti G, Armstrong SC, Bristow H, Parker D, Zadrozny S, Weber DJ, Benjamin DK Jr; ABC SCIENCE COLLABORATIVE. Incidence and Secondary Transmission of SARS-CoV-2 Infections in Schools. Pediatrics. 2021 Apr;147(4):e2020048090. doi: 10.1542/peds.2020-048090. Epub 2021 Jan 8.
Results Reference
background
PubMed Identifier
33507890
Citation
Falk A, Benda A, Falk P, Steffen S, Wallace Z, Hoeg TB. COVID-19 Cases and Transmission in 17 K-12 Schools - Wood County, Wisconsin, August 31-November 29, 2020. MMWR Morb Mortal Wkly Rep. 2021 Jan 29;70(4):136-140. doi: 10.15585/mmwr.mm7004e3.
Results Reference
background
PubMed Identifier
32980377
Citation
Orscheln RC, Newland JG, Rosen DA. Practical School Algorithms for Symptomatic or SARS-CoV-2-Exposed Students Are Essential for Returning Children to In-Person Learning. J Pediatr. 2021 Feb;229:275-277. doi: 10.1016/j.jpeds.2020.09.060. Epub 2020 Sep 25. No abstract available.
Results Reference
background
PubMed Identifier
32213337
Citation
To KK, Tsang OT, Leung WS, Tam AR, Wu TC, Lung DC, Yip CC, Cai JP, Chan JM, Chik TS, Lau DP, Choi CY, Chen LL, Chan WM, Chan KH, Ip JD, Ng AC, Poon RW, Luo CT, Cheng VC, Chan JF, Hung IF, Chen Z, Chen H, Yuen KY. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 May;20(5):565-574. doi: 10.1016/S1473-3099(20)30196-1. Epub 2020 Mar 23.
Results Reference
background
PubMed Identifier
32511508
Citation
Lalli MA, Langmade SJ, Chen X, Fronick CC, Sawyer CS, Burcea LC, Wilkinson MN, Fulton RS, Heinz M, Buchser WJ, Head RD, Mitra RD, Milbrandt J. Rapid and extraction-free detection of SARS-CoV-2 from saliva with colorimetric LAMP. medRxiv. 2020 Aug 6:2020.05.07.20093542. doi: 10.1101/2020.05.07.20093542. Preprint.
Results Reference
background
PubMed Identifier
16204405
Citation
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
Results Reference
background
PubMed Identifier
35698094
Citation
Hayes S, Malone S, Bonty B, Mueller N, Reyes SM, Reyes SA, Evans C, Wilcher-Roberts M, Watterson T, Akuse S, Shelley J, Yuan G, Lackey I, Prater J, Montgomery B, Williams C, Butler-Barnes ST, Harris K, Caburnay C, Dougherty NL, Liu J, Lai A, Neidich J, Fritz S, Newland JG. Assessing COVID-19 testing strategies in K-12 schools in underserved populations: study protocol for a cluster-randomized trial. BMC Public Health. 2022 Jun 13;22(1):1177. doi: 10.1186/s12889-022-13577-z. Erratum In: BMC Public Health. 2022 Sep 1;22(1):1655.
Results Reference
derived
Links:
URL
http://www.propublica.org/article/early-data-shows-african-americans-have-contracted-and-died-of-coronavirus-at-an-alarming-rate
Description
Johnson A, Buford T. Early Data Shows African Americans Have Contracted and Died of Coronavirus at an Alarming Rate. Propublica. 2020. Accessed March 11, 2021
URL
https://www.educationnext.org/pandemic-parent-survey-finds-perverse-pattern-students-more-likely-to-be-attending-school-in-person-where-covid-is-spreading-more-rapidly
Description
Henderson MB, West MR, Peterson PE. Pandemic Parent Survey Finds Perverse Pattern: Students are More Likely to Be Attending School in Person Where COVID Is Spreading More Rapidly. Education Next. 2021;21(2). Accessed March 11, 2021
URL
https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare
Description
Centers for Disease Control and Prevention. Schools and Child Care Programs: Plan, Prepare, and Respond. 2021. Accessed March 11, 2021

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

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