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

NCT04875520 | Completed Results DMC

• 1 other identifier: 202104013
• Study Type: interventional
• Target: 1,390
• Locations: 1 country
• Sites: 5

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.

Conditions

Covid19

Keywords

SARS-CoV-2; Screening testing; School-based COVID-19 Transmission

Outcome Measures

Primary Outcomes (1)

• Overall Rate of All COVID-19 Cases in Schools.

  The rate of all new COVID-19 cases of student/staff in schools per randomization group.

  Up to one year.

Study Arms (2)

Weekly Screening testing plus symptomatic testing

ACTIVE COMPARATOR

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

Symptomatic testing

ACTIVE COMPARATOR

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

Other: No screening testing strategy

Interventions

Screening testing strategy OTHER

The intervention we are evaluating is the use of weekly screening testing among students and staff.

Weekly Screening testing plus symptomatic testing

No screening testing strategy OTHER

a group of schools will not receive screening testing.

Symptomatic testing

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A student or staff in one of the five school districts.
• Household members of a student or staff member in the five school districts.

You may not qualify if:

• People not affiliated with the school.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (5)

Ferguson-Florissant School District

Hazelwood, Missouri, 63042, United States

Location

Jennings School District

Jennings, Missouri, 63136, United States

Location

Pattonville School District

Saint Ann, Missouri, 63074, United States

Location

Normandy Schools Collaborative

St Louis, Missouri, 63121, United States

Location

The School District of University City

University City, Missouri, 63130, United States

Location

Related Publications (10)

• 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.

  PMID: 33735165 BACKGROUND

• 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.

  PMID: 32551773 BACKGROUND

• 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.

  PMID: 33230400 BACKGROUND

• 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.

  PMID: 33419869 BACKGROUND

• 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.

  PMID: 33507890 BACKGROUND

• 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.

  PMID: 32980377 BACKGROUND

• 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.

  PMID: 32213337 BACKGROUND

• 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 [Preprint]. 2020 Aug 6:2020.05.07.20093542. doi: 10.1101/2020.05.07.20093542.

  PMID: 32511508 BACKGROUND

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• 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.

  PMID: 35698094 DERIVED

Related Links

• 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
• 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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Small sample size. Local and federal COVID-19 recommendations and precautions were continuously changing. The omicron surge in St. Louis presented an unforeseeable strain on the study's testing resources, and symptomatic testing had to be paused for 37 days. Due to the specific PCR test utilized not being designed for a high positivity rate. Study experienced lower recruitment than expected.

Results Point of Contact

• Title: Jason G. Newland, MD
• Organization: Nationwide Children's Hospital

Jason.Newland@nationwidechildrens.org

614-722-3416

Study Officials

• Jason G. Newland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 6, 2021
• Study Start: May 7, 2021
• Primary Completion: May 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 18, 2026
• Results First Posted: July 4, 2025

Record last verified: 2026-01

Locations

US (5)