Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- School based transmission [up to one year]
The average percentage of school-based contacts that test positive per case per school will be calculated
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ferguson-Florissant School District | Hazelwood | Missouri | United States | 63042 |
| 2 | Jennings School District | Jennings | Missouri | United States | 63136 |
| 3 | Pattonville School District | Saint Ann | Missouri | United States | 63074 |
| 4 | Normandy Schools Collaborative | Saint Louis | Missouri | United States | 63121 |
| 5 | The School District of University City | University City | Missouri | United States | 63130 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Jason G. Newland, MD, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- 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
- Centers for Disease Control and Prevention. Schools and Child Care Programs: Plan, Prepare, and Respond. 2021. Accessed March 11, 2021
Publications
- 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.
- 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.
- Falk A, Benda A, Falk P, Steffen S, Wallace Z, Høeg 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.
- Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88.
- 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. pii: 2020.05.07.20093542. doi: 10.1101/2020.05.07.20093542. Update in: Clin Chem. 2021 Jan 30;67(2):415-424.
- 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.
- 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.
- 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.
- 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). pii: e2020048090. doi: 10.1542/peds.2020-048090. Epub 2021 Jan 8.
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