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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Symptomatic testing | Active Comparator | All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening testing strategy | Other | The intervention we are evaluating is the use of weekly screening testing among students and staff. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason G. Newland, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferguson-Florissant School District | Hazelwood | Missouri | 63042 | United States | ||
| Jennings School District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33735165 | Background | 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. | |
| 32551773 |
| Label | URL |
|---|---|
| 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 | View source |
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1390 individuals from 16 middle and high schools were enrolled.
All students, staff, and family members from 16 middle and high schools were eligible to participate.
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff. |
| FG001 | Symptomatic Testing | All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons. No screening testing strategy: a group of schools will not receive screening testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The unit analyzed were the number of the tests completed overall during the study. | Posted | Count of Units | Completed tests | Up to one year. | Completed tests | Completed tests |
|
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Deaths, serious adverse events, and non-serious adverse events were not assessed for study participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Screening testing strategy: The intervention we are evaluating is the use of weekly screening testing among students and staff. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason G. Newland, MD | Nationwide Children's Hospital | 614-722-3416 | Jason.Newland@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2023 | Dec 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2023 | Jun 10, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| No screening testing strategy | Other | a group of schools will not receive screening testing. |
|
| Jennings |
| Missouri |
| 63136 |
| United States |
| Pattonville School District | Saint Ann | Missouri | 63074 | United States |
| Normandy Schools Collaborative | St Louis | Missouri | 63121 | United States |
| The School District of University City | University City | Missouri | 63130 | United States |
| 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. |
| 33230400 | 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. |
| 33419869 | 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. |
| 33507890 | 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. |
| 32980377 | 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. |
| 32213337 | 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. |
| 32511508 | 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. |
| 16204405 | Background | Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687. |
| 42102300 | Derived | Walsh T, Hayes S, Liu J, Malone S, Fritz S, Xu Y, Bonty B, Butler-Barnes S, Evans C, Harris K, Montgomery B, Mueller N, Reyes SM, Reyes SA, Vestal L, Wilcher-Roberts M, Williams C, Newland JG. Assessing COVID-19 Testing Strategies in K-12 Schools in Underserved Populations. J Public Health Manag Pract. 2026 Jul-Aug 01;32(4):572-583. doi: 10.1097/PHH.0000000000002346. Epub 2026 May 7. |
| 35698094 | Derived | 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. |
| 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 | View source |
| BG001 | Symptomatic Testing | All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons. No screening testing strategy: a group of schools will not receive screening testing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participant Type | Missing data | Count of Participants | Participants |
|
| Received COVID-19 Vaccine | Other = prefer not to answer and unknown. | Count of Participants | Participants |
|
| Social Vulnerability Index | Missing data | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Completed tests |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Symptomatic Testing | All 16 schools will have testing available for individuals that have symptoms or need a test for other reasons. No screening testing strategy: a group of schools will not receive screening testing. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Other |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Household |
|
| Other |
|
| Medium - High |
|
| High |
|