Covid19NCT04875520
Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
A study testing Screening testing strategy and No screening testing strategy in people with Covid19, run by Washington University School of Medicine at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Screening testing strategy and No screening testing strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,390 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A student or staff in one of the five school districts.
- Household members of a student or staff member in the five school districts.
Who cannot join
- People not affiliated with the school.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ferguson-Florissant School District
Hazelwood, Missouri, 63042
Jennings School District
Jennings, Missouri, 63136
Pattonville School District
Saint Ann, Missouri, 63074
Normandy Schools Collaborative
St Louis, Missouri, 63121
The School District of University City
University City, Missouri, 63130
About this study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Screening testing strategy, No screening testing strategy
- Keywords
- SARS-CoV-2, Screening testing, School-based COVID-19 Transmission
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening testing strategyOther
The intervention we are evaluating is the use of weekly screening testing among students and staff.
No screening testing strategyOther
a group of schools will not receive screening testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: No screening testing strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start7 May 2021
- Primary completion31 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason G. Newland, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875520
- Sponsor's protocol ID
- 202104013
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2021
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33735165Bryant 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.
PubMed 32551773Benner 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.
PubMed 33230400Zimmerman 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.
PubMed 33419869Falk 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.
PubMed 33507890Orscheln 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.
PubMed 32980377To 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.
PubMed 32213337Lalli 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.
PubMed 32511508Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PubMed 16204405Walsh 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.
PubMed 42102300Hayes 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.
PubMed 35698094
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Testing Strategies for Safe Return to K-12 Schools in an Underserved Population
- ClinicalTrials.gov ID
- NCT04875520
- Acronym / sponsor ID
- 202104013
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Screening testing, School-based COVID-19 Transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,390 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly Screening testing plus symptomatic testing | Active comparator | Other: Screening testing strategyAmong 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 | Other: No screening testing strategyAll 16 schools will have testing available for individuals that have symptoms or need a test for other reasons. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- A student or staff in one of the five school districts.
- Household members of a student or staff member in the five school districts.
Key exclusion criteria (1 listed)
- People not affiliated with the school.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening testing strategyThe intervention we are evaluating is the use of weekly screening testing among students and staff. | Other | Weekly Screening testing plus symptomatic testing |
| No screening testing strategya group of schools will not receive screening testing. | Other | Symptomatic testing |
Primary outcome
Overall Rate of All COVID-19 Cases in Schools.
Time frame: Up to one year.
The rate of all new COVID-19 cases of student/staff in schools per randomization group.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33735165Van 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.
- Background: PubMed 32551773Bryant 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.
- Background: PubMed 33230400Benner 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.
- Background: PubMed 33419869Zimmerman 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.
- Background: PubMed 33507890Falk 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.
- Background: PubMed 32980377Orscheln 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.
- Background: PubMed 32213337To 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.
- Background: PubMed 32511508Lalli 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.
- Background: PubMed 16204405Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
- Derived from this study: PubMed 42102300Walsh 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.
- Derived from this study: PubMed 35698094Hayes 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.
- Johnson A, Buford T. Early Data Shows African Americans Have Contracted and Died of Coronavirus at an Alarming Rate. Propublica. 2020. Accessed March 11, 2021Link provided by the sponsor.
- 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, 2021Link provided by the sponsor.
- Centers for Disease Control and Prevention. Schools and Child Care Programs: Plan, Prepare, and Respond. 2021. Accessed March 11, 2021Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason G. Newland, MD principal investigator
Washington University School of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening testing strategy and No screening testing strategy in people with Covid19, run by Washington University School of Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Rate of All COVID-19 Cases in Schools. (time frame: Up to one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875520, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.