COVID-19 Surveillance and Exposure Testing in School Communities

NCT04831866 | Completed

• 1 other identifier: Pro00108049
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices. Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff. Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

Conditions

Covid19

Outcome Measures

Primary Outcomes (4)

• Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.

  Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.

  2 years

• Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.

  Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.

  2 years

• Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.

  Proportion of students who return to in-person education in Fall 2021, Spring 2022, and Fall 2022 from participating schools conducting surveillance testing compared to districts without testing.

  2 years

• Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.

  Mean time to return-to-school after SARS-CoV-2 exposure in the month after initiation of the school-provided testing program compared to the month prior to initiation of the school-provided testing program.

  2 years

Study Arms (2)

Surveillance Cohort

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All students and staff who are members of participating school communities will be given the opportunity to consent to this study. Both children and adult school community members will be included in this study.

You may not qualify if:

• None

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Durham Charter Schools

Durham, North Carolina, 27710, United States

Location

Iredell-Statesville Schools

Statesville, North Carolina, 28677, United States

Location

Related Publications (1)

• Kalu IC, Zimmerman KO, Goldman JL, Keener Mast D, Blakemore AM, Moorthy G, Boutzoukas AE, Campbell MM, Uthappa D, DeLaRosa J, Potts JM, Edwards LJ, Selvarangan R, Benjamin DK, Mann TK, Schuster JE. SARS-CoV-2 Screening Testing Programs for Safe In-person Learning in K-12 Schools. J Pediatric Infect Dis Soc. 2023 Feb 27;12(2):64-72. doi: 10.1093/jpids/piac119.

  PMID: 36412278 DERIVED

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

Study Officials

• Kanecia Zimmerman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: April 26, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)