COVID-19 Surveillance and Exposure Testing in School Communities

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Durham Charter Schools, Durham, North Carolina, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).

Exclusion criteria

None

Treatment and study plan

Primary outcomes

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

Time frame: 2 years

Proportion of students/staff with positive SARS-CoV-2 test identified by surveillance testing.
Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.

Time frame: 2 years

Proportion of students/staff with positive SARS-CoV-2 test following within-school exposure.
Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.

Time frame: 2 years

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

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Apr 5, 2021
Registry last updated: Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed