Test to Stay in School: COVID-19 Testing Following Exposure in School Communities
Study Details
Study Description
Brief Summary
Participants in school communities who have been exposed to SARS-CoV-2 will be tested for COVID-19 on the day of exposure (day 1) and at days 3, 5, and 7 following initial known exposure. Mitigation practices including masking, the context of exposure (classroom, school bus, after school sporting event, lunch, etc.), and results of COVID-19 test will be documented.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a prospective, interventional study with a primary objective of evaluating severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission following exposure in Kindergarten through 12th grade schools. Participants will be tested with a COVID-19 testing kit that is Food and Drug Administration (FDA)-authorized under an emergency use authorization (EUA) for non-prescription use for both symptomatic and asymptomatic evaluation in children and adults. Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If a participant does not know of the exposure until more than one day following they exposure, they will be tested on the day they become aware of the exposure and then resume the aforementioned testing schedule (e.g. participant identifies exposure 3 days after the exposure, test on day 3, day 5, and day 7).
If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines. Demographic information, daily presence or absence of symptoms, whether the infected person or close contact was masked, setting of the exposure, test results, and school absences will be collected following consent. Data regarding school level mitigation practices will also be collected. Data collected from this study may be combined with school-provided data and publically available community data.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: COVID-19 Exposure Testing
|
Other: COVID-19 Testing
Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines.
|
Outcome Measures
Primary Outcome Measures
- Number of students with positive COVID-19 test following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test. [2 years]
- Number of staff with positive COVID-19 tests following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test. [2 years]
- Number of exposures (as measured by nurse report) undergoing the test-to-stay protocol that result in additional transmission, reported as a proportion (%) of the total number of participants enrolled in the study. [2 years]
- Time (in days) to test positivity (reported as a mean) among those exposed to SARS-CoV-2 and undergoing the test-to-stay protocol. [2 years]
Secondary Outcome Measures
- Number of masked students with positive test who were exposed from masked versus unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of masked staff with positive test who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of unmasked students with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of unmasked staff with positive tests who were exposed from masked compared to unmasked individuals, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of students with positive COVID-19 test after indoor vs. outdoor exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of students with positive COVID-19 test after athletic vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Number of students with positive COVID-19 test after bus vs. classroom exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a positive COVID-19 test. [2 years]
- Total number of school days missed due to symptoms after exposure, reported as a mean. [2 years]
- Total number of school days missed due to isolation after positive COVID-19 test, reported as a mean. [2 years]
- Total number of school days missed due to quarantine after SARS-CoV-2 exposure, reported as a mean. [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Consent completed
-
Child or adult that is part of a school community
-
Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school sporting event, etc.)
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Participating NC School Districts | Durham | North Carolina | United States | 27707 |
Sponsors and Collaborators
- Duke University
Investigators
- Principal Investigator: Kanecia Zimmerman, MD, MPH, Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00109436