COVID-19 Surveillance and Exposure Testing in School Communities

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04831866
Collaborator
(none)
4,000
2
9.2
2000
217.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities
    Actual Study Start Date :
    Apr 26, 2021
    Actual Primary Completion Date :
    Jan 31, 2022
    Actual Study Completion Date :
    Jan 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

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

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

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

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

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Durham Charter Schools Durham North Carolina United States 27710
    2 Iredell-Statesville Schools Statesville North Carolina United States 28677

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Kanecia Zimmerman, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT04831866
    Other Study ID Numbers:
    • Pro00108049
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 13, 2022