Communities Fighting COVID Return to School

January 16, 2025 updated by: Susan M Kiene, San Diego State University

Communities Fighting COVID!: Returning Our Kids Back to School Safely

San Diego State University (SDSU), a designated Hispanic-serving institution, is partnering with Sweetwater Union High School District, an independent public school district serving 90% ethnic minority and a high proportion of socioeconomically disadvantaged students, and other community partners, to generate evidence for effective and feasible COVID-19 testing for unvaccinated and medically vulnerable middle school students and staff as part of broader COVID mitigation strategies including vaccination to return students back to school safely.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Equitable access to coronavirus 2019 (COVID-19) screening is important to reduce transmission and maintain in-person learning for middle school communities, particularly in disadvantaged schools. Rapid antigen testing, and at-home testing in particular, could offer substantial advantages over onsite testing from a school district's perspective, but it is unknown if engagement in at-home testing can be initiated and sustained. The investigators hypothesized that an at-home COVID-19 school testing program would be non-inferior to an onsite school COVID-19 testing program with regard to school participation rates and adherence to a weekly screening testing schedule. The study enrolled 3 middle schools within a large, predominantly Latinx-serving, independent school district into a noninferiority trial from October 2021 to March 2022. Two schools were randomized to onsite and 1 school to at-home COVID-19 testing programs. All students and staff were eligible to participate.

Study Type

Interventional

Enrollment (Actual)

852

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Sweetwater Union High School District

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School

Exclusion Criteria:

  • <2 years of age
  • Not a student or staff at a participating Sweetwater Union High School District Middle School

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: At-home testing
At-home COVID-19 testing model
Behavioral: At-home COVID-19 testing
At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
Active Comparator: On-site testing
On-site COVID-19 testing model
Behavioral: Onsite COVID-19 testing
Onsite COVID-19 testing for middle school students and staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to the Weekly COVID-19 Testing Schedule
Time Frame: through study completion, up to 21 weeks
Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial
through study completion, up to 21 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Diego State University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2021

Primary Completion (Actual)

April 2, 2022

Study Completion (Actual)

April 2, 2022

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 7, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HS-2021-0208
  • 1OT2HD108112-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared with the NIH RADx-UP Coordination and Data Collection Center (CDCC). The CDCC is charged by the NIH with making data funded by the RADx-UP initiative available to other researchers. Data are available on the NIH COVID RADx® Data Hub.

IPD Sharing Time Frame

Data are available when released by NIH COVID RADx® Data Hub after study completion. Data are available as long as maintained within the Data Hub.

IPD Sharing Access Criteria

Researchers can request access to the study data in the Data Hub via dbGaP, where they follow the prompts to request access. Once access is granted, the Researcher will be notified by email. If the Researcher is granted access to a specific study file, they will also have access to all the Data and Metadata files attached to the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Study Data/Documents

  1. COVID Rapid Acceleration of Diagnostics (RADx) Data Hub
    Information comments: Data from this study is available on the RADx Data Hub

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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