Communities Fighting COVID Return to School
Communities Fighting COVID!: Returning Our Kids Back to School Safely
2 other identifiers
interventional
852
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 17, 2021
CompletedFirst Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2022
CompletedResults Posted
Study results publicly available
January 17, 2025
CompletedJanuary 17, 2025
January 1, 2025
6 months
December 3, 2021
August 9, 2024
January 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adherence to the Weekly COVID-19 Testing Schedule
Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial
through study completion, up to 21 weeks
Study Arms (2)
At-home testing
EXPERIMENTALAt-home COVID-19 testing model
On-site testing
ACTIVE COMPARATOROn-site COVID-19 testing model
Interventions
At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
Onsite COVID-19 testing for middle school students and staff
Eligibility Criteria
You may qualify if:
- student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School
You may not qualify if:
- \<2 years of age
- Not a student or staff at a participating Sweetwater Union High School District Middle School
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sweetwater Union High School District
Chula Vista, California, 91911, United States
Related Publications (2)
McDaniels-Davidson C, Arechiga-Romero M, Snyder T, Chris N, Sturgis K, Moore V, Bravo R, Famania-Martinez L, Oren E, Kiene SM. Development of an At-Home COVID-19 Test Results-Reporting System for a School District Primarily Serving Underrepresented Minority Groups, San Diego, CA, 2021-2022. Am J Public Health. 2022 Nov;112(S9):S883-S886. doi: 10.2105/AJPH.2022.307073. Epub 2022 Oct 20.
PMID: 36265090BACKGROUNDKiene SM, McDaniels-Davidson C, Lin CD, Rodriguez T, Chris N, Bravo R, Moore V, Snyder T, Arechiga-Romero M, Famania-Martinez L, Carbuccia J, Pinuelas-Morineau R, Oren E. At-Home Versus Onsite COVID-19 School-based Testing: A Randomized Noninferiority Trial. Pediatrics. 2023 Jul 1;152(Suppl 1):e2022060352F. doi: 10.1542/peds.2022-060352F.
PMID: 37394511RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Assistant Vice President for Research Support Services
- Organization
- San Diego State University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 3, 2021
First Posted
December 9, 2021
Study Start
October 17, 2021
Primary Completion
April 2, 2022
Study Completion
April 2, 2022
Last Updated
January 17, 2025
Results First Posted
January 17, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.