Communities Fighting COVID Return to School

NCT ID: NCT05150860

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 852 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-17
• Study Completion Date: 2022-04-02

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

At-home testing

At-home COVID-19 testing model

Group Type: EXPERIMENTAL

At-home COVID-19 testing

Intervention Type: BEHAVIORAL

At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff

On-site testing

On-site COVID-19 testing model

Group Type: ACTIVE_COMPARATOR

Onsite COVID-19 testing

Intervention Type: BEHAVIORAL

Onsite COVID-19 testing for middle school students and staff

Interventions

At-home COVID-19 testing

At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff

Intervention Type: BEHAVIORAL

Onsite COVID-19 testing

Onsite COVID-19 testing for middle school students and staff

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

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

NIH

Sponsor Role: collaborator

Responsible Party

Susan M Kiene

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sweetwater Union High School District

Chula Vista, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36265090 (View on PubMed)

Kiene 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.

Reference Type: RESULT

PMID: 37394511 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Study Documents

Document Type: COVID Rapid Acceleration of Diagnostics (RADx) Data Hub

Data from this study is available on the RADx Data Hub

View Document

Other Identifiers

1OT2HD108112-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS-2021-0208

Identifier Type: -

Identifier Source: org_study_id