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OpenTrials
Completed

NCT Number: NCT05150860

Communities Fighting COVID Return to School

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sweetwater Union High School District

Chula Vista, California, 91911, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

At-home COVID-19 testing

Behavioral

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

Onsite COVID-19 testing

Behavioral

Onsite COVID-19 testing for middle school students and staff

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2021
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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