Communities Fighting COVID Return to School

San Diego State University

Status: Completed

Conditions: COVID-19

Treatments: Behavioral: At-home COVID-19 testing; Behavioral: Onsite COVID-19 testing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05150860

HS-2021-0208

1OT2HD108112-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 852 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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852 participants in 2 patient groups

At-home testing

Experimental group

Description:

At-home COVID-19 testing model

Treatment:

Behavioral: At-home COVID-19 testing

On-site testing

Active Comparator group

Description:

On-site COVID-19 testing model

Treatment:

Behavioral: Onsite COVID-19 testing