MedPath

Communities Fighting COVID Return to School

Not Applicable
Completed
Conditions
COVID-19
Interventions
Behavioral: At-home COVID-19 testing
Behavioral: Family-based model
Behavioral: Onsite COVID-19 testing
Registration Number
NCT05150860
Lead Sponsor
San Diego State University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
852
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
At-home testing + householdFamily-based modelAt-home COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
On-site testing + householdFamily-based modelOn-site COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
On-site testing + householdOnsite COVID-19 testingOn-site COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
At-home testing + householdAt-home COVID-19 testingAt-home COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
On-site testingOnsite COVID-19 testingOn-site COVID-19 testing model, no active encouragement of household member participation in COVID-19 testing
Primary Outcome Measures
NameTimeMethod
Adherence to the Weekly COVID-19 Testing Schedulethrough study completion, up to 21 weeks

Proportion of scheduled weekly COVID-19 tests completed when enrolled in the trial

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Sweetwater Union High School District

🇺🇸

Chula Vista, California, United States

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