Communities Fighting COVID Return to School

Purpose

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.

Condition

  • COVID-19

Eligibility

Eligible Ages
Over 2 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 2 years of age or older; student at a Sweetwater Union High School District Middle School, staff at a Sweetwater Union High School District Middle School or household member of a student or staff affiliated with a Sweetwater Union High School District Middle School

Exclusion Criteria

  • <2 years of age - No affiliation with a Sweetwater Union High School District Middle School

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
At-home testing + household 		At-home COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
  • Behavioral: At-home COVID-19 testing
    At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff
  • Behavioral: Family-based model
    Making the COVID-19 testing program available to household/family members to increase participation of students and staff in the school COVID-19 testing program
Active Comparator
On-site testing + household 		On-site COVID-19 testing model with active encouragement of household member participation in regular COVID-19 testing part way through the trial
  • Behavioral: Family-based model
    Making the COVID-19 testing program available to household/family members to increase participation of students and staff in the school COVID-19 testing program
  • Behavioral: Onsite COVID-19 testing
    Onsite COVID-19 testing for middle school students and staff
Active Comparator
On-site testing 		On-site COVID-19 testing model, no active encouragement of household member participation in COVID-19 testing
  • Behavioral: Onsite COVID-19 testing
    Onsite COVID-19 testing for middle school students and staff

Recruiting Locations

More Details

NCT ID
NCT05150860
Status
Completed
Sponsor
San Diego State University

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.