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
| Arm | Description | Assigned 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 |
|
|
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 |
|
|
Active Comparator On-site testing |
On-site COVID-19 testing model, no active encouragement of household member participation in COVID-19 testing |
|
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.