Communities Fighting COVID Return to School

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Behavioral: At-home COVID-19 testing
* Behavioral: Family-based model
* Behavioral: Onsite COVID-19 testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: At-home testing + household<br>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<br>* At-home over-the-counter (OTC) COVID-19 testing kits provided to middle school students and staff<br>Behavioral: Family-based model<br>* 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<br>|
| Active Comparator: On-site testing + household<br>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<br>* 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<br>Behavioral: Onsite COVID-19 testing<br>* Onsite COVID-19 testing for middle school students and staff<br>|
| Active Comparator: On-site testing<br>On-site COVID-19 testing model, no active encouragement of household member participation in COVID-19 testing | Behavioral: Onsite COVID-19 testing<br>* Onsite COVID-19 testing for middle school students and staff<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation rate | Percentage of students and staff who participate in testing per the testing schedule (e.g., weekly testing) | through trial completion, expected to be approximately 5 months | 
| Adherence to the testing schedule | Percentage of scheduled tests completed | through trial completion, expected to be approximately 5 months |