COVID-19
Conditions
Brief summary
Schools serve important community roles beyond academic education. In historically marginalized communities they are trusted providers for a range of support services for families in need. The tradeoff between these crucial benefits of in-person learning against the risk of SARS-CoV-2 transmission in school settings has been hotly debated throughout much of 2020 and 2021. The stakes are particularly high in historically marginalized communities which rely most heavily on school services, but have also been hit the hardest by COVID-19 primarily due to structural issues. The Safer at School Early Alert (SASEA) program was co-developed by the University of California, San Diego, the County of San Diego, and 15 partner schools serving socially vulnerable students in 5 school districts across San Diego County. SASEA utilizes daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals are immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). In this project, we will develop the Safer at School Early Alert HUB (SASEA HUB), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). We will also create a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, we will use a randomized stepped wedge trial to compare SASEA (control) vs SASEA HUB (intervention) in 26 schools across 3 diverse school clusters in San Diego County. Our primary outcome (Aim 2) is higher rates of diagnostic testing in intervention schools. Our secondary outcome (Aim 3) is increased risk mitigation behaviors in school community members when environmental surveillance data suggests a potential case on campus. In Aim 4, we will use parent-child narrative interviews with 40 parent-student pairs to understand how children perceive COVID-19 risk at school, assess differences in perceptions of testing barriers between intervention and control sites, and better understand how children understand the process of environmental surveillance and responsive testing.
Interventions
BEHAVIORALSASEA HUB
SASEA HUB website, an intervention tool to increase COVID-19 testing
Sponsors
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Individuals ages 18 and above affiliated with students attending the 3 school districts participating in the SASEA study
Exclusion criteria
* Children under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Completed a COVID-19 Test | 14 days | The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals. |
Countries
United States
Participant flow
Recruitment details
Only parents were considered enrolled in the study. Staff who were also parents of children who attended the school were also recruited to complete the survey but they are completing the survey in their role as a parent and not as a staff of the school
Participants by arm
| Arm | Count |
|---|---|
| SASEA HUB Access to online COVID-19 information tool hub to support testing access
SASEA HUB: SASEA HUB website, an intervention tool to increase COVID-19 testing | 917 |
| Control School specific standard of care for COVID-19 | 0 |
| Total | 917 |
Baseline characteristics
| Characteristic | Total | SASEA HUB |
|---|---|---|
| Age, Continuous | 35.6 Years STANDARD_DEVIATION 8.6 | 35.6 Years STANDARD_DEVIATION 6.7 |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 917 participants | 917 participants |
| Sex: Female, Male Female | 809 Participants | 809 Participants |
| Sex: Female, Male Male | 108 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 917 | 0 / 0 |
| other Total, other adverse events | 0 / 917 | 0 / 0 |
| serious Total, serious adverse events | 0 / 917 | 0 / 0 |
Outcome results
Primary
Percentage of Participants Who Completed a COVID-19 Test
The primary study endpoint will be student diagnostic testing uptake in the previous 14-days, measured using household surveys distributed at 2-week intervals.
Time frame: 14 days
Population: Parents and staff in SASEA Hub participating schools
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SASEA HUB | Percentage of Participants Who Completed a COVID-19 Test | 0.44 percentage of participants |
| Control | Percentage of Participants Who Completed a COVID-19 Test | 0.40 percentage of participants |
95% CI: [-0.079, 0.454]Mixed Models Analysis