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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SASEA HUB | Experimental | Access to online COVID-19 information tool hub to support testing access |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SASEA HUB | Behavioral | SASEA HUB website, an intervention tool to increase COVID-19 testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | United States |
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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
| ID | Title | Description |
|---|---|---|
| FG000 | Cluster 1 | SASEA HUB intervention after 2 week baseline data collection. 12 weeks of intervention exposure. |
| FG001 | Cluster 2 | SASEA HUB intervention arm after 2 weeks of baseline data collection (district began fall term two weeks later than Cluster 1). 10 weeks of intervention exposure |
| FG002 | Cluster 3 | SASEA HUB intervention after 6 weeks of baseline data collection. 8 weeks of intervention exposure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wave 1: Late September |
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| Wave 2: Early October |
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| Wave 3: Late October |
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| Wave 4: Early November |
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| Wave 5: Mid November |
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| Wave 6: Early December |
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| Wave 7: Late December |
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This was a stepped-wedge trial. Participants all started as controls and crossed over to the intervention - SASEA HUB
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Parents and staff in SASEA Hub participating schools | Posted | Number | 95% Confidence Interval | percentage of participants | 14 days |
|
Adverse event data were collected throughout the October to December only when schools were receiving the intervention. Adverse events were not monitored during the weeks where schools were receiving standard of care.
0 means - All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Fielding-Miller | University of California San Diego | 8583810603 | rfieldingmiller@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2024 | Apr 29, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2022 | Jul 19, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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School specific standard of care for COVID-19
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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|
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| 0 |
| 917 |
| 0 |
| 917 |
| 0 |
| 917 |
| EG001 | Control | School specific standard of care for COVID-19 | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |