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The Safer At School Early Alert HUB

NCT ID: NCT05642000

Last Updated: 2024-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1029 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-19

Study Completion Date

2022-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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SASEA HUB

Access to online COVID-19 information tool hub to support testing access

Group Type EXPERIMENTAL

SASEA HUB

Intervention Type BEHAVIORAL

SASEA HUB website, an intervention tool to increase COVID-19 testing

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SASEA HUB

SASEA HUB website, an intervention tool to increase COVID-19 testing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Fielding-Miller

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

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Other Identifiers

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1U01HD108787-01

Identifier Type: NIH

Identifier Source: org_study_id

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