The Safer At School Early Alert HUB (SASEA HUB)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Behavioral: SASEA HUB

• Study Type: Interventional
• Enrollment (Actual): 1029
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: SASEA HUB; Access to online COVID-19 information tool hub to support testing access	Behavioral: SASEA HUB; SASEA HUB website, an intervention tool to increase COVID-19 testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): December 17, 2022

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1U01HD108787-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No