dbGaP Study Accession: phs003031

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/kha0-tt06

Release Date: 08/29/2023

Updated Date: 04/17/2024

Study Description: 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 utilized daily wastewater and surface (floor) environmental monitoring to detect asymptomatic SARS-CoV-2 infections among students and staff on campus. Positive environmental signals were immediately followed by targeted responsive testing for a whole school (in the case of wastewater) or classroom (for a positive surface sample). This project developed the Safer at School Early Alert School-Neighborhood Asset Portal (SASEA- SNAP), an online school environmental monitoring report dashboard with resources to address structural barriers to COVID-19 diagnostic testing in historically marginalized communities (Aim 1). This study also created a toolkit to allow any school to rapidly adapt the template to their specific setting. In Aims 2 and 3, the study used a randomized stepped wedge trial to compare SASEA (control) vs SASEA-SNAP (intervention) in 50 schools across 4 diverse school clusters in San Diego County. The primary outcome (Aim 2) was higher rates of diagnostic testing in intervention schools. The secondary outcome (Aim 3) was increased risk mitigation behaviors in school community members when environmental surveillance data suggested a potential case on campus. In Aim 4, the study used 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.

Principal Investigator: Fielding-Miller, Rebecca Kathleen

Has Data Files: Yes

Study Domain: COVID in School Settings; Wastewater Surveillance; Virological Testing; Testing Rate/Uptake

Data Collection Method: Survey; Interview or Focus Group

Keywords: Families/Legal Guardians of School-aged Children/Young Adults; School Staff/Stakeholders; Individual-Level Data; Surface Environmental Monitoring; Marginalized Communities; School-Aged Children/Young Adults

Study Design: Longitudinal Cohort

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Other

Data Types, Other: Parent-child interview data, Focus group data

Study Start Date: 01/07/2022

Study End Date: 12/31/2023

Species: Human Data

Estimated Cohort Size: 1800

Study Population Focus: Children; School Community Members; Adults; Children; Hispanic and Latino

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05642000

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9851949/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9437384/

Acknowledgement Statement: This study was supported through funding, 4U01HD108787-02\, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We are deeply grateful to the leadership, staff, students, and families at our partner school districts and school sites across San Diego County. We thank our colleagues at the County of San Diego, Health and Human Services Agency for their vision and support. We thank student and staff researchers at the University of California - San Diego, for providing vital support with project implementation. Rebecca Fielding-Miller thanks Ms. Esther Krohne for inspiring the project. Approved users should acknowledge the provision of data access by dbGaP for accession phs003031.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: RFA-OD-21-008

NIH Grant or Contract Number(s): 4U01HD108787-02

Consent/Data Use Limitations: General Research Use