dbGaP Study Accession: phs002759

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/y7xk-ma85

Release Date: 08/30/2023

Study Description: This proposal tested the hypothesis that frequent screening testing would provide additional benefit, beyond current school-based mitigation strategies, to prevent SARS-CoV-2 transmission. This study completed a cluster randomized trial to compare the incidence of school-based SARS-CoV-2 transmission between weekly surveillance testing of students and school staff versus testing only symptomatic students and staff. In this proposal, 12 middle and high schools from five predominantly African-American school districts in the St. Louis metropolitan area were cluster randomized to screening testing plus symptomatic testing versus symptomatic testing alone. This study performed qualitative listening sessions and interviews with members of the school community including parents, teachers, administrators, and students to understand the facilitators and barriers to testing, the concerns regarding in-person school, and potential issues involving vaccine hesitancy evident in all populations and groups. This study provided critically needed, rigorous data to inform the utility of screening testing in schools and if it is important in aiding schools in the African-American community to return to in-person instruction. Additionally, the measurements of school-based transmission rates helped participating schools in the African-American community assess the impact of their mitigation strategies, demonstrated potential risk points for transmission that can be targeted for further intervention, and reassured the community on the safety of their schools. Finally, the study results aided participating researchers, school districts and communities in understanding how to mitigate concerns about in-person schooling and the reliability of the mitigation strategies (with or without screening testing) in preventing COVID-19 transmission.

Updated Date: 04/17/2024

Principal Investigator: Newland, Jason

Has Data Files: Yes

Study Domain: COVID in School Settings; Pandemic Perceptions or Decision-Making; Screening Testing; Social Determinants of Health

Data Collection Method: Interview or Focus Group; Molecular Nucleic Acid or PCR Testing Device; Survey

Keywords: COVID Transmission Rates; Families/Legal Guardians of School-aged Children/Young Adults; Return to In-person Learning; School Staff/Stakeholders; School-aged Children/Young Adults; School-based Testing; Vaccine Hesistancy

Study Design: Case-Control

Multi-Center Study: No

Data Types: Questionnaire or Survey

Study Start Date: 04/01/2021

Study End Date: 03/31/2023

Species: Human

Estimated Cohort Size: 5000

Study Population Focus: Adults; African Americans; Children; Children; Older Adults or Elderly; School Communities; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04875520

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737177/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737179/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737181/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/35698094/; https://pubmed.ncbi.nlm.nih.gov/36992895/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10040557/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9189793/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647737/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647738/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647774/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647777/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9647778/

Acknowledgement Statement: This study was supported through funding, 3OT2HD107557-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We want to acknowledge the community who has partnered with us on this work through engagement in so many different ways. We also want to acknowledge the team working to implement and execute this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002759.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.

NIH Grant or Contract Number(s): 3OT2HD107557-01S1

Consent/Data Use Limitations: General Research Use