dbGaP Study Accession: phs002878

NIH Institute/Center: NICHD

RADx Data Program: RADx-UP

DOI: 10.60773/qyrm-p781

Release Date: 08/30/2023

Updated Date: 04/10/2024

Study Description: San Diego State University (SDSU), a designated Hispanic-serving institution, partnered with Sweetwater Union High School District, an independent public school district serving 90% ethnic minority and a high proportion of socioeconomically disadvantaged students, and other community partners, to generate evidence for effective and feasible COVID-19 testing for middle school students and staff as part of broader COVID mitigation strategies including vaccination to return students back to school safely. Specific aims were to: 1) determine if providing free at-home COVID-19 rapid antigen testing kits produces equivalent participation in school screening testing as on-site school testing; 2) evaluate if a family-based model of making testing available to family members enhances participation; 3) study implementation of the program to inform scale-up to additional schools; and 4) identify resources needed to ensure ongoing high participation rates.

Principal Investigator: Kiene, Susan Maria

Has Data Files: Yes

Study Domain: Screening Testing; Rapid Diagnostic Test (RDT); Self-Testing (At-Home or OTC); COVID in School Settings

Data Collection Method: Antigen Testing Device; Survey

Keywords: School-aged Children/Young Adults; Families/Legal Guardians of School-aged Children/Young Adults; School-based Testing; Return to In-person Learning

Study Design: Interventional/Clinical Trial

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys

Study Start Date: 07/21/2021

Study End Date: 10/13/2023

Species: Human Data

Estimated Cohort Size: 9000

Study Population Focus: Children; Lower Socioeconomic Status (SES) Population; Racial and Ethnic Minorities; Underserved/Vulnerable Population; School Community Members; Hispanic and Latino; Older Adults or Elderly; Adults

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05150860

Publication URL: https://pubmed.ncbi.nlm.nih.gov/36265090/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394511/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394502/; https://pubmed.ncbi.nlm.nih.gov/37394504/; https://pubmed.ncbi.nlm.nih.gov/35010795/

Acknowledgement Statement: This study was supported through funding, 3OT2HD108112-01S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. Communities Fighting COVID!: Returning Our Kids Back to School Safely was supported by PIs: Susan M. Kiene, Eyal Oren, Corinne McDaniels-Davidson. Communities Fighting COVID!: Returning Our Kids Back to School Safely acknowledges the invaluable contributions of the Sweetwater Union High School District, project staff, community members, and study participants. Approved users should acknowledge the provision of data access by dbGaP for accession phs002878.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): 3OT2HD108112-01S1

Consent/Data Use Limitations: General Research Use