dbGaP Study Accession: phs002616
NIH Institute/Center: NIMHD
RADx Data Program: RADx-UP
Release Date: 08/31/2023
DOI: 10.60773/c7y1-s751
Updated Date: 04/17/2024
Study Description: The COVID-19 pandemic is a major public health crisis, revealing deep and persistent racial/ethnic disparities in health. In New York City (NYC), one of the most affected cities in the U.S., Black and Latinx communities suffered the highest rates of hospitalizations and mortality from COVID-19. Age-adjusted death rates for Blacks are more than twice those for Whites across the U.S. Data suggest that this may even represent a gross underestimate of the magnitude of the mortality from COVID-19 because Blacks and Latinx are less likely than their White counterparts to be tested for COVID-19. Delayed testing and lack of testing among high-risk individuals significantly increases the spread of the virus, and is associated with reduced ability to access life-saving treatment. Without an understanding of the complex and interrelated factors that occur at multiple levels of influence, existing testing strategies may fail to serve populations most vulnerable to COVID-19 morbidity, particularly poor and minority populations. As such, partnerships with Federally Qualified Health Centers (FQHCs), where most Blacks and Latinx people receive care, are urgently needed. The FHCs at NYULH, which is the nation's second largest network of FQHCs, is a unique platform to address this problem. This three-phase study employed a multipronged, sequential mixed methods design (i.e., one methodology builds on the findings of the other) to gain a comprehensive understanding of the multilevel factors that drive uptake of testing (and vaccination) for COVID-19 in Black and Latinx patients (primary outcome), and participation in follow-up care offered by safety-net health systems. Phase 1 leveraged the FHC electronic health record (EHR) database to quantitatively examine individual-level sociodemographic, clinical, and healthcare utilization factors associated with receiving a PCR test for COVID-19 among 400 Black and Latinx patients who receive care at the FHCs. This phase also captured the community- and structural-level determinants of testing using validated self-report measures (RADX-UP Common Data Elements, NIH PhenX Toolkit) among the same patients (Aim 1). In Phase 2, the data sources from Phase 1 were coupled with qualitative data (e.g., focus groups, ethnographic observation, and document analysis) to capture organizational and ethical issues to shed light on important social, cultural, and contextual factors associated with uptake of COVID-19 testing and potential vaccine (Aim 2). In partnership with the Community Oversight Task Force (COTF), in Phase 3, data obtained from Phases 1 and 2 were integrated and used to refine, test, and disseminate data governance guidelines, and tailored toolkits about COVID-19 testing and vaccines (Aim 3). This study contributed to the scientific knowledge about the testing attitudes and behaviors of vulnerable communities to lay the foundation for implementing outreach strategies to increase the delivery of timely testing and follow-up among minority communities in the short-term and generate important data for large-scale COVID-19 testing and vaccination initiatives in the long-term.
Principal Investigator: Schoenthaler, Antoinette M
Has Data Files: Yes
Study Domain: Vaccination Rate/Uptake; Social Determinants of Health; Testing Rate/Uptake; Health Behaviors; Pandemic Perceptions and Decision-Making
Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device; Survey; Interview or Focus Group
Keywords: Testing Disparities
Study Design: Cross-Sectional
Multi-Center Study: FALSE
Data Types: Environmental (Physical); Electronic Medical Records; Clinical; Other; Questionnaires/Surveys; Psychological; Social; Behavioral
Data Types, Other: Qualitative
Study Start Date: 11/01/2020
Study End Date: 05/12/2023
Species: Human Data
Estimated Cohort Size: 500
Study Population Focus: African American; Hispanic and Latino; Lower Socioeconomic Status (SES) Population; Adults; Older Adults or Elderly; Racial and Ethnic Minorities
ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT03713515
Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8214153/
Acknowledgement Statement: This study was supported through funding, 5R01MD013769-05, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002616.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: PAR-18-286
NIH Grant or Contract Number(s): 5R01MD013769-05
Consent/Data Use Limitations: General Research Use