dbGaP Study Accession: phs002616

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/c7y1-s751

Release Date: 08/31/2023

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.

Updated Date: 04/17/2024

Principal Investigator: Schoenthaler, Antoinette M

Has Data Files: Yes

Study Domain: Health Behaviors; Pandemic Perceptions or Decision-Making; Social Determinants of Health; Testing Rate or Uptake; Vaccination Rate or Uptake

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

Keywords: Testing Disparities

Study Design: Cross-Sectional

Multi-Center Study: No

Data Types: Behavioral; Clinical; Electronic Medical Records; Environmental; Psychological; Questionnaire or Survey; Social

Study Start Date: 11/01/2020

Study End Date: 05/12/2023

Species: Human

Estimated Cohort Size: 500

Study Population Focus: Adults; African Americans; Hispanics or Latinos; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Racial or 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