Study Information

dbGaP Study Accession: phs002651

NIH Institute/Center: NIDA; NIMHD

RADx Data Program: RADx-UP

DOI: 10.60773/gvj9-b203

Release Date: 08/31/2023

Updated Date: 04/17/2024

Study Description: The SARS-CoV-2, also known as COVID-19, pandemic has caused disastrous and unprecedented public health and economic consequences in the U.S., seriously affecting Americans' physical and mental health. Death rates attributable to COVID-19 among minority populations are several folds higher than among predominantly White counties. South Florida and specifically Miami-Dade County is an epicenter of the COVID-19 pandemic, where non-Hispanic Blacks and Latinos are overrepresented in COVID-19 related hospitalizations and deaths. Pervasive structural inequities and social determinants of health are the main cause of health disparities due to a complex interaction of multiple factors including individual and societal risk factors. Understanding the impacts of these factors on health and social consequences of the pandemic has broad policy implications, especially for the acceptance of testing and future vaccines. This research helps address the impact of COVID-19 on vulnerable minority populations and examined: (1) the barriers to testing and uptake of future vaccines, (2) effectiveness of community engagement to increase the uptake of COVID-19 testing in the underserved communities, (3) acceptability, sensitivity and specificity of using less invasive testing methods compared to nasopharyngeal swabs, and (4) assessment of barriers and potential strategies to engage community members and community organizations in COVID-19 testing and vaccine deployment. Community-engaged research studies (in collaboration with community-based partners) were conducted to: (a) determine barriers to testing, and uptake of future vaccines, including health literacy, stigma, drug use and financial burden associated with testing, follow-up care, feasibility of effective self-isolation if positive, and perceived effectiveness of testing and vaccination, (b) assessment of the acceptability of extensive community outreach and deployment of a mobile COVID-19 testing unit to geographical areas occupied by underserved and vulnerable populations in close proximity to a community partner, Borinquen Health Care Center (BHCC), and (c) compare the acceptability, sensitivity, and specificity of alternative approaches to obtain samples, including medically administered nasopharyngeal swabs and saliva. The goal was to improve understanding of COVID-19-related health disparities; enhance access, effectiveness, and implementation of COVID-19 testing in vulnerable and/or underserved populations; and to mobilize the community to develop culturally-appropriate strategies to mitigate the COVID-19 epidemic and increase acceptance of future vaccines. The potential for evidence-based approaches to address COVID-19 disparities was facilitated by community-based partners that have the resources to provide community engagement, follow-up care, and public health mitigation for cases who test positive; the PI who managed a CLIA-certified laboratory at the university and a research team experienced in recruiting and retaining >1,000 study participants from the same vulnerable and underserved populations.

Principal Investigator: Baum, Marianna K

Has Data Files: Yes

Study Domain: Social Determinants of Health; Community Outreach Programs; Testing Rate/Uptake; Pandemic Perceptions and Decision-Making; Vaccination Rate/Uptake; Mobile Unit Testing

Data Collection Method: Survey

Keywords: COVID-19-related Health Disparities; Testing Disparities

Study Design: Qualitative

Multi-Center Study: FALSE

Study Sites: FIU Research Clinic

Data Types: Other; Questionnaires/Surveys

Data Types, Other: Questionnaires and Surveys that are part of the Common Data Elements (CDEs)

Study Start Date: 09/30/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 3034

Study Population Focus: Adults; Racial and Ethnic Minorities; Older Adults or Elderly; African American; Hispanic and Latino

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9444299/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8132028/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217089/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8745607/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8837482/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8891146/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9225925/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9266638/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9535877/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9962547/; https://pubmed.ncbi.nlm.nih.gov/33675620/; https://pubmed.ncbi.nlm.nih.gov/34009479/; https://pubmed.ncbi.nlm.nih.gov/34998257/; https://pubmed.ncbi.nlm.nih.gov/35008706/; https://pubmed.ncbi.nlm.nih.gov/35331580/; https://pubmed.ncbi.nlm.nih.gov/35331581/; https://pubmed.ncbi.nlm.nih.gov/35779987/; https://pubmed.ncbi.nlm.nih.gov/35805866/; https://pubmed.ncbi.nlm.nih.gov/36123252/; https://pubmed.ncbi.nlm.nih.gov/36171158/; https://pubmed.ncbi.nlm.nih.gov/36266158/; https://pubmed.ncbi.nlm.nih.gov/36837890/

Acknowledgement Statement: This study was supported through funding, 3U01DA040381-05S2 and 5U01MD017423-02, from the National Institute on Drug Abuse (NIDA) and the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. We would like to acknowledge all the participants in the study, without whom advancement in the prevention and management of COVID-19 would not be possible. We also thank the FIU Neighborhood HELP and Borinquen Health Care Center, for their collaboration and provision of resources without which this study would not have been feasible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002651.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): 3U01DA040381-05S2; 1U01MD017423-01

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002651_Project 18_Protocol.pdf230.00 KB
Study Documentationphs002651_Project 87_Protocol.pdf1.54 MB
READMEproject18_README.html281.67 KB
READMEproject87_README.html281.66 KB
Data Files
Total Files: 12
Data Files: 4
Metadata Files: 4
Dictionary Files: 4
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project18_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1760
project18_DATA_transformcopy.csvTabular Data - Harmonizedcsv1760
project87_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1463
project87_DATA_transformcopy.csvTabular Data - Harmonizedcsv1463