dbGaP Study Accession: phs002662

NIH Institute/Center: NIGMS

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/v9jf-fj56

Updated Date: 04/17/2024

Study Description: West Virginia (WV) is rated by Becker's Hospital Review as the state with the sixth most vulnerable population to the novel coronavirus (SARS-CoV-2) while a second group at Wallethub, using three key domains (medical, housing, and financial), rates WV as the most vulnerable state to SARS-CoV-2 impact. Central to the state's extreme vulnerability is the high prevalence of obesity, cardiovascular disease including hypertension, chronic lung disease due to smoking and environmental exposure (e.g., mining), diabetes mellitus, and cancer. Additionally, WV is among the three states having the highest proportion of persons >age 65 years (20%). Through school and university closures in March 2020, along with shutdown of non-essential businesses, WV had relatively few COVID-19 cases and deaths until July 2020 when transmissibility (Rt) skyrocketed. Testing remains problematic in WV for multiple reasons, including inadequate testing supplies, accessibility to testing sites (given the rurality of the state and lack of widespread public transportation), shortages of personal protective equipment for staff, and lack of insurance coverage for surveillance testing and for uninsured persons. The West Virginia Clinical and Translational Science Institute (WVCTSI) submitted this application in partnership with multiple organizations with which they have existing collaborative relationships, including: 1) the WV Practice Based Research Network (PBRN), a 107 site primary care network spanning the state, 2) the WV Department of Health and Human Resources, 3) the WV National Guard, 4) West Virginia University (WVU) Health Sciences Center and College of Engineering, and 5) the Communities of Color. Vulnerable populations included individuals in rural communities and African American populations as well as those with comorbidities known to increase risk of severe COVID-19. Given the high prevalence of substance use disorder (SUD) in WV, a cross-cutting theme was ensuring persons with SUD are included in all proposed strategies to increase SARS-CoV-2 testing. COVID-19 testing disparities were addressed through achievement of the following specific aims, all of which use nucleic acid polymerase chain reaction testing on nasal or nasopharyngeal swabs: 1) Enhance COVID-19 testing among rural primary care offices located across WV, 2) Intensify COVID-19 testing through mobile vans in areas forecasted to experience a near-term increase in COVID-19 incidence, and 3) Increase COVID-19 testing in Black or African American communities through a dedicated mobile van and home testing. Evaluation of implemented strategies included assessing numbers of tests performed, uptake of home testing, satisfaction surveys, and structured interviews among Black or African Americans enrolled in the home testing study.

Principal Investigator: Hodder, Sally Lynn

Has Data Files: Yes

Study Domain: Mobile Unit Testing; Substance Use; Comorbidities; Self-Testing (At-Home or OTC)

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

Keywords: Cancer; Diabetes; Obesity; Comorbid Populations

Study Design: Cross-Sectional

Multi-Center Study: FALSE

Data Types: Questionnaires/Surveys; Other

Data Types, Other: Data for Aim One obtained from the West Virginia Department of Health and Human Resources

Study Start Date: 09/22/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 300

Study Population Focus: Adults; Underserved/Vulnerable Population; Older Adults or Elderly; Racial and Ethnic Minorities; African American; Rural Communities; Children

Publication URL: https://pubmed.ncbi.nlm.nih.gov/34731188/; https://pubmed.ncbi.nlm.nih.gov/33812965/; https://pubmed.ncbi.nlm.nih.gov/36764116/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10148293/; https://pubmed.ncbi.nlm.nih.gov/36265093/

Acknowledgement Statement: This study was supported through funding, 3U54GM104942-05S3, for the National Institute of General Medical Sciences (NIGMS) as part of the RADx-UP program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002662.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: PA-20-135

NIH Grant or Contract Number(s): 3U54GM104942-05S3

Consent/Data Use Limitations: General Research Use