dbGaP Study Accession: phs002871

NIH Institute/Center: NIAID

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/1tqv-dv25

Study Description: This study sought to understand the factors associated with COVID-19 morbidity and mortality disparities and to lay the foundation to reduce disparities for those underserved and vulnerable populations that are disproportionately affected by, have the highest infection rates of, and/or are most at risk for adverse outcomes from the COVID-19 pandemic. This implementation study assessed the modality and venue preferences for COVID 19 testing in rural, incarcerated, and other underserved populations in the state of Alabama. The objective of the study was to evaluate the implementation of a rapid scale-up SARS CoV-2 testing strategy. The original goal of the study was to conduct 30,000 tests in rural counties statewide. In Aim 1, the study defined higher case burden as counties with more than 25 daily cases of COVID-19 per 100,000 total population and lower case burden as less than 10 daily cases per 100,000, both using a 7-day average. In order to identify communities particularly vulnerable to morbidity and disease spread, age, race, income and education were mapped based on census data; and the COVID vulnerability index which included social determinants of health as well as data regarding healthcare access, and COVID-19 disease risk factors. The study also mapped areas where mitigation efforts are particularly poor via cell phone movement and a surrogate measure of belief in COVID-19 science and public policy recommendations. These data were used to work with community partners to prioritize rural counties for testing delivery. All analyses used publicly available aggregate data and did not enroll individuals. As such, these Aim 1 data were not transmitted to the CDCC. For Aim 2, the study partnered with a third-party survey vendor to collect the full battery of Tier 1 Common Data Elements (CDEs) required for the project. The survey sample (n~300) was a representative sample of the rural populations from various counties in which the tests were administered. This data was uploaded to the CDCC including all required CDEs. For Aim 3, in collaboration with community partners, specifically the Alabama Area Health Education Centers (AHEC), the study administered COVID-19 tests within underserved rural populations statewide. All told from 10/01/20 until 02/28/22, the study administered over 23,000 PCR tests, which resulted in a 12% positivity rate. This included testing with the Visby point-of-care PCR test developed via RADx-TECH, which had particular uptake in rural jails across Alabama. In accordance with DHHS reporting requirements, this study collected basic demographic data from all those who were tested, including race, gender, and age. As approved by NIH, this limited dataset was provided for all persons tested via this project, but not all CDEs, as testing was done as standard of care and not for research purposes. Aim 4 of the study evaluated the effectiveness of the testing initiative’s implementation strategy, which was completed by June 2022. This study wanted to know how appropriate and feasible the testing initiative has been for those involved. The target population for this aim of the study were researchers, administrators, and testing staff who have been involved in the project, and did not include the general population and communities offered testing services. As such, there was no individual-level data capture aligned with the CDCC CDE model. This study collected over 100 surveys and conducted 50 in-depth interviews for this aim.

Updated Date: 04/17/2024

Principal Investigator: Saag, Michael S

Has Data Files: Yes

Study Domain: Social Determinants of Health

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

Keywords: Individual-Level Data; COVID-19 Morbidity Rates; COVID-19 Mortality Rates; Testing Effectiveness

Study Design: Cross-Sectional

Multi-Center Study: FALSE

Data Types: Behavioral; Questionnaires/Surveys; Clinical

Study Start Date: 09/23/2020

Study End Date: 08/31/2022

Species: Human Data

Estimated Cohort Size: 35000

Study Population Focus: Adults; Rural Communities; Underserved/Vulnerable Population; Older Adults or Elderly; Children; Incarcerated/Institutionalized (or Criminal Legal System Involvement)

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35952331/

Acknowledgement Statement: This study was supported through funding, 3P30AI027767-33S1, for the National Institute of Allergy and Infectious Diseases (NIAID) as part of the RADx-UP program. We would like to acknowledge support from the Center for AIDS Research. The University of Alabama at Birmingham's Research and Informatics Services Center (RISC) within the Division of Infectious Diseases at the Heersink School of Medicine managed this project, including its research components. RISC partnered with many local organizations, including ConnectionHealth, Acclinate Genetics, the Alabama Quality Management Group, and the Alabama Area Health Education Centers to plan and implement a robust testing strategy in many rural, incarcerated, and other underserved populations in the state. Approved users should acknowledge the provision of data access by dbGaP for accession phs002871.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): 3P30AI027767-33S1

Consent/Data Use Limitations: General Research Use