Study Information

dbGaP Study Accession: phs002869

NIH Institute/Center: NCI

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/swwm-cp96

Study Description: Pronounced inequities and disparities in coronavirus disease (COVID-19) morbidity and mortality have been reported, largely due to comorbid conditions and social determinants of health. Approximately 95% of COVID-19 related deaths occur among individuals with underlying medical conditions. Of all racial/ethnic groups, Hispanic/Latino communities in San Diego County have experienced the greatest burden of COVID-19 disease and deaths. Furthermore, testing challenges to date are evident, including long turnaround of test results and longer waiting times for African American and Hispanics compared to whites. The goal of this community-engaged proposal was to develop, test, and evaluate a rapid, scalable capacity building project to enhance COVID-19 testing in three regional community health centers (CHCs) in San Diego County. In collaboration with CHC partners, their consortium organization (Health Quality Partners), and community stakeholders, the following Specific Aims were proposed: 1) Compare the effectiveness of automated calls and text messaging for uptake of COVID-19 testing among asymptomatic adult patients with select medical conditions and those 65 years of age and older receiving care at participating CHCs. Secondarily, all study participants were invited to receive flu vaccination and feasibility and acceptability of study participants to refer adult family household members who are essential workers for COVID-19 testing were assessed. 2) Gather patient, provider, CHC leadership, and community stakeholder insights to establish best practices for future scale-up of COVID-19 testing sustainability and vaccination. This community-engaged project included underserved (socioeconomically disadvantaged and large proportion of Hispanic/Latinos) as well as COVID-19 vulnerable individuals (patients with medical comorbidities and 65 years of age and older). The approach considered regional COVID-19 morbidity and mortality disparities to identify strategies to address disproportionate infection rates and follow-up. By working in partnership with health care providers, health care system leaders, and community stakeholders, this team had the potential to build evidence-based approaches and identify sustainable solutions to understand and address the current and future pandemics in these underserved and vulnerable populations.

Updated Date: 04/17/2024

Principal Investigator: Martinez, Maria Elena

Has Data Files: Yes

Study Domain: Diagnostic Testing; Influenza; Social Determinants of Health; Testing Rate or Uptake

Data Collection Method: Survey

Keywords: Asymptomatic Populations; COVID-19 Morbidity Rates; COVID-19 Mortality Rates; Individual-Level Data

Study Design: Interventional or Clinical Trial

Multi-Center Study: No

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

Study Start Date: 11/01/2020

Study End Date: 08/31/2023

Species: Human Data

Estimated Cohort Size: 6000

Study Population Focus: Adults; Children; Hispanics or Latinos; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; Underserved or Vulnerable Populations

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05315908

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8744798/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9662780/

Acknowledgement Statement: This study was supported through funding, 3UH3CA233314-02S1, for the National Cancer Institute (NCI) as part of the RADx-UP program. We would like to thank all researchers and staffs for their commitment and dedication to this study. We thank all research volunteers for their contribution through their participation in this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002869.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): 3UH3CA233314-02S1

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002869_Project 57_Protocol.pdf815.84 KB
READMEproject57_README.html274.51 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project57_DATA_transformcopy.csvTabular Data - Harmonizedcsv2620
project57_DATA_origcopy.csvTabular Data - Non-harmonizedcsv2620