Study Information

dbGaP Study Accession: phs002761

NIH Institute/Center: NCATS

RADx Data Program: RADx-UP

DOI: 10.60773/869q-b786

Release Date: 08/30/2023

Updated Date: 04/17/2024

Study Description: The novel coronavirus that causes COVID-19 has negatively impacted global health status and economies worldwide. In the U.S., vulnerable populations experience significant disparities in terms of both infection and mortality rates, especially in the State of Texas, where Hispanic, African American, and other groups have experienced substantial disparities in both incidence and mortality. For example, Hispanics comprise 29.4% of the state's population, but 40.1% of COVID-19 cases and 47.9% of confirmed fatalities. The communities prioritized in this study include populations with medical comorbidities and those experiencing homelessness, and underserved Hispanics and African Americans in three racially diverse regions: South Texas, Houston/Harris County, and Northeast Texas. All of these regions are experiencing crisis-level surges in COVID-19 cases and fatalities. Testing disparities in Texas are evident, but understudied, and rapid deployment and evaluation of prevention, diagnostic, and mitigation strategies is imperative. Building on the partnerships and resources of the UTHealth Center for Clinical and Translational Science (CCTS), the goal of this study was to partner with community and stakeholder colleagues to identify dynamic disease hotspots and testing deserts in racially diverse neighborhoods of the target regions and to use that information to inform the rapid adaptation and deployment of multilevel level just-in-time adaptive intervention strategies to reach vulnerable populations. This study accomplished the following aims: 1) Identify disparities and dynamics of SARS-CoV-2 testing and infections in three Texas regions by (i) estimating real-time testing availability and uptake patterns utilizing data from regional health departments and hospital records; (ii) estimating real-time disparities in incidence rate and positive test rate of SARS-CoV-2 infections and COVID-19, and (iii) identifying, characterizing and predicting dynamic disease hotspots and testing deserts in vulnerable communities utilizing spatial-temporal modeling approaches. 2) Use multilevel network modeling methods to examine the structural properties of interorganizational networks; and apply network optimization methods to identify influential organizations that can maximize system-level organizational performance to better coordinate local testing and service delivery needs. 3) Engage CCTS community networks to develop, implement and evaluate a targeted, adaptive multilevel intervention to increase reach, uptake, implementation, and sustainment of SARS-CoV-2 diagnostics among priority vulnerable populations. This study evaluated the reach, effectiveness and implementation of the Community level Just-In-Time Adaptive Interventions (Community JITAIs) to increase SARs-CoV-2 testing and reduce infections in identified high risk priority neighborhoods, and conducted an embedded study to evaluate the use of community health worker-delivered SARS-CoV-2 diagnostics. This work was continued in Phase II of the funding by examining the aims in light of the COVID-19 vaccine being available to the populations of interest.

Principal Investigator: Mcpherson, David D

Has Data Files: Yes

Study Domain: COVID Hotspots; COVID Testing Deserts; Virological Testing; Community Outreach Programs; Testing Rate/Uptake; Comorbidities

Data Collection Method: Survey

Keywords: COVID Hotspot Communities; Comorbid Populations; Comorbid Populations

Study Design: Cross-Sectional

Multi-Center Study: TRUE

Study Sites: The University of Texas Health Science Center Houston; The University of Texas Health Science Center at Tyler

Data Types: Psychological; Questionnaires/Surveys; Behavioral; Clinical; Social

Study Start Date: 09/24/2020

Study End Date: 06/30/2024

Species: Human Data

Estimated Cohort Size: 980

Study Population Focus: Underserved/Vulnerable Population; Adults; Racial and Ethnic Minorities; Homeless/Unhoused; Hispanic and Latino; African American; Older Adults or Elderly

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05606003

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9987191/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354426/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8767157/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9127615/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9178652/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9755943/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532394/

Acknowledgement Statement: This study was supported through funding, 3UL1TR003167-04S2, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-UP program. We would like to thank the participants who resided in Northeast Texas, South Texas and Harris County, Texas. We would also like to thank the community partners, investigators, and staff for their dedication to completing the project and improving testing outcomes in under-served communities. Approved users should acknowledge the provision of data access by dbGaP for accession phs002761.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): 3UL1TR003167-04S2

Consent/Data Use Limitations: General Research Use

Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002761_Project 38_Protocol_06NOV2020.pdf629.68 KB
Study Documentationphs002761_Project S15_Protocol.pdf590.04 KB
READMEproject38_README.html281.48 KB
READMEprojectS15_README.html281.40 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
project38_DATA_transformcopy.csvTabular Data - Harmonizedcsv358
project38_DATA_origcopy.csvTabular Data - Non-harmonizedcsv358
projectS15_DATA_transformcopy.csvTabular Data - Harmonizedcsv1019
projectS15_DATA_origcopy.csvTabular Data - Non-harmonizedcsv1019