dbGaP Study Accession: phs003687

NIH Institute/Center: NCATS

RADx Data Program: RADx-UP

Release Date: 09/13/2024

DOI: 10.60773/8e0v-pk44

Study Description: Vulnerable populations including those with medical comorbidities, people living in rural settings and minorities experience significant COVID-19 disparities. Additionally, Hispanics and Blacks are significantly more likely to be infected and hospitalized when compared to White, Non-Hispanics. This study built on RADx-UP Phases I & Phase II work reaching these populations in three racially diverse regions: Houston/Harris County, South Texas, and Northeast Texas to increase SARS-CoV-2 testing, vaccination, and risk mitigation behaviors to reduce COVID-19 morbidity, mortality, and inequities among underserved populations in Texas. The study leveraged the partnerships and resources of the Center for Clinical and Translational Science (CCTS) including long-standing community partnerships. Phase III included mixed methods and community-engaged approaches to inform adaptation of existing (and the development of new) multilevel intervention messages, materials and strategies with a focus on increasing rapid SARS-CoV-2 testing. It also included a broader focus on addressing the social determinants of health (SDOH) and an emphasis on combating misinformation. Innovative elements of the study included testing a novel approach to optimize community engagement that uses real-time data to inform intervention adaptation and implementation, using advances in social computing and machine learning to better understand patterns of misinformation in social media, and using multilevel social network analysis techniques to increase intervention agility, intensity, and reach. This project had three aims: Aim 1: Expand existing sources of population-based COVID-19 surveillance data to quantify infection, testing and vaccination trends in three Texas regions, and use innovative methods to inform and evaluate the proposed interventions. Aim 2: Adapt and implement the adapted multilevel community just-in-time adaptive intervention (MC-JITAI) to increase SARS-CoV-2 testing, mitigation behaviors, and COVID-19 vaccination, among underserved and vulnerable populations in three regions of Texas and conduct; informed by 1) previously collected data (from Phase II), 2) misinformation monitoring studies, and 3) social network information to improve SARS-CoV-2 testing. Aim 3: Evaluate the adapted (in Aim 2) multilevel community intervention (MC-JITAI) and determine how enhancements based on social networks improves SARS-CoV-2 testing and COVID-19 vaccination, in three regions of Texas. Data shared came from Aim 3 where the intervention was evaluated and were baseline measures of the intervention arm.

Principal Investigator: Maria Eulalia Fernandez, PHD

Has Data Files: No

Study Domain: Disease Surveillance; Social Determinants of Health; Community Outreach Programs

Data Collection Method: Survey

Keywords: Existing (Legacy)

Study Design: Interventional/Clinical Trial

Multi-Center Study: Yes

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

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

Data Types, Other: N/A

Study Start Date: 12/01/2022

Study End Date: 11/30/2024

Species: Human Data

Estimated Cohort Size: 525

Study Population Focus: Hispanic and Latino; Older Adults or Elderly; Adults; Underserved/Vulnerable Population; Rural Communities; African American

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

Acknowledgement Statement: This study was supported through funding, 3U01MD018308-01S1, 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 underserved communities. Approved users should acknowledge the provision of data access by dbGaP for accession phs003687.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-22-006

NIH Grant or Contract Number(s): 3U01TR004355-01S1

Consent/Data Use Limitations: General Research Use