dbGaP Study Accession: phs002763

NIH Institute/Center: NIEHS

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/77xd-fh20

Study Description: This project employed sentinel and community-based epidemiological surveillance and participatory research methods to evaluate whether a person-centered, rapid COVID-19 testing intervention (at-home swab and send, or on-site point of care testing), coupled with a novel mHealth COVID-19 Literacy and Outreach Suite of apps and videos, would serve to increase the acceptance, access, reach, uptake, and impact of COVID-19 testing at UI Health and in the 14 FQHC practice sites and their corresponding catchment areas. The social, ethical, economic, and behavioral drivers and consequences of this outreach and testing approaches were evaluated according to the degree to which participants contributed to the co-creation of study-related messaging. The study leveraged existing infrastructures to expand testing uptake and analyzed (by PCR) viral load at infection onset/exposure and following onset/exposure to determine viral dynamics and identify individuals at early and late stages of infection. NIH PhenX self-report measures were used to test intervention effects on testing and retesting uptake, time-to-diagnosis, COVID-19 knowledge, healthcare access and seeking, disclosure, medical adherence, and practice of home self-isolation, quarantine, and other infection control behaviors. All data acquisition, collection and curation approaches were informed by the CDCC, including AboutML-informed consent approaches and with the other RADx-UP studies and relevant federal agencies. The central hypothesis of this study argued that a persuasive mHealth Suite of apps and videos (co-created with community members) combined with person-centered COVID-19 testing choices (remote at home nasal swab versus on-site nasal swab), will lead to higher COVID-19 testing uptake in 7000 adults and children living in the geographic catchment areas of the 14 Mile Square Health Center practice sites (as compared with baseline rates of testing uptake in the same geographic catchment area). This relationship was mediated by a number of social, economic, and behavioral determinants of health, including self-reported COVID-19-related knowledge, COVID-19 social capital, COVID-19 racial/ethnic bias and stigma, and COVID-19 preventative and risk behaviors. Analysis of mediators was limited to the adult sample. This was accomplished utilizing a repeated measure, pre-post-test mediational design. Interviews were conducted over the phone on Day 1 and Day 28 of a 28-day study period, to track outcomes. With improved access to testing and care, self-management strategies of COVID-19 and increased knowledge, a higher percentage of people living in underserved neighborhoods will have access to testing and necessary follow-up care and are expected to develop a stronger sense of empowerment over their own healthcare decisions related to COVID-19. Three groups were recruited to participate in this study. The first group was recruited from the 14 Mile Square Health Center (MSHC) practice sites. The second group was recruited through contact tracing of COVID-19 test positives from MSHC. The third group was recruited from the community through posted study ads and flyers online, which first contained the study contact number and eventually contained an invitation to find out about the study through the mobile health (mHealth) suite of apps and videos. In addition to nasal swab testing for COVID-19, participants had access to smartphone apps to track symptoms, improve knowledge of COVID-19, and learn self-management skills while at home. Participants who were not initially identified via a call or in-person visit to Mile Square Health Clinic were given the opportunity to partake in rapid, COVID-19 nasal swab self-collection at home. Research members shared the data collected from the biological specimens, interviews, and apps with the Illinois Department of Public Health. The final goal of this study was the prevention of COVID-19 transmission through increased COVID-19 literacy and empowerment, combined with early intervention via rapid diagnosis, contact tracing, and earlier access to treatment.

Updated Date: 04/17/2024

Principal Investigator: Ismail, Nahed

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Digital Health Applications; Point-of-Care (POC) Testing; Rapid Diagnostic Test (RDT); Social Determinants of Health; Testing Rate or Uptake

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

Keywords: COVID Education; Health Literacy; Individual-Level Data; Near Patient Testing; Viral Dynamics; mHealth

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Electronic Medical Records; Family History; Genomic; Questionnaire or Survey; Social

Study Start Date: 11/11/2020

Study End Date: 07/31/2022

Species: Human

Estimated Cohort Size: 7000

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

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8674011/

Acknowledgement Statement: This study was supported through funding, 3R01ES028615-07S2, for the National Institute of Environmental Health Sciences (NIEHS) as part of the RADx-UP program. The study PIs would like to acknowledge Ms. Keiana Watkins, MSPH, The Clinical Trials Project Leader I, as well as Ms. Elizabeth Chege, the Engagement Impact Team- Associate Project Leader, Coordination and Data Collection Center for RADx-UP (Rapid Acceleration of Diagnostics Underserved Populations), Duke Clinical Research Institute (DCRI) for their valuable help, advise, and support throughout this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002763.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): 3R01ES028615-07S2

Consent/Data Use Limitations: General Research Use