dbGaP Study Accession: phs003484

NIH Institute/Center: NIMHD

RADx Data Program: RADx-UP

Release Date: 03/04/2024

DOI: 10.60773/ewfr-hd70

Study Description: Black communities in the U.S. have disproportionately experienced adverse outcomes attributable to the COVID-19 pandemic. While COVID-19 cases and deaths have declined in recent months, emergent variants continue to pose threats to the health of Black communities and others. COVID-19 testing has recently shifted from primarily point-of-care testing to widespread use of rapid home antigen tests. Home testing may be preferable to clinic-based testing for Black persons, many of whom have a high degree of well-founded, historically based mistrust of the medical system, but very little is currently known about knowledge, attitudes, and behaviors surrounding COVID-19 home testing among Black people. In addition to challenges related to affordability and accessibility of home testing, the privacy afforded by home testing comes at the expense of surveillance information. Home tests are rarely reported to public health surveillance, and specimens are unavailable for genetic sequencing and variant detection. This results in a substantial gap in public health knowledge about COVID-19 burden of disease and circulating variants, which may be particularly problematic for Black communities with higher risk for adverse outcomes. This project was a pre-post intervention study based in Black communities in Atlanta, GA to assess willingness of research participants to use a COVID-19 rapid home test and to simultaneously mail a self-collected anterior nares sample to a commercial laboratory for confirmatory PCR testing. The project provided culturally competent oral and illustrated written communication messages encouraging continued COVID-19 vigilance and home testing alongside self-collection of a specimen for mail-off testing. These messages were packaged with a home test kit for rapid testing and self collecting and mailing a second specimen to a laboratory. If a subset of home testers were willing to self-collect and mail a specimen for confirmatory testing, multiplier methods were used to estimate burden of disease and circulating variants among home testers. However, people with medical mistrust might not have elected to share biological specimens for surveillance purposes. The study aimed to understand motivations and barriers for using this type of testing modality in Black communities while also assessing general knowledge, attitudes, and behaviors related to home testing. Specific aims were: (1) Develop culturally appropriate, empowering communications strategies underscoring the importance of home COVID-19 testing for individual and public health; (2) Assess knowledge, attitudes, and behaviors regarding COVID-19 rapid home testing among sociodemographically diverse Black communities; (3) Assess willingness to provide, in conjunction with a rapid home test, a self-collected specimen to a laboratory for confirmatory COVID-19 testing; (4) Conduct in-depth interviews with persons completing (N=10) and not completing (N=10) the study-provided home test to further improve communications strategies using participants' open-ended reflections on intervention effectiveness.

Updated Date: 03/04/2024

Principal Investigator: Bradley, Heather

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Pandemic Perceptions or Decision-Making; Rapid Diagnostic Test (RDT); Social Determinants of Health; Testing Rate or Uptake; Virological Testing

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

Keywords: Burden of Illness; Individual-Level Data

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Behavioral; Questionnaire or Survey; Social

Study Start Date: 11/01/2022

Study End Date: 10/31/2024

Species: Human

Estimated Cohort Size: 800

Study Population Focus: Adults; African Americans; Older Adults or Elderly; Racial or Ethnic Minorities

Acknowledgement Statement: This study was supported through funding, 3U01MD018313-01S1, for the National Institute on Minority Health and Health Disparities (NIMHD) as part of the RADx-UP program. Project investigators would like to express gratitude to the research staff and graduate research assistants at Emory Rollins School of Public Health and Georgia State University, and to our study participants, without whom this research would not have been possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs003484.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-22-005

NIH Grant or Contract Number(s): 3U01MD018313-01S1

Consent/Data Use Limitations: General Research Use