dbGaP Study Accession: phs002760

NIH Institute/Center: NHLBI

RADx Data Program: RADx-UP

Release Date: 08/30/2023

DOI: 10.60773/c9fp-qk33

Study Description: COVID-19, the disease caused by SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), led to a global pandemic and exacerbated existing health inequities among vulnerable populations. Despite higher rates of COVID-19 in Black and Latinx individuals compared to White individuals, rates of testing in predominately non-White, low-income communities were significantly lower than in high-income areas. Strategies to increase COVID-19 testing rates in underserved populations were urgently needed. Self-testing, where individuals collect their own samples, was feasible for the detection of SARS-CoV-2. Self-testing increased testing convenience and privacy and was effectively leveraged to expand testing for other infections, such as HIV, in key populations across a broad spectrum of contexts. However, self-testing may be limited to those with access to health services, without reaching individuals underserved by existing medical systems. One promising approach to increase test uptake was the secondary distribution of self-testing kits, where an individual distributes tests to contacts in their social network and encourages them to self-test. A significant advantage of a secondary distribution strategy was that by decentralizing a health care process, individuals were more likely to access services if delivered by social network peers, rather than health professionals. In addition, secondary distribution enhanced contact tracing efforts, as individuals diagnosed with COVID-19 could have distributed self-tests to close contacts to identify additional cases. Given high levels of COVID-19 misinformation, stigma, and medical mistrust among vulnerable populations, this peer-driven test distribution strategy holds significant promise in increasing the reach of COVID-19 testing among underserved populations. In collaboration with the community-based partner, Public Health Management Corporation, the study conducted a 1:1 randomized trial with 1048 individuals cared for at Federally Qualified Health Centers to evaluate whether secondary distribution of SARS-CoV-2 self-tests increases test uptake compared with referrals among underserved populations in Philadelphia (Aim 1). The study will assess whether the secondary distribution of self-tests to close contacts among individuals with COVID-19 facilitates case detection (Aim 2). Additionally, the study will use a mixed methods strategy to identify key social, ethical, economic, and behavioral barriers and facilitators to secondary distribution to inform its future modifications, implementation, and scale-up (Aim 3). This study will engage in the relationship with community partners to reach underserved individuals with housing instability, immigrants, and those with significant medical comorbidities including HIV, viral hepatitis, and substance use disorders, in order to increase COVID-19 test uptake in these populations. As more rapid and user-friendly diagnostic tests emerged, this secondary distribution model may have become even more impactful. The project may establish a new paradigm for expanding COVID-19 testing and contact tracing.

Updated Date: 04/17/2024

Principal Investigator: Gross, Robert

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Community Outreach Programs; Comorbidities; Substance Use; Testing Rate or Uptake

Data Collection Method: Antigen Testing Device; Interview or Focus Group; Survey

Keywords: Comorbid Populations; HIV; Viral Hepatitis

Study Design: Interventional or Clinical Trial

Multi-Center Study: No

Data Types: Behavioral; Clinical; Questionnaire or Survey; Social

Study Start Date: 11/01/2020

Study End Date: 10/31/2022

Species: Human

Estimated Cohort Size: 1000

Study Population Focus: Adults; African Americans; Asians; Hispanics or Latinos; Homeless or Unhoused Populations; Immigrants; Lower Socioeconomic Status (SES) Populations; Older Adults or Elderly; People Living with HIV/AIDS; Racial or Ethnic Minorities

Publication URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7818126/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8486581/; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9630136/

Acknowledgement Statement: This study was supported through funding, 3R01HL151292-03S1, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx-UP program. The study is described in detail in: Bien-Gund C, Shah J, Ho J, Shea K, Dugosh K, Gross R. The COVID-19 Self-Testing through Rapid Network Distribution (C-STRAND) trial: A randomized controlled trial to increase COVID-19 testing in underserved populations  Contemporary Clinical Trials 2021 The project acknowledges the efforts of Cedric Bien-Gund MD, Kathleen Shea, Karen Dugosh PhD, Owen, Melanie, and the staff of the Philadelphia Health Management Corporation clinical sites, the Community Advisory Board, the Data and Safety Monitoring Board and the study participants. Approved users should acknowledge the provision of data access by dbGaP for accession phs002760.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-19-056

NIH Grant or Contract Number(s): 3R01HL151292-03S1

Consent/Data Use Limitations: General Research Use