Our team is part of the NIH-funded Rapid Acceleration for Diagnostics (RADx) Tech Clinical Studies Core with Dr. Soni serving as co-PI of the core and study-PI of digital studies under the core. Research produced by our group and Clinical Studies Core has led to several important publications, which contributed to decision-making by federal agencies. Details of specific studies pioneered by our group are included below:
-
Self-Testing for Our Protection from COVID-19: STOP COVID-19 study seeks to understand how and why people perform SARS-CoV-2 testing and report their results to the public health department. Participants participate in this study for three months and receive home-delivery of rapid antigen and PCR-collection kits if they report to be at-risk for SARS-CoV-2 infection. We also collect wearable device data from participants to understand if signals from wearable devices can help detect onset of SARS-CoV-2 infection.
-
Say Yes! COVID-19 Test Michigan Impact Analysis: We evaluated the Say Yes! COVID-19 test program in the Washtenaw county of Michigan by closely collaborating with the CareEvolution, LLC, Washtenaw county health department, CDC, and the NIH. Investigation of this program revealed a robust impact of distributing rapid antigen tests at scale with incidence of SARS-CoV-2 in the intervention community.
-
Say Yes! COVID-19 Test Digital Assistant Analysis: We evaluated anonymized data from the SYCT! Digital Assistant to describe reporting behavior of participants for results of rapid-antigen tests to public health departments and its’ association with incentivization. We also demonstrated that ordering of rapid-antigen tests was equitable, especially if the ordering portal was made available over a prolonged time period.
-
Test Us At Home and Test Us At Home Daily: We performed a largescale study to evaluate performance of rapid antigen tests in comparison to PCR tests. The study was performed in collaboration with the NIH and FDA and led to an update in guidance from the FDA and CDC about how to use the rapid antigen tests.
-
Digital ITAP: We established a paradigm for rapid evaluation of over-the-counter SARS-CoV-2 antigen tests that can be compared against molecular comparator assays to generate data for FDA emergency use authorization.