Vanderbilt CTU SARS-CoV-2 Supplement

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Project Summary Coronavirus disease 2019 (COVID-19) pandemic caused by Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) required a rapid, coordinated response. The pandemic has interfered with many other important endeavors, including NIH-sponsored non-COVID HIV clinical trials. We need robust plans to implement measures to expand SARS-CoV-2, allowing research units to resume studies being conducted on HIV, while maintaining the safety and well-being of participants and staff. To this end, we have developed strategies relying on a combination of testing for active disease, evaluating seroprevalence, and conducting operations in ways that enforce social distancing and utilization of personal protective equipment (PPE). This project is being implemented at the Vanderbilt Therapeutics Clinical Research Site (VT-CRS), and the Washington University Prevention & Therapeutics (WPT) CRS. This strategy will comprise two aims that involve research participants, their household contacts, and staff: Aim 1) To utilize resources obtained through this administrative supplement to expand SARS-CoV-2 testing within the regions of our Clinical Research Sites; and Aim 2) To utilize resources obtained through this administrative supplement to more quickly and fully resume on-site research activities at our Clinical Research Sites. Among the activities to be implemented are universal testing of study participants for infection by SARS-CoV-2 PCR prior to study visits, either by staff during parking lot drive-through visits or self- collected remotely by study participants. At one CRS, testing will also be offered to adult household contacts of study participants. There will be active screening for symptoms of COVID-19. There will be SARS-CoV-2 antibody testing at the beginning and end of the project period, of staff and/or study participants. This project will substantially expanding SARS-CoV-2 testing, and expedite the opening of our NIAID-funded CRSs. In addition, the experience and information gained during this project will inform future strategies to further expand testing and facilitate clinical trials operations.