Vanderbilt CTU SARS-CoV-2 Supplement

Project SummaryCoronavirus disease 2019 (COVID-19) pandemic caused by Severe Acute Respiratory Syndrome coronavirus2 (SARS CoV-2) required a rapid, coordinated response. The pandemic has interfered with many other importantendeavors, including NIH-sponsored non-COVID HIV clinical trials. We need robust plans to implementmeasures to expand SARS CoV-2, allowing research units to resume studies being conducted on HIV, whilemaintaining the safety and well-being of participants and staff. To this end, we have developed strategies relyingon a combination of testing for active disease, evaluating seroprevalence, and conducting operations in waysthat enforce social distancing and utilization of personal protective equipment (PPE). This project is beingimplemented at the Vanderbilt Therapeutics Clinical Research Site (VT-CRS), and the Washington UniversityPrevention & 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 supplementto expand SARS-CoV-2 testing within the regions of our Clinical Research Sites; and Aim 2) To utilize resourcesobtained through this administrative supplement to more quickly and fully resume on-site research activities atour Clinical Research Sites. Among the activities to be implemented are universal testing of study participantsfor infection by 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 ofstudy participants. There will be active screening for symptoms of COVID-19. There will be CoV-2 antibodytesting at the beginning and end of the project period, of staff and/or study participants. This project willsubstantially expanding CoV-2 testing, and expedite the opening of our NIAID-funded CRSs. In addition, theexperience and information gained during this project will inform future strategies to further expand testing andfacilitate clinical trials operations.