Philadelphia HIV Therapeutics and Prevention Clinical Trials Unit

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ABSTRACT The pandemic of COVID-19 has had and will continue to have a profound impact in the research operations of the Philadelphia CTU and its associated CRSs (Therapeutic and Prevention) The Aim of this supplemental request is to facilitate the return of safe and efficient clinical Research operations at the Philadelphia CTU, critically affected by the COVID-19 epidemic. We anticipate the following needs for our CTU from now until December 1st, 2020: 1. Personnel. We anticipate needs of at least one Clinical Research Coordinator in both the Therapeutic and the Prevention CRS. This need is necessitated to maintain the clinical staff required to implement COVID-19 related clinical activities while regular HIV-related trials resume; and in order to minimize risks to workers among our current staff who are at higher risk for severe illness from COVID-19 who will require limited time “in office” and face-to-face exposure to clinical trial participants. 2. Clinical supplies to ensure the safety of our employees and the clinical trial participants (Personal protective equipment, masks, gloves, face shields etc.). We are also anticipating that our institution will increase the requirement for COVID-19 testing of our personnel and our clinical trials participants. 3. Increased personnel in the laboratory to allow it to remain operational in the case that one of our employees needs to be quarantined or falls sick in the following months. 4. Equipment and testing kits for the clinical laboratory at the hospital of the University of Pennsylvania to ensure that the increased testing needs associated with our clinical research operations do not tax the regular clinical operations of the laboratory.