Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU) Administrative Supplement (06/01/20-11/30/20) PROJECT SUMMARY The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); and adult HIV therapeutic strategies including HIV cure, management of non- infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU is comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women’s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly collaborative entity, which has centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions are driven by a rigorous evaluation process based on established metrics of performance and robust communication among leadership and staff of the CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory (CRL), a Research Pharmacy Coordinator (RPC), Data and Quality Management Plans, and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS, hepatitis C virus infection, and tuberculosis, and have well-grounded connections with the communities in which they are based. The CTU is well poised and experienced to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the conduct of studies which cross traditional network boundaries and that enables rapid responses to new scientific directions as they emerge. Under this Administrative Supplement application, The HBP CTU is responding to NIAID’s Notice of Special Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase underst...