Harvard/Boston/Providence Clinical Trials Unit (Harvard/B/P CTU)

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DESCRIPTION (provided by applicant): The Harvard/Boston/Providence Clinical Trial Unit (CTU) will be established to conduct clinical trials to address research areas of four NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); microbicidal HIV prevention strategies (MTN); 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 will be comprised of seven clinical research sites (CRSs) at institutions where the clinical trials will be conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Fenway Health Center, Boston Medical Center, and Miriam Hospital. The CTU will be led by three highly experienced PIs, Drs. Raphael Dolin, Kenneth Mayer, and Daniel Kuritzkes, and will include highly accomplished CRS leaders and collaborating investigators. The CTU will function as an integrated, highly collaborative entity, which will have centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions will be 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, a Research Pharmacy Coordinator, 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 to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure will facilitate the conduct of studies which cross traditional network boundaries and will enable rapid responses to new scientific directions as they emerge.