Weill Cornell Medical College-New Jersey Medical School Clinical Trials Unit

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DESCRIPTION (provided by applicant): The Weill Cornell Medical College - New Jersey Medical School Clinical Trials Unit (WCMC-NJMS CTU) will conduct National Institute of Allergy and Infectious Diseases (NIAID)-sponsored network studies of HIV treatment and HIV prevention and enroll participants from communities of the New York City (NYC)-Newark metropolitan area, the epicenter of HIV in the U.S. The unit consists of a central core and three clinical research sites (CRS). The WCMC-NJMS CTU provides central research support to the three CRS, including investigative oversight; financial administration; coordination of laboratories, pharmacy, regulatory assurance, data management, quality assurance, training; and community engagement. The three CRS, WCMC-Uptown, WCMC-Chelsea, and NJMS-Newark are located in different parts of the NYC-Newark metropolitan area and serve distinct, racially and ethnically diverse patient populations of HIV-infected and at-risk individuals. WCMC-Uptown CRS is located close to Harlem, a neighborhood with an HIV seroprevalence rate of nearly 3%. The WCMC-Chelsea CRS is located in Chelsea, the neighborhood with the highest HIV seroprevalence rate in NYC of over 4%. The NJMS-Newark CRS is located in the center of Newark, and serves a predominately African American population with a seroprevalence of 3%. WCMCNJMS CTU investigators are leaders in the field who are shaping the HIV treatment and HIV prevention research agendas. They are highly experienced with expertise in non-infectious complications of HIV; HCV studies of both mono- and co-infected individuals; tuberculosis, including cutting-edge diagnostics; HIV related malignancies; novel antiretrovirals; and HIV prevention, including studies of pre-exposure prophylaxis (PrEP) to prevent HIV acquisition. Community engagement is a key strength of the WCMC-NJMS CTU with both site-specific and joint Community Advisory Boards (CAB), and a strong record of effectively communicating study results back to the community. In summary, the WCMC-NJMS CTU brings together a diverse group of recognized investigator leaders who will work with an experienced clinical research staff to conduct cutting-edge HIV treatment and HIV prevention studies in the NYC-Newark metropolitan area.