Weill Cornell Medicine - Rutgers New Jersey Medical School Clinical Trials Unit

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PROJECT SUMMARY The Weill Cornell Medicine – Rutgers New Jersey Medical School Clinical Trials Unit (WCM-NJMS CTU) will conduct National Institute of Allergy and Infectious Diseases (NIAID)-sponsored network studies of HIV treatment and HIV prevention; enroll participants from the diverse communities of the New York City (NYC)- Newark metropolitan area, the epicenter of the HIV epidemic in the U.S. -- home to 14% of Americans living with HIV; and contribute to the networks' scientific agendas. The unit consists of a central core facility and three clinical research sites (CRS). The WCM-NJMS CTU provides central research support to the three CRSs, including investigative and laboratory oversight, financial administration, quality assurance, training, and community engagement. The three CRSs, WCM-Uptown, WCM-Chelsea, and Rutgers NJMS, are located in different parts of the NYC-Newark metropolitan area and serve distinct, racially and ethnically diverse populations of people living with or at-risk for HIV. The WCM-Uptown CRS is located close to Harlem, with some neighborhoods demonstrating HIV seroprevalence rates of over 5%. The WCM-Chelsea CRS is located in Chelsea, with some neighborhoods demonstrating the highest seroprevalence rate in NYC of over 8%. The Rutgers NJMS CRS is located in the center of Newark, serving a predominately African American population with a high proportion of women, with some neighborhoods demonstrating an HIV seroprevalence rate of over 5%. WCM-NJMS 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 HIV cure strategies, antiretroviral drugs and treatment strategies, tuberculosis, and HIV comordibidities, including hepatitis and neurologic complications as well as HIV prevention strategies, including HIV pre-exposure prophylaxis (PrEP) and integrated strategies. Community engagement is a key strength of the WCM-NJMS CTU with both site-specific and joint Community Advisory Boards (CABs) and a strong record of effectively communicating study results back to the community. The CTU's three CRSs have successfully enrolled over 1000 participants into a wide variety of HIV treatment and prevention trials during the current grant cycle with outstanding retention and data quality. Furthermore, CTU investigators have made substantive scientific and leadership contributions to the networks. In summary, the WCM-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 areas.