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

描述(由申请人提供)：威尔·康奈尔医学院-新泽西医学院临床试验中心(WCMC-NJMS CTU)将开展由国家过敏和传染病研究所(NIAID)赞助的艾滋病毒治疗和艾滋病毒预防网络研究，并从纽约市(NYC)-纽瓦克大都会地区的社区招募参与者，纽约-纽瓦克都会区是美国艾滋病毒的中心。该单位由一个中心核心和三个临床研究站点(CRS)组成。WCMC-NJMS CTU为三个CRS提供中央研究支持，包括调查监督、财务管理、实验室协调、药房、监管保证、数据管理、质量保证、培训和社区参与。WCMC-Uptown、WCMC-切尔西和NJMS-Newark三家CRS分别位于纽约市-纽瓦克大都市区的不同地区，为不同种族和民族的艾滋病毒感染者和高危人群提供服务。WCMC-Uptown CRS位于哈莱姆附近，哈莱姆是一个艾滋病毒血清阳性率接近3%的社区。WCMC-切尔西CRS位于切尔西，这是纽约市艾滋病毒血清阳性率最高的社区，超过4%。NJMS-Newark CRS位于纽瓦克市中心，主要服务于非洲裔美国人，血清阳性率为3%。WCMCNJMS CTU调查人员是该领域的领导者，他们正在制定艾滋病毒治疗和预防研究议程。他们在以下领域拥有丰富的经验：艾滋病毒的非传染性并发症；单一感染者和联合感染者的丙型肝炎病毒研究；结核病，包括尖端诊断；艾滋病毒相关的恶性肿瘤；新型抗逆转录病毒药物；以及艾滋病毒预防，包括预防艾滋病毒感染的暴露前预防(PrEP)研究。社区参与是WCMC-NJMS CTU的一个关键优势，它拥有特定地点和联合社区咨询委员会(CAB)，并在有效地将研究结果反馈给社区方面有着良好的记录。总之，WCMC-NJMS CTU汇集了一群公认的研究人员领导人，他们将与经验丰富的临床研究人员合作，在纽约市-纽瓦克大都市区进行尖端的艾滋病毒治疗和艾滋病毒预防研究。

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.