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

描述（申请人提供）：威尔康奈尔医学院-新泽西医学院临床试验部门（WCMC-NJMS CTU）将进行国家过敏和传染病研究所（NIAID）赞助的艾滋病毒治疗和预防网络研究，并招募来自纽约市（NYC）-纽瓦克大都市区社区的参与者，该单位由一个中心核心和三个临床研究中心（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。三个CRS，WCMC-Uptown，WCMC-Chelsea和NJMS-Newark位于NYC-Newark大都市区的不同部分，为不同的，种族和种族多样化的艾滋病毒感染者和高危人群提供服务。WCMC住宅区CRS靠近哈莱姆，这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，纽约市艾滋病毒血清阳性率最高的社区，超过4%。NJMS-纽瓦克CRS位于纽瓦克市中心，主要服务于血清阳性率为3%的非裔美国人人群。WCMCNJMS CTU研究人员是该领域的领导者，他们正在制定艾滋病毒治疗和艾滋病毒预防研究议程。他们在艾滋病毒的非感染性并发症方面具有丰富的经验;单感染和合并感染个体的HCV研究;结核病，包括尖端诊断;艾滋病毒相关恶性肿瘤;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，该CTU拥有特定地点和联合社区咨询委员会（CAB），以及将研究结果有效传达给社区的良好记录。总而言之，WCMC-NJMS CTU汇集了一群公认的研究者领导者，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.