Columbia Collaborative HIV/AIDS Clinical Trials Unit

描述(由申请者提供)：本申请的总体目标是建立哥伦比亚合作艾滋病毒/艾滋病临床试验单位(CC-CTU)。(3)在多中心艾滋病毒临床试验的背景下，指导和发展初级研究人员作为临床研究人员；以及(4)通过全面的社区教育计划、适合文化的外展活动和积极的社区咨询委员会，保持并继续建立牢固的社区关系。将参加ACTG试验的El-Sadr，PI)；将参加HVTN试验的NYBC-Bronx和NYBC-Union Square CRS(B.Koblin，PI)；以及CUMC的IMPAACT CRS(P.LaRussa，PI)。强有力的社区伙伴关系将是CC-CTU成功的关键，并已制定了深入的社区教育和外联计划。两家专注于治疗和预防的CAB将与CTU工作人员合作，通过提供与个人面临的挑战相关的临床试验来服务于社区。在反恐联盟一级整合艾滋病毒预防和治疗研究是将研究结果迅速转化为改善护理和公共卫生的有效模式。 管理组件：

DESCRIPTION (provided by applicant): The overall goal of this application is to establish the Columbia Collaborative HIV/AIDS Clinical Trials Unit (CC-CTU). This application brings together investigators at the Columbia University Medical Center (CUMC), the New York Blood Center (NYBC) and the Harlem Family Center (HFC) of Harlem Hospital to achieve the following specific aims: (1) establish a clinical trials unit in support of the scientific agendas of the AIDS Clinical Trials Group (ACTG), the HIV Vaccine Trials Network (HVTN) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group; (2) actively contribute to the science and leadership of the affiliated Networks (ACTG, HVTN, IMPAACT) through membership on scientific and resource committees and protocol teams; (3) mentor and develop junior investigators as clinical researchers within the context of multicenter HIV clinical trials; and (4) maintain and continue to build strong community relations through a comprehensive community education program, culturally appropriate outreach activities and active Community Advisory Boards. These aims will be met by bringing together a team of investigators with extensive Division of AIDS (DAIDS)-sponsored Network clinical research experience to form an integrated clinical trials unit which can provide therapeutic and preventive vaccine clinical trial opportunities to populations in New York City which bear a heavy burden of HIV disease or risk of HIV acquisition. The CC-CTU will be administratively centered at CUMC (S. Hammer, PI) and will be composed of five Clinical Research Sites (CRS's) as follows: the HIV Prevention and Treatment CRS at CUMC (S. Hammer, PI) which will participate in ACTG and HVTN trials; the Harlem Family Center CRS (VV. El-Sadr, PI) which will participate in ACTG trials; the NYBC-Bronx and NYBC-Union Square CRS's (B. Koblin, PI) which will participate in HVTN trials; and the IMPAACT CRS at CUMC (P. LaRussa, PI). Strong community partnerships will be key to the success of the CC-CTU and an in-depth community education and outreach program is in place. Two deeply committed CAB's, one focused on therapy and one focused on prevention, will work with the CTU staff to serve the community by offering clinical trials which are relevant to the challenges that individuals face. Integrating HIV prevention and therapeutic research at the CTU level is an effective model for the rapid translation of study results into improvements in care and public health. ADMINISTRATIVE COMPONENT: