Columbia Collaborative HIV/AIDS Clinical Trials Unit

描述（由申请人提供）：本申请的总体目标是建立哥伦比亚合作HIV/AIDS临床试验单位（CC-CTU）。本申请汇集了哥伦比亚大学医学中心（CDC）、纽约血液中心（NYBC）和哈莱姆医院的哈莱姆家庭中心（HFC）的研究者，以实现以下具体目标：（1）建立一个临床试验单位，以支持艾滋病临床试验小组的科学议程，艾滋病毒疫苗试验网络（HVTN）和国际母婴青少年艾滋病临床试验（IMPAACT）小组;（2）积极为附属网络的科学和领导力做出贡献（ACTG，HVTN，IMPAACT）通过科学和资源委员会和协议团队的成员资格;（3）在多中心HIV临床试验的背景下指导和培养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、文化上适当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。为实现这些目标，将召集一组具有艾滋病司（DAIDS）赞助的网络临床研究经验的研究人员，组成一个综合临床试验单位，为纽约市艾滋病毒疾病负担沉重或有感染艾滋病毒风险的人群提供治疗性和预防性疫苗临床试验机会。CC-CTU的行政中心将设在CNOC（S。Hammer，PI），并将由以下五个临床研究中心（CRS）组成：艾滋病毒预防和治疗CRS在CNOC（S。哈默，PI），将参加ACTG和HVTN试验;哈莱姆家庭中心CRS（VV。埃尔萨德尔，PI），这将参加ACTG试验; NYBC布朗克斯和NYBC联合广场CRS的（B。Koblin，PI），其将参与HVTN试验;以及IMPAACT CRS，其将在CNOC进行（P. LaRussa，PI）。强有力的社区伙伴关系将是CC-CTU成功的关键，一个深入的社区教育和外展计划已经到位。两个坚定的CAB，一个专注于治疗，一个专注于预防，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社区。在CTU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护理和公共卫生改善的有效模式。 行政部门：

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: