Columbia Collaborative HIV/AIDS Clinical Trials Unit

哥伦比亚艾滋病毒/艾滋病临床试验合作单位

• 批准号: 8197559
• 负责人: Scott M Hammer
• 金额: $ 264.46万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8197559
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Academic Medical Centers; Acquired Immunodeficiency Syndrome; Blood; Caring; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Commit; Communities; Community Health Education; Community Outreach; Community Relations; Disease; Face; Family; Goals; HIV; HIV Vaccine Trials Network; Hospitals; Individual; International Maternal Pediatric Adolescent AIDS Clinical Trials; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Leadership; Mentors; Modeling; New York; New York City; Population; Prevention; Prevention Research; Preventive; Protocols documentation; Public Health; Research Personnel; Resources; Risk; Science; Therapeutic; Therapeutic Human Experimentation; Translations; Ursidae Family; Vaccine Clinical Trial; Work; clinical research site; experience; meetings; outreach; outreach program; programs; success

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:

描述（由申请人提供）：本申请的总体目标是建立哥伦比亚大学合作HIV/AIDS临床试验单位（CC-CTU）。这项申请汇集了哥伦比亚大学医学中心（CUMC）、纽约血液中心（NYBC）和哈莱姆医院哈莱姆家庭中心（HFC）的研究人员，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（ACTG）、艾滋病毒疫苗试验网络（HVTN）和国际孕产妇儿科青少年艾滋病临床试验小组（IMPAACT）的科学议程；(2)通过加入科学和资源委员会和协议团队，积极为附属网络（ACTG、HVTN、IMPAACT）的科学和领导做出贡献；(3)在多中心HIV临床试验的背景下，指导和培养初级研究者成为临床研究人员；(4)通过全面的社区教育计划、文化适宜的外展活动和活跃的社区咨询委员会，维持并继续建立牢固的社区关系。为实现这些目标，将汇集一个具有艾滋病司赞助的网络广泛临床研究经验的研究人员小组，组成一个综合临床试验单位，向纽约市承受艾滋病毒疾病沉重负担或感染艾滋病毒风险的人口提供治疗性和预防性疫苗临床试验机会。CC-CTU将在行政上以中国中医药大学（S. Hammer， PI）为中心，由五个临床研究中心（CRS）组成：中国中医药大学（S. Hammer， PI）的艾滋病预防和治疗CRS将参与ACTG和HVTN试验；哈莱姆家庭中心萨德尔（El-Sadr， PI）将参加行动小组的试验；NYBC-Bronx和NYBC-Union Square的CRS （B. Koblin， PI）将参与HVTN试验；以及CUMC的impact CRS （P. LaRussa， PI）。强有力的社区伙伴关系将是CC-CTU成功的关键，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的工作人员合作，通过提供与个人面临的挑战相关的临床试验，为社区服务。将CTU一级的艾滋病毒预防和治疗研究结合起来，是将研究成果迅速转化为改善护理和公共卫生的有效模式。