Centers for Innovative Research to Control AIDS

描述（由申请人提供）：我们建议成立“控制艾滋病创新研究中心”（CIRCA）作为临床试验单位（CTU），致力于开展艾滋病毒预防试验提出的研究；网络（HPTN）和杀微生物剂试验网络（MTN）。CIRCA将在位于纽约市（NYC）和新泽西州纽瓦克的五个临床研究点（CRS）进行这些研究，这两个社区是美国受艾滋病流行影响最严重的两个社区。CIRCA将专注于在美国HIV感染风险最高的人群进行研究，这些人群传统上在临床试验中代表性不足，包括非洲裔美国人、西班牙裔美国人、妇女和药物使用者。CIRCA是由哥伦比亚大学梅尔曼公共卫生学院管理的一个联合体，拥有五个crs。哈莱姆艾滋病预防中心和新泽西医学与牙科大学（UMDNJ）站点将参与HPTN和MTN研究，两个纽约血液中心站点将参与HPTN研究，布朗克斯-黎巴嫩医院中心站点将参与MTN研究。在过去的五年里，纽约市的四个CRSs一起成功地开展了HPTN赞助的预防和杀微生物剂研究。在这一应用中，他们正在与联合国艾滋病规划署网站合作，该网站在预防方面拥有丰富的经验，并致力于为同样面临艾滋病毒感染风险的人群提供服务。中国保监会的调查人员带来了丰富的专业知识，这些专业知识跨越了推进HPTN和MTN科学议程所需的学科。他们领导并参与了多中心研究，是科学工作组和协议团队的关键参与者，具有实地实践经验，开发了创新的行为和生物医学干预措施，并利用创造性方法评估干预措施的影响。最重要的是，调查人员获得了社区的信任。他们建立了在被剥夺权利的社区进行道德研究的框架。他们成立了一个充满活力的社区咨询委员会，确保社区教育和参与。中国CIRCA是一个有凝聚力的单位，拥有高效的组织计划，有效的招聘和保留计划，严格的质量保证体系和细致的数据收集和管理流程。不幸的是，美国艾滋病疫情的严重程度被低估了。每年有4万多例新的艾滋病毒感染，主要发生在CIRCA所在的社区。CIRCA工作人员和调查人员的互补技能和经验，以及他们对社区的共同承诺，将使他们能够为发现新的策略做出贡献，以防止艾滋病毒在美国和世界各地进一步传播。

DESCRIPTION (provided by applicant): We propose the formation of the "Centers for Innovative Research to Control AIDS" (CIRCA) as a clinical trials unit (CTU) devoted to the conduct of research proposed by the HIV Prevention Trials; Network (HPTN) and the Microbicide Trials Network (MTN). CIRCA will conduct these studies at five clinical research sites (CRS) located in New York City (NYC) and Newark, New Jersey-two of the communities most severely affected by the HIV epidemic in the US. CIRCA will focus on conducting studies with populations that are at the highest risk for HIV infection in the U.S. and that have traditionally been underrepresented in clinical trials including African Americans, Hispanics, women and substance users. CIRCA is a consortium administratively situated at the Mailman School of Public Health at Columbia University with five CRSs. The Harlem HIV Prevention Center and the University of Medicine & Dentistry of New Jersey (UMDNJ) site will participate in both HPTN and MTN studies, the two New York Blood Center sites will participate in HPTN studies and the Bronx-Lebanon Hospital Center site will participate in MTN studies. Tie four CRSs in NYC have worked together for the past five years successfully conducting HPTN sponsored prevention and Microbicide studies. They are partnering in this application with the UMDNJ site, a site with extensive experience in prevention and with a commitment to the same populations at risk for HIV. The CIRC^ investigators bring a wealth of expertise that spans the disciplines required to advance the scientific agendas of the HPTN and MTN. They have led and participated in multi-center research, have been key participants in scientific working groups and protocol teams, have practical field experience, have developed innovative behavioral and biomedical interventions and have utilized creative methods to evaluate the impact of the interventions. Most importantly, the investigators have gained the trust of their communities. They have established the framework for the ethical conduct of research in disenfranchised communities. They have formed a vigorous and vibrant community advisory board to ensure community education and involvement. CIRCA is a cohesive unit with an efficient organizational plan, effective recruitment and retention plans, a rigorous quality assurance system and a meticulous process for data collection and management. Unfortunately, the magnitude of the HIV epidemic in the US is underestimated. More than 40,000 new HIV infections occur every year, primarily in those very communities where CIRCA sites are situated. The complementary skills and experiences of the CIRCA staff and investigators as well as their shared commitment to their communities will enable them to contribute to the discovery of new strategies to prevent the further spread of HIV in the US and around the world. ADMINISTRATIVE COMPONENT: