University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials Unit

描述(由申请人提供)：夸祖鲁-纳塔尔大学南非艾滋病研究计划中心(CAPRISA)艾滋病毒/艾滋病临床试验股(CTU)汇集了来自HPTN、MTN和IMPAACT领导层的三名高级调查人员，领导一个独特的南非CTU，由五个伙伴机构组成的联盟，在五个研究优先领域进行研究。为了实现这一目标，CTU包括六个久负盛名的临床试验地点，这些地点在能够招募和保留大量预防和治疗试验队列方面有着良好的记录。以农村社区为基础的CAPRISA Vulindlela站点将进行疫苗、杀微生物剂和预防试验，该站点的青少年和年轻妇女队列中艾滋病毒流行率为42.7%，发病率为每100人年8.5例(年保留率：95.0%)。为金矿及其社区服务的Aurum-CAPRISA网站将进行疫苗和临床管理优化试验，黄金矿工的艾滋病毒感染率为32.1%，艾滋病毒发病率为每100人年4.1例(年保留率：95.1%)。位于该国最大的结核病诊所之一的CAPRISA-Thekwini网站将进行临床管理试验的优化，该诊所去年治疗了8580名新结核病患者，艾滋病毒感染率为64.6%，抗逆转录病毒治疗依从性为95.2%。位于德班的Doris Duke医学研究所的Umbilo站点非常适合进行临床强化的I期试验，也有一个性工作者队列，艾滋病毒流行率为57.9%，疫苗和杀微生物剂试验的发病率为每100妇女年9.8例(年保留率：98%)。位于德班1,200个床位的Umlazi医院每年管理约12,000次分娩，艾滋病毒感染率为50.7%，9个月时母婴传播率为20%。位于德班初级卫生诊所的Cato Manor站点每年管理1320例怀孕，艾滋病毒流行率为48.1%，9个月母婴传播率为18%。这两个地点都将进行母婴传播试验。反恐股行政部门有11个专门知识核心(药剂学、数据管理、统计学、实验室、行为、卫生经济学、生物伦理、社区参与、质量保证、监管和培训)，将支持现场一级的活动，并酌情集中某些职能。一名经验丰富的全职业务主任将协调各核心向每个地点提供的支助，并将确保有效的系统，以监测每个地点试行工作的质量。各地点与反恐股行政部门之间的有效沟通和对反恐股业绩的集体监测是通过反恐股执行委员会每月举行的会议进行的，执行委员会由主计长、协理主管、业务主任、行政经理和现场领导组成。此外，每个地点都有一个社区咨询委员会，由反恐联盟社区咨询委员会的代表组成。这个CTU包括在HIVNET、HPTN、HVTN和CIPRA领域的科学领导地位的跟踪记录，随时可以接触到艾滋病毒高风险的大型队列，在核心和地点由经验丰富的人员建立的临床试验基础设施，与Fogarty艾滋病培训相结合的培训计划，以及与Five Network的科学议程很好地一致的潜在科学贡献。 管理组件：

DESCRIPTION (provided by applicant): The University of KwaZulu-Natal - Centre for the AIDS Programme of Research in South Africa (CAPRISA) HIV/AIDS Clinical Trials Unit (CTU) brings together three senior investigators from the leadership of the HPTN, MTN and IMPAACT to lead a uniquely South African CTU, comprising a consortium of five partner institutions conducting research in five research priority areas. To achieve this, the CTU includes six well-established clinical trials sites which have a track record for being able to recruit and retain large cohorts for prevention and treatment trials. The rural community based CAPRISA Vulindlela Site, with HIV prevalence of 42.7% and incidence of 8.5 per 100 person-years in cohorts of adolescent and young women (annual retention rate: 95.0%) will conduct vaccine, microbicide and prevention trials. The Aurum - CAPRISA Site, which serves gold miners and their communities, has HIV prevalence of 32.1% and HIV incidence of 4.1 per 100 person-years in gold miners (annual retention rate: 95.1%) will conduct vaccine and clinical management optimization trials. The CAPRISA - Thekwini Site at one the country's largest TB clinics, which treated 8580 new TB patients last year with HIV prevalence of 64.6% and ART adherence of 95.2%, will conduct optimization of clinical management trials. The Umbilo Site at the Doris Duke Medical Research Institute in Durban, which is well suited to conduct clinically intensive phase I trials, also has a sex worker cohort with 57.9% HIV prevalence and an incidence rate of 9.8 per 100 women-years (annual retention rate: 98%) for vaccine and microbicide trials. The Umlazi Site at a 1,200 bed Durban hospital manages about 12,000 deliveries annually with HIV prevalence of 50.7% and MTCT rate of 20% at 9 months and the Cato Manor Site at a Durban primary health clinic, manages 1320 pregnancies annually with HIV prevalence of 48.1% and MTCT rate of 18% at 9 months will both conduct pMTCT trials. The CTU administrative component has eleven cores of expertise (pharmacy, data management, statistics, laboratory, behavioral, health economics, bioethics, community involvement, quality assurance, regulatory and training) which will support site level activities and centralize certain functions, where appropriate. An experienced full-time Operations Director will coordinate support provided by the cores to each site and will ensure effective systems for monitoring the quality of trial implementation at each site. Effective communication between sites and the CTU administrative component and collective monitoring of CTU performance occurs through the monthly meetings of the CTU Executive Committee comprising the PI, co-PIs, Operations Director, Administrative Manager and the Site Leaders. Further, each site has a community advisory committee with representatives on the CTU Community Advisory Board. This CTU encompasses a track record of scientific leadership in HIVNET, HPTN, HVTN, and CIPRA, ready access to large cohorts at high HIV risk, established clinical trial infrastructure with experienced personnel in the cores and sites, a training programme integrated with Fogarty AIDS training, and potential scientific contributions well aligned with the scientific agendas of five Networks. ADMINISTRATIVE COMPONENT: