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-南非艾滋病研究项目中心（CAPRISA）艾滋病毒/艾滋病临床试验单位（CTU）汇集了来自HPTN， MTN和IMPAACT领导层的三位高级研究员，领导一个独特的南非CTU，由五个合作机构组成的财团在五个研究优先领域进行研究。为了实现这一目标，CTU包括6个完善的临床试验点，这些试验点有能力招募和留住大量人群进行预防和治疗试验。以农村社区为基础的CAPRISA Vulindlela站点，在青少年和年轻妇女队列中，艾滋病毒患病率为42.7%，发病率为每100人年8.5例（年保留率：95.0%），将进行疫苗、杀微生物剂和预防试验。Aurum - CAPRISA站点为金矿工人及其社区提供服务，金矿工人的艾滋病毒感染率为32.1%，艾滋病毒感染率为4.1 / 100人/年（年保留率：95.1%），将进行疫苗和临床管理优化试验。CAPRISA - Thekwini站点位于该国最大的结核病诊所之一，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%，将进行临床管理试验的优化。德班多丽丝·杜克医学研究所的脐带站点非常适合进行临床密集的一期试验，它也有一个性工作者队列，其艾滋病毒感染率为57.9%，每100名妇女年的发病率为9.8（年保留率：98%），用于疫苗和杀微生物剂试验。拥有1 200张床位的德班医院的Umlazi站点每年接生约12 000名产妇，9个月时艾滋病毒感染率为50.7%，母婴传播率为20%；德班初级保健诊所的Cato Manor站点每年接生1320名孕妇，9个月时艾滋病毒感染率为48.1%，母婴传播率为18%，这两个站点都将进行预防母婴传播试验。CTU行政部门有11个核心专业知识（药学、数据管理、统计、实验室、行为、卫生经济学、生物伦理学、社区参与、质量保证、监管和培训），它们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核心向每个场址提供的支助，并将确保有效的系统监测每个场址试验执行的质量。CTU执行委员会每月召开一次会议，由项目负责人、联合项目负责人、运营总监、行政经理和项目负责人组成，各站点与CTU行政部门之间进行有效沟通，并对CTU的绩效进行集体监控。此外，每个站点都有一个社区咨询委员会，由CTU社区咨询委员会的代表组成。该CTU包括在艾滋病毒网络、HPTN、HVTN和CIPRA中发挥科学领导作用的记录，随时可以接触到艾滋病毒高风险的大型队列，在核心和站点建立了具有经验丰富人员的临床试验基础设施，一个与福格蒂艾滋病培训相结合的培训计划，以及与五个网络的科学议程相一致的潜在科学贡献。

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: