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

夸祖鲁-纳塔尔大学-南非艾滋病研究方案中心 (CAPRISA)艾滋病毒/艾滋病临床试验股(CTU)汇集了来自 领导HPTN、MTN和IMPAACT领导一个独特的南非CTU，包括 由五个伙伴机构组成的联盟，在五个研究优先领域开展研究。 为了实现这一目标，CTU包括六个久负盛名的临床试验地点，这些地点有记录表明 能够招募和保留用于预防和治疗试验的大量队列。农村社区-- 以CAPRISA Vulindlela站点为基础，艾滋病毒流行率为42.7%，发病率为8.5/100人年 在青少年和年轻女性队列中(年保留率：95.0%)将进行疫苗接种， 杀微生物剂和预防试验。Aurum-CAPRISA网站，为黄金矿工和他们的 社区，黄金矿工的艾滋病毒流行率为32.1%，每100人年艾滋病毒发病率为4.1 (年保留率：95.1%)，用于进行疫苗和临床管理优化试验。这个 位于该国最大的结核病诊所之一的CAPRISA-eThekwini网站，该诊所治疗了8580名新结核病患者 去年HIV感染率为64.6%，ART依从率为95.2%，将对临床进行优化 管理方面的试验。德班多丽丝杜克医学研究所的Umbilo遗址，这是 非常适合进行临床强化I期试验，也有57.9%的性工作者感染艾滋病毒 疫苗的流行率和发病率为每百名妇女年9.8人(年保留率：98%) 和杀微生物剂试验。乌姆拉齐医院位于德班一家有1200个床位的医院，负责大约12,000次分娩 每年艾滋病毒感染率为50.7%，9个月母婴传播感染率为20%，卡托庄园遗址为 德班初级卫生诊所，每年管理1320例妊娠，艾滋病毒流行率为48.1%， 9个月时MTCT率为18%的患者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(药学、数据管理、 统计学、实验室、行为经济学、卫生经济学、生物伦理学、社区参与、质量保证、 监管和培训)，这将支持现场一级的活动并集中某些职能，其中 恰如其分。一名经验丰富的全职运营总监将协调核心提供的支持，以 将确保建立有效的制度，以监测每个地点的试行质量。 各地点与反恐股行政部门之间的有效沟通和集体监测 通过反恐联盟执行委员会每月举行的会议来评估反恐联盟的业绩，这些会议包括 项目经理、副项目经理、运营总监、行政经理和现场负责人。此外，每个站点都有一个 社区咨询委员会，有CTU社区咨询委员会的代表。 该CTU包括在HIVNET、HPTN、HVTN和CIPRA方面的科学领先记录， 随时可以接触到艾滋病毒高危人群，建立了临床试验基础设施，拥有经验丰富的 核心和地点的人员，与Fogarty艾滋病培训相结合的培训方案，以及 潜在的科学贡献与五个网络的科学议程保持一致。

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. TheAurum - 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%) for the conduct of vaccine and clinical management optimization trials. The CAPRISA - eThekwini Site at onethe country's largest TB clinics, which treated 8580 newTB 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.