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

夸祖鲁纳塔尔大学 - CAPRISA HIV/AIDS 临床试验单位

• 批准号: 7571691
• 负责人: SALIM S ABDOOL KARIM
• 金额: $ 737.71万
• 依托单位: UNIVERSITY OF KWAZULU-NATAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7571691
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adherence; Adolescent; Advisory Committees; African; Area; Beds; Bioethics; Clinic; Clinical Management; Clinical Trials; Clinical Trials Unit; Communication; Communities; Country; Ensure; Gold; HIV; HIV Vaccine Trials Network; Health; Hospitals; Human Resources; IMPAACT; Incidence; Institution; Laboratories; Lead; Leadership; Medical Research; Monitor; Monitoring Clinical Trials; Operative Surgical Procedures; Patients; Performance; Persons; Pharmacy facility; Phase I Clinical Trials; Pregnancy; Prevalence; Prevention; Recruitment Activity; Research; Research Infrastructure; Research Institute; Research Personnel; Research Priority; Risk; Rural Community; Site; South Africa; System; Time; Training; Training Programs; Universities; Vaccines; Woman; base; behavioral health; cohort; data management; experience; health economics; implementation trial; meetings; microbicide; programs; quality assurance; sex; statistics; treatment trial

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:

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/艾滋病临床试验单位（CTU）汇集了来自HPTN，MTN和IMPAACT领导的三名高级研究人员，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包括六个完善的临床试验中心，这些中心在招募和保留大量预防和治疗试验队列方面有良好的记录。以农村社区为基础的CAPRISA Vulindlela中心将开展疫苗、杀微生物剂和预防试验，该中心的艾滋病毒流行率为42.7%，青少年和年轻妇女群体的发病率为每100人年8.5人（年留存率：95.0%）。Aurum-CAPRISA研究中心为金矿工人及其社区提供服务，金矿工人艾滋病毒流行率为32.1%，艾滋病毒发病率为4.1/100人年（年留存率：95.1%），将开展疫苗和临床管理优化试验。位于该国最大的结核病诊所之一的CAPRISA - Thekwini中心去年治疗了8580名新的结核病患者，艾滋病毒流行率为64.6%，抗逆转录病毒治疗依从性为95.2%，该中心将进行临床管理试验的优化。位于德班的多丽丝杜克医学研究所的翁比洛研究中心非常适合进行临床密集的I期试验，该研究中心也有一个性工作者队列，艾滋病毒流行率为57.9%，发病率为每100名妇女年9.8例（年留存率：98%），用于疫苗和杀微生物剂试验。德班一家拥有1 200张床位的Umlazi中心每年管理约12 000例分娩，艾滋病毒感染率为50.7%，9个月时母婴传播率为20%;德班一家初级卫生诊所的卡托Manor中心每年管理1 320例妊娠，艾滋病毒感染率为48.1%，9个月时母婴传播率为18%。CTU行政部门有11个核心专业知识（药学、数据管理、统计学、实验室、行为学、卫生经济学、生物伦理学、社区参与、质量保证、监管和培训），将支持研究中心级别的活动，并在适当时集中某些职能。一名经验丰富的全职业务主任将协调各核心向各研究中心提供的支助，并将确保建立有效的系统，监测各研究中心试验实施的质量。通过CTU执行委员会（由PI、共同PI、运营总监、行政经理和现场领导人组成）的月度会议，现场与CTU行政部门之间进行有效沟通，并对CTU绩效进行集体监督。此外，每个站点都有一个社区咨询委员会，其代表是CTU社区咨询委员会的成员。该CTU包括在HIVNET、HPTN、HVTN和CIPRA中的科学领导的跟踪记录，随时可以进入艾滋病毒高风险的大型队列，在核心和研究中心建立了具有经验丰富的人员的临床试验基础设施，与Fogarty艾滋病培训相结合的培训计划，以及与五个网络的科学议程相一致的潜在科学贡献。 行政部门：