South Africa MRC HIV Prevention Trials Unit

南非 MRC HIV 预防试验单位

• 批准号: 7578322
• 负责人: GITA RAMJEE
• 金额: $ 2061.29万
• 依托单位: MEDICAL RESEARCH COUNCIL OF SOUTH AFRICA
• 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/7578322
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Affect; Behavioral Research; Caring; Clinical; Clinical Trials Unit; Communities; Counseling; Data; Ensure; Epidemic; Ethics; HIV; HIV Seropositivity; HIV prevention trial; HIV/STD; Home environment; Human; Incidence; Individual; Intervention; Leadership; Operative Surgical Procedures; Population; Populations at Risk; Positioning Attribute; Prevalence; Prevention; Prevention education; Research; Resources; Screening procedure; South Africa; Training and Infrastructure; base; clinical research site; flexibility; interdisciplinary approach; organizational structure; prevention clinical trial; programs; response

DESCRIPTION (provided by applicant): The organizational structure of the proposed Clinical Trials Unit will comprise an Administrative Component and five Clinical Research Sites (Chatsworth, Umkomaas, Botha's Hill, Overport, Hlabisa) located in Durban, South Africa. The Administrative Component includes the CTU PI/Director, the CTU Co-PI/Deputy Director and two core staff groups; the Research Core and the Administrative Core. This Administrative Component will provide leadership to both stimulate and manage the Network research agenda, and ensure the highest scientific standards, ethical integrity and efficient fiscal and clinical operations within the CTU. The proposed Clinical Research Sites, staffed with highly competent teams, were selected based on available HIV/STI prevalence and incidence data, access to specific populations most affected by the HIV/AIDS epidemic, existing community partnerships, developed infrastructure, trained staff and established HIV prevention and treatment referral strategies for those identified as HIV positive at screening and those who seroconvert in prevention trials. These optimally configured Clinical Research Sites prominently positions the CTU to address the entire continuum of research needs within the HIV epidemic from prevention for HIV negative at-risk population, to treatment and care for HIV positive individuals. The CTU will have the flexibility and capability to conduct multiple studies at multiple Clinical Research Sites allowing for rapid response to the evolving epidemic, and ensuring optimal use of resources, both human and operational. Our research plan is to affiliate with both the HPTN and MTN Networks primarily due to our excellent track record in HIV prevention clinical trials. The Umkomaas, Overport and Botha's Hill Clinical Research Sites will participate in both Networks; while the Chatsworth and Hlabisa Clinical Research Sites will be dedicated to the MTN only. We intend to use a multidisciplinary approach to implement HIV prevention, treatment and behavioral research interventions, enhancing the CTUs ability to significantly contribute to addressing the HIV/AIDS epidemic locally, nationally and internationally. More importantly, we aim for research to benefit our communities by ensuring extensive community-wide HIV prevention education, home-based care/and lay counseling programs, at all Clinical Research Sites. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：拟定临床试验部门的组织结构将包括一个行政部门和位于南非德班的五个临床研究中心（查茨沃斯、Umkomaas、博塔山、奥弗波特、Hlabisa）。行政部门包括CTU PI/主任，CTU Co-PI/副主任和两个核心工作人员小组;研究核心和行政核心。 该行政部门将提供领导，以激励和管理网络研究议程，并确保CTU内的最高科学标准，道德诚信和有效的财政和临床运作。根据现有的艾滋病毒/性传播感染流行率和发病率数据、接触受艾滋病毒/艾滋病流行影响最严重的特定人群的情况、现有的社区伙伴关系、发达的基础设施、经过培训的工作人员以及为筛查时确定为艾滋病毒阳性的人和在预防试验中血清转化的人制定的艾滋病毒预防和治疗转诊战略，选择了配备有高素质团队的拟议临床研究中心。这些最佳配置的临床研究中心突出了CTU的地位，以满足艾滋病毒流行病中从预防艾滋病毒阴性高危人群到治疗和护理艾滋病毒阳性个体的整个研究需求。 CTU将具有在多个临床研究中心进行多项研究的灵活性和能力，从而能够对不断变化的流行病做出快速反应，并确保人力和业务资源的最佳利用。我们的研究计划是与HPTN和MTN网络建立联系，主要是因为我们在艾滋病毒预防临床试验方面拥有出色的记录。Umkomaas、Overport和博塔山临床研究中心将参与这两个网络;而查茨沃斯和Hlabisa临床研究中心将仅致力于MTN。 我们打算采用多学科方法来实施艾滋病毒预防、治疗和行为研究干预措施，提高反恐小组的能力，为在地方、国家和国际各级应对艾滋病毒/艾滋病流行病作出重大贡献。更重要的是，我们的目标是通过确保在所有临床研究中心开展广泛的社区艾滋病预防教育、家庭护理和非专业咨询计划，使研究造福于我们的社区。 行政部门：