South Africa MRC HIV Prevention Trials Unit

南非 MRC HIV 预防试验单位

• 批准号: 8215938
• 负责人: GITA RAMJEE
• 金额: $ 1906.91万
• 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 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8215938
• 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; 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; operation; 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)：拟议的临床试验股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站点(查茨沃斯、乌姆科马亚斯、博萨山、奥弗波特、哈拉比萨)。行政部分包括反恐股PI/主任、反恐股PI/副主任和两个核心工作人员小组；研究核心和行政核心。 这一行政部门将发挥领导作用，促进和管理网络研究议程，并确保反恐联盟内最高的科学标准、道德操守和高效的财政和临床业务。拟议的临床研究地点配备了高能力的团队，是根据现有的艾滋病毒/性传播感染流行和发病率数据、接触受艾滋病毒/艾滋病疫情影响最严重的特定人群、现有的社区伙伴关系、发展基础设施、培训工作人员并为筛查时被确认为艾滋病毒阳性者和在预防试验中血清转换者制定艾滋病毒预防和治疗转诊战略来选择的。这些优化配置的临床研究站点突出地定位了CTU，以满足艾滋病毒流行中从艾滋病毒阴性高危人群的预防到艾滋病毒阳性个人的治疗和护理的整个连续研究需求。 CTU将拥有在多个临床研究地点进行多项研究的灵活性和能力，从而能够对不断演变的流行病做出快速反应，并确保最佳利用人力和业务资源。我们的研究计划是加入HPTN和MTN网络，主要是因为我们在艾滋病毒预防临床试验方面的出色记录。Umkomaas、Overport和Botha‘s Hill临床研究网站将加入这两个网络；而Chatsworth和HLabisa临床研究网站将仅致力于MTN。 我们打算使用多学科方法实施艾滋病毒预防、治疗和行为研究干预措施，加强反恐股为解决地方、国家和国际艾滋病毒/艾滋病流行病作出重大贡献的能力。更重要的是，我们的目标是通过在所有临床研究站点确保广泛的社区范围的艾滋病毒预防教育、基于家庭的护理/和咨询计划，使研究造福于我们的社区。 管理组件：