South Africa MRC HIV Prevention Trials Unit

南非 MRC HIV 预防试验单位

• 批准号: 8415773
• 负责人: GITA RAMJEE
• 金额: $ 874.81万
• 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 2013-12-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8415773
• 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; South Africa; Training and Infrastructure; base; clinical research site; flexibility; interdisciplinary approach; operation; organizational structure; prevention clinical trial; programs; response; screening

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）：拟议临床试验单位的组织结构将包括位于南非德班的一个行政部门和五个临床研究中心（Chatsworth、Umkomaas、Botha's Hill、Overport、Hlabisa）。行政部门包括 CTU PI/主任、CTU 联合 PI/副主任和两个核心工作人员小组；研究核心和行政核心。 该行政部门将领导促进和管理网络研究议程，并确保 CTU 内的最高科学标准、道德诚信以及高效的财务和临床运作。拟议的临床研究中心配备了高素质的团队，其选择依据是现有的艾滋病毒/性传播感染流行率和发病率数据、受艾滋病毒/艾滋病流行影响最严重的特定人群的接触情况、现有的社区伙伴关系、发达的基础设施、训练有素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发现血清转化的人制定的艾滋病毒预防和治疗转诊策略。这些经过优化配置的临床研究中心使 CTU 能够满足 HIV 流行期间从 HIV 阴性高危人群的预防到 HIV 阳性个体的治疗和护理的整个连续性研究需求。 CTU 将具有在多个临床研究中心开展多项研究的灵活性和能力，以便快速应对不断变化的流行病，并确保人力和运营资源的最佳利用。我们的研究计划是加入 HPTN 和 MTN 网络，主要是因为我们在 HIV 预防临床试验方面拥有出色的记录。 Umkomaas、Overport 和 Botha's Hill 临床研究中心将参与这两个网络；而 Chatsworth 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 CTU 的能力，为解决地方、国家和国际艾滋病毒/艾滋病流行问题做出重大贡献。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范围内的艾滋病毒预防教育、家庭护理/和非专业咨询计划，使研究造福我们的社区。 行政部分：