Clinical Core

临床核心的结构是最大限度地支持该联盟的目标，即定义哪些因素 女性生殖道对HIV易感性和发病的影响。核心集团的领导人都是专家 为感染艾滋病毒的妇女提供临床护理和研究，并将提供临床因素方面的专业知识 影响易感性和发病机制。核心的主要使命是提供高质量的 标本和临床数据，以支持所描述的发病机制研究和未来的试点计划。 临床核心与代表最常受影响的女性的大型队列整合在一起 在美国和国际上被艾滋病毒感染。方案项目和大团队的这种整合不仅 确保该联盟将研究有代表性的女性，但提供一种有效和成本效益高的方法 确定和招募符合特定纳入标准的研究对象。核心有四个具体的 目标：1)协调及时有效地获取高质量的临床标本，以支持 项目。核心将a)确保项目的样本以最好的方式统一收集 参与临床站点的可用方法，b)促进从 妇女机构间艾滋病毒研究(WIHS)储存库，以及其他队列储存库和c)协调 来自卢旺达妇女协会研究和评估的标本获取和运送 (RWISA)。2)向项目提供全面的、纵向的临床和实验室数据 关于研究参与者，并协助项目解释这些数据。核心将确保 支持临床数据在参与的临床站点上以一致的方式统一收集 来自现有队列的数据。3)与组织培养和病毒学实验室核心合作 确保获取、处理和运输组织的方法为 项目。4)确保以合乎道德的方式和符合 保护研究参与者的所有地方和联邦标准。为了实现这些目标，核心将 在下列情况下，聘请有经验的工作人员和经过充分研究的样本采集技术 将研究必要的、新颖的标本采集技术，以适应项目的独特需求。这个 CORE的设计具有灵活性，可以从许多人中招募感染艾滋病毒和未感染艾滋病毒的女性 种族和民族群体，代表广泛的艾滋病毒疾病阶段和风险特征 高效率和尊重研究参与者的自主性和贡献。 相关性(请参阅说明)： 艾滋病毒的异性传播是世界范围内艾滋病毒的主要传播方式。更好 了解妇女艾滋病毒的易感性和致病机制问题对于优化 预防艾滋病毒向妇女、男子和婴儿传播的战略。

The Clinical Core is structured to be maximally supportive of the consortium's goal of defining factors which nfluence HIV susceptibility and pathogenesis in the female genital tract. The leaders of the Core are experts n both clinical care and research for women with HIV and will provide expertise in the clinical factors affecting susceptibility and pathogenesis. The primary mission of the Core is to provide high-quality specimens and clinical data to support the described pathogenesis investigations and future pilot initiatives. The Clinical Core is integrated with large cohorts which are representative of the women most often affected by HIV in the US and internationally. This integration of the program project and the large cohorts not only assures that the consortium will study representative women but offers an efficient and cost-effective means of identifying and recruiting research subjects fitting specific inclusion criteria. The Core has four specific aims: 1) To coordinate the timely and efficient acquisition of high-quality clinical specimens to support the Projects. The Core will a) assure that specimens for the projects are collected uniformly and by the best available methodologies across participating clinical sites, b) facilitate acquisition of specimens from the Women's Interagency HIV Study (WIHS) repository, and repositories of other cohorts and c) coordinate specimen acquisition and shipping from the Rwandan Women's Interassociation Study and Assessment (RWISA). 2) To provide the Projects with access to comprehensive, longitudinal clinical and laboratory data on research participants and to assist the Projects in interpretation of these data. The Core will assure that supporting clinical data are collected uniformly across participating clinical sites and in a manner concordant with data from existing cohorts. 3) To collaborate with the Tissue Culture and Virology Laboratory Core to assure that methods of acquiring, processing and transporting tissue provide optimal specimens for the Projects. 4) To assure that recruitment of patients is performed in an ethical manner and in accordance with all local and federal standards for the protection of research participants. To fulfill these aims, the Core will employ the experienced staff and well-studied specimen collection techniques of the cohorts, when necessary, novel specimen collection techniques will be studied to fit the unique needs of the Projects. The Core has been designed to have the flexibility to recruit HIV-infected and uninfected women from many racial and ethnic groups and representing a broad range of HIV disease stages and risk characterics efficiently and with respect for the autonomy and contributions of the research participants . RELEVANCE (Seeinstructions): Heterosexual transmission of HIV is the primary mode of transmission of HIV worldwide. Better understanding of issues of susceptibility and pathogenesis of HIV in women is important in order to optimize strategies for prevention of HIV transmission to women, men and infants.