Clinical Core

临床核心

• 批准号: 8135302
• 负责人: Audrey French
• 金额: $ 35.47万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8135302
• 关键词: AIDS prevention; Affect; Biometry; Clinical; Clinical Data; Collaborations; Data; Data Collection; Data Security; Disease; Epidemiology; Ethics; Ethnic group; Female; Future; Genital system; Goals; HIV; Heterosexuals; Human Resources; Infant; Investigation; Laboratories; Link; Methodology; Methods; Mission; Participant; Pathogenesis; Patient Recruitments; Predisposition; Prevention strategy; Protocols documentation; Recording of previous events; Recruitment Activity; Reporting; Research; Research Subjects; Risk; Shipping; Ships; Specimen; Staging; Structure; Techniques; Tissues; Transport Process; Woman; Work; clinical care; clinical research site; cohort; cost; design; experience; flexibility; inclusion criteria; men; novel; programs; quality assurance; racial and ethnic; repository; sample collection; tissue culture; transmission process; virology

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.

临床核心的结构是为了最大限度地支持联盟的目标，定义因素， 影响女性生殖道中的HIV易感性和发病机制。核心的领导者都是专家 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门知识 影响易感性和发病机制。核心的主要使命是提供高质量的 样本和临床数据，以支持所描述的发病机制调查和未来的试点计划。 临床核心与代表最常受影响的女性的大型队列相结合 艾滋病在美国和国际上。项目和大群体的整合不仅 保证该联合会将研究具有代表性的妇女，但提供了一种有效和具有成本效益的手段 识别和招募符合特定入选标准的研究对象。核心有四个具体的 目的：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）确保项目的标本由最好的 参与临床研究中心的可用方法，B）便于从 妇女机构间艾滋病毒研究资料库和其他群组资料库，以及c）协调 卢旺达妇女协会研究和评估的标本采集和运输 （RWISA）。2)为项目提供全面、纵向的临床和实验室数据 研究参与者，并协助项目解释这些数据。核心会保证 在参与的临床研究中心以一致的方式统一收集支持性临床数据 从现有的队列数据。3)与组织培养和病毒学实验室中心合作， 确保获取、处理和运输组织的方法为患者提供最佳标本， 项目4)确保以符合伦理的方式招募患者，并符合 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 雇用有经验的工作人员和研究充分的样本收集技术的队列，当 我们会研究所需的新标本收集技术，以配合工程计划的独特需要。的 核心方案的设计具有灵活性，可以从许多国家招募感染和未感染艾滋病毒的妇女， 种族和族裔群体，代表广泛的艾滋病毒疾病阶段和风险特征 在尊重研究参与者的自主权和贡献的情况下，有效地开展研究。 相关性（参见说明）： 艾滋病毒的异性性传播是艾滋病毒在世界范围内的主要传播方式。更好 了解妇女对艾滋病毒的易感性和发病机制的问题是重要的， 预防妇女、男子和婴儿感染艾滋病毒的战略。