UNC Center for AIDS Research Core C Clinical

项目摘要/摘要-临床核心(核心C) 北卡罗来纳大学CFAR临床核心中心的使命是提供服务和资源，以生活在和 面临艾滋病毒风险，在FHI北卡罗来纳大学教堂山促进充满活力和创新的艾滋病毒临床和翻译研究 360和RTI。由约瑟夫·埃伦博士、索尼娅·纳普拉夫尼克博士和克莱尔·法雷尔领导的核心组织已经做好了应对 艾滋病高发区艾滋病病毒预防、传播、治疗和发病机制的关键新问题 负担、发病率和死亡率。经验丰富的领导力，并与实验室、临床和 地方、国家和国际的公共卫生研究创造了多样化和强大的资源。《核心》 维持全面和长期的UNC CFAR HIV临床队列(UCHCC)，与 国家和国际艾滋病毒队列合作，包括CNICs、NA-ACCORD和IeDEA。加州大学伯克利分校 将实时电子病历与常规和标准化的临床病历审查集成在一起，经过验证 和判定临床结果确定，并纵向收集生物标本，增强 通过艾滋病毒序列数据、社会行为调查、患者报告的结果、地理空间数据以及状态和 联邦可用的数据(例如，艾滋病毒检测、死亡率、美国人口普查)。加州大学伯克利分校支持将 北卡罗来纳大学肥沃的学术环境，与州公共卫生领导层的持久合作伙伴关系，以及 国际临床和研究网站。核心基础设施包括一个全职诊所嵌入式筛选器，以 从我们具有良好特征的患者群体中招募艾滋病毒携带者和有感染风险的参与者。我们的研究协调员， 监管和研究团队，支持协议制定和实施，包括潜在客户 收集范围广泛的样本，如血液、脑脊液、肠道和器官活检以及生殖道分泌物 和组织，提高临床和转化性研究以及研究人员的工作效率。我们还提供网络- 启用跟踪和数据输入系统、数据库设计和数据管理支持。整合了 更大的北卡罗来纳大学、RTI和FHI 360社区的核心促进了参与和指导学员的机会 和早期调查人员，使用核心的数据、标本和资源。核心支持NIH网络， 包括ACTG、HPTN、MACS/WIHS，并通过招募工作、提供数据、 在这些团队中拥有专业知识和领导力。我们高附加值、高成本效益和独特的服务和资源 每年为70多名研究人员提供基础实验室科学、翻译、临床、流行病学和 公共卫生研究，在这个资助周期中，有40多名Oar FRB调查人员和500多篇论文得到支持。 核心致力于在改进和扩展服务方面进行创新，不断完善和发展 获取和使用标本，扩大和丰富数据资源，加强对早期 Stage和国际调查人员，以及通过CFAR内部核心合作提供新的种子资金。 临床核心与CFAR SWGs、其他北卡罗来纳大学CFAR核心、国家CFAR和 美国国立卫生研究院的网络和项目推动和刺激了艾滋病毒研究和科学领域的深远创新。

PROJECT SUMMARY/ABSTRACT – CLINICAL CORE (CORE C) The UNC CFAR Clinical Core’s mission is to provide services and resources, centered on people living with and at risk for HIV, to foster dynamic and innovative clinical and translational HIV research at UNC Chapel Hill, FHI 360 and RTI. The Core, led by Drs. Joseph Eron, Sonia Napravnik, and Claire Farel, is positioned to respond to key emerging questions in HIV prevention, transmission, treatment, and pathogenesis in a region with high HIV burden, morbidity, and mortality. Experienced leadership and close relationships with laboratory, clinical, and public health research locally, nationally, and internationally create a diverse and robust resource. The Core sustains the comprehensive and longstanding UNC CFAR HIV Clinical Cohort (UCHCC), with partnerships in national and international HIV cohort collaborations, including CNICS, NA-ACCORD and IeDEA. The UCHCC integrates real-time electronic medical records, with routine and standardized clinical record reviews, validated and adjudicated clinical outcome ascertainments, and longitudinally collected biological specimens, augmented by HIV sequence data, socio-behavioral surveys, patient reported outcomes, geospatial data, and state and federally available data (e.g., HIV testing, mortality, US Census). The UCHCC supports research that capitalizes on UNC’s fertile academic environment, enduring partnerships with state public health leadership, and international clinical and research sites. The Core infrastructure includes a full time clinic-embedded screener to recruit participants with and at risk for HIV from our well-characterized patient populations. Our study coordinator, regulatory and research team, support protocol development and implementation, including prospective collection of a broad range of samples, such as blood, CSF, gut and organ biopsies, and genital tract secretions and tissue, enhancing clinical and translational research, and investigator productivity. We also provide web- enabled tracking and data entry systems, database design and support for data management. Integration of the Core within the larger UNC, RTI, and FHI 360 communities fosters opportunities to engage and mentor trainees and early stage investigators, using the Core’s data, specimens and resources. The Core supports NIH networks, including ACTG, HPTN, MACS/WIHS, and Ending the HIV Epidemic through recruitment efforts, data provision, expertise and leadership in these groups. Our value-added, cost-effective and unique services and resources support over 70 investigators annually with basic laboratory science, translational, clinical, epidemiology and public health research, with over 40 OAR FRB investigators and over 500 papers supported in this funding cycle. The Core is committed to innovation in improving and expanding services, to ongoing excellence and growth in acquisition and use of specimens, extension and enrichment of data resources, enhancing outreach to early stage and international investigators, and novel seed funding provision through intra-CFAR Core collaboration. The Clinical Core’s synergistic partnerships with CFAR SWGs, other UNC CFAR Cores, national CFARs and NIH networks and programs advance and stimulate far-reaching innovations in HIV research and science.