ICAP Clinical Trials Unit

项目摘要/摘要 虽然在全球应对艾滋病毒方面取得了很大成就，但仍然存在巨大的挑战。只有60%的 2018年报告了艾滋病毒携带者(PLWH)获得治疗和170万新的艾滋病毒感染病例。在子- 撒哈拉非洲，消除母婴传播停滞不前，男子和青年在知识方面落后 在艾滋病毒状况方面，青少年中有五分之四的新感染病例发生在女孩中，年轻妇女的比例是 像男性一样有可能感染艾滋病毒。在美国，自2013年以来，每年新增的艾滋病毒感染人数保持稳定， 与男性发生性关系的黑人和拉丁裔男性(MSM)和有色人种女性受到的影响不成比例。 ICAP临床试验单位(ICAP CTU)总部设在哥伦比亚大学ICAP，将监督研究 在五个临床研究地点(CRSS)：三个在纽约市(NYC)，一个在埃斯瓦蒂尼，一个在肯尼亚西部。 纽约市的这些地点为与当前艾滋病毒流行密切相关的优先人群提供服务，包括与艾滋病毒一起生活和在 艾滋病毒风险，包括黑人和拉丁裔MSM、有色人种妇女、年轻人和注射吸毒者 (PWID)。埃斯瓦蒂尼和肯尼亚的地点，在#年艾滋病毒新感染率最高的社区 儿童、青少年、处于危险中的妇女、男子和主要人群参与的能力。 在Wafaa El-Sadr博士和Jessica Justman博士的领导下，ICAP CTU将追求一种创新和 艾滋病毒预防和治疗研究的综合方法，根据需要定制工具和战略 与人同住或与人同住的人口统计特征、行为风险、共病和生活环境 感染艾滋病毒的风险。CTU进行的研究将是多方面的，适应复杂的情况 在众多人口中对干预措施作出的个人层面的反应，并侧重于将 支持在人口层面上减少艾滋病毒感染，提高妇女保健中心的生活质量和存活率。 ICAP CTU的具体目标是：(1)推进所有四个NIH艾滋病毒网络的科学议程 通过促进制定有效的艾滋病毒预防、治疗和护理干预措施，目标是 (2)建立一个强有力的CTU管理结构 它的能力突出，程序精简，效率高，透明度高，界限清晰 权威性、持续质量改进、充分的社区参与度和最高性能 标准；(3)通过教育、推广和支持社区服务中心，与其服务的社区充分接触 社区咨询委员会；(4)支持CRS的核心技术职能，例如实验室、药房、监管、 数据管理、质量保证、培训和员工发展；以及(5)将组成企业资源规划系统纳入 一个具有凝聚力和协作性的单位，真正具有多能性，并有效地推进 通过制定新的网络研究概念；参与网络协议，科学 委员会和工作组；以及不同参与者的强劲应计和留用。

PROJECT SUMMARY/ABSTRACT While much has been achieved in the global HIV response, enormous challenges remain. Only 60% of people living with HIV (PLWH) access treatment and 1.7M new HIV infections were reported in 2018. In sub- Saharan Africa, elimination of mother to child transmission has stalled, men and youth lag behind in knowledge of HIV status, four of five new infections among adolescents occur among girls, and young women are twice as likely as men to have HIV. In the United States, annual new HIV infections have remained stable since 2013, with Black and Latino men who have sex with men (MSM) and women of color disproportionately affected. The ICAP Clinical Trials Unit (ICAP CTU), based at ICAP at Columbia University, will oversee research at five clinical research sites (CRSs): three in New York City (NYC), one in Eswatini, and one in Western Kenya. The NYC sites serve priority populations of great relevance to the current HIV epidemic, both living with and at risk for HIV, including Black and Latino MSM, women of color, young people, and people who inject drugs (PWID). The Eswatini and Kenya sites, in communities with some of the highest rates of new HIV infections in the world, have the capacity to engage children, adolescents, women at risk, men and key populations. Led by Drs. Wafaa El-Sadr and Jessica Justman, the ICAP CTU will pursue an innovative and comprehensive approach to HIV prevention and therapeutic research that tailors tools and strategies to the demographic characteristics, behavioral risks, co-morbidities and life circumstances of persons living with or at risk of acquiring HIV. Research undertaken by the CTU will be multi-faceted, accommodating the complexities of individual-level responses to interventions across numerous populations, and focused on advances that will support population-level reductions in HIV infection and improvements in quality of life and survival of PLWH. The specific aims of the ICAP CTU are (1) to advance the scientific agendas of all four NIH HIV networks by contributing to the development of effective HIV prevention, treatment and care interventions, with the goal of enhancing the lives of PLWH and stemming HIV transmission; (2) to build a strong CTU administrative structure that is outstanding in its capabilities and streamlined in its procedures, with efficiency, transparency, clear lines of authority, continuous quality improvement, full community engagement, and the highest performance standards; (3) to engage fully with the communities it serves through education, outreach and support of CRS community advisory boards; (4) to support core CRS technical functions, e.g., laboratory, pharmacy, regulatory, data management, quality assurance, training and staff development; and (5) to align the constituent CRSs into a cohesive and synergistic Unit that is truly pluripotent and that effectively advances the research agendas of the networks through development of new research concepts; participation in network protocols, scientific committees and working groups; and robust accrual and retention of diverse participants.