ICAP Clinical Trials Unit

ICAP 临床试验单位

• 批准号: 10057719
• 负责人: WAFAA M. EL-SADR
• 金额: $ 296.37万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10057719
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adolescent; Affect; Africa South of the Sahara; Behavioral; Caring; Characteristics; Child; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Color; Communities; Community Health Education; County; Development; Education and Outreach; Elderly; Epidemic; Ethics; Foundations; Goals; HIV; HIV Infections; Health Services Accessibility; Incidence; Individual; Infection; Injecting drug user; Institution; International; Intervention; Kenya; Knowledge; Laboratories; Latino; Life; Link; Morbidity - disease rate; New York; New York City; Participant; Pathogenesis; Performance; Persons; Pharmacy facility; Phase; Population; Positioning Attribute; Postpartum Women; Prevalence; Prevention; Prevention Research; Principal Investigator; Procedures; Protocols documentation; Public Health; Public Health Schools; Quality of life; Reporting; Research; Research Personnel; Risk; Science; Scientific Advances and Accomplishments; Seasons; Site; Social Behavior; Staff Development; Structure; Therapeutic; Therapeutic Human Experimentation; Training; United States; United States National Institutes of Health; Universities; Vertical Disease Transmission; Woman; Youth; authority; base; clinical research site; co-infection; cohesion; community engagement; comorbidity; data management; design; experience; girls; global health; implementation science; innovation; men; men who have sex with men; men who have sex with men and women; novel; pregnant; quality assurance; recruit; response; skills; stem; tool; transmission process; working group; young adult; young man; young woman

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.

项目摘要/摘要 尽管全球艾滋病毒反应已经实现了很多，但仍然存在巨大的挑战。只有60％ 2018年报告了患有艾滋病毒（PLWH）的患者（PLWH）访问治疗和170万新的艾滋病毒感染。 撒哈拉非洲，消除母亲传播的母亲已经停滞不前，男人和青年落后于知识 在艾滋病毒状况中，青少年中有五种新感染中有四种发生在女孩中，年轻女性的年轻女性是 可能是男人患艾滋病毒。在美国，自2013年以来，年度新的艾滋病毒感染一直保持稳定 与男性发生性关系的黑人和拉丁裔男人（MSM）和颜色不成比例的女人受到影响。 位于哥伦比亚大学ICAP的ICAP临床试验单元（ICAP CTU）将监督研究 在五个临床研究地点（CRS）：纽约市的三个（纽约市），一个在埃斯瓦蒂尼，一个在肯尼亚西部。 纽约市地点是与当前的HIV流行相关的优先人群 艾滋病毒的风险，包括黑人和拉丁裔MSM，有色女性，年轻人以及注入毒品的人 （PWID）。埃斯瓦蒂尼（Eswatini）和肯尼亚地点 世界有能力吸引儿童，青少年，处于危险中的妇女，男人和关键人群。 由博士领导。 WAFAA EL-SADR和JESSICA JUSTMAN，ICAP CTU将追求创新的，并且 对艾滋病毒预防和治疗性研究的全面方法，以量身定制工具和策略 人口特征，行为风险，合并症和与生活的人的生活环境 获取艾滋病毒的风险。 CTU进行的研究将是多方面的，可满足复杂性 对众多人群干预措施的个人水平反应，并着重于将 支持艾滋病毒感染的人口水平减少以及PLWH生活质量和生存的改善。 ICAP CTU的具体目的是（1）推进所有四个NIH HIV网络的科学议程 通过为开发有效的HIV预防，治疗和护理干预措施做出贡献，目的是 增强PLWH的生活和诱使艾滋病毒传播； （2）建立强大的CTU管理结构 这在其能力方面非常出色，并以效率，透明性，清晰的线条在过程中精简 权威，持续的质量改进，完整的社区参与以及表现最高的 标准； （3）通过教育，宣传和CRS的支持充分参与其服务的社区 社区咨询委员会； （4）支持Core CRS技术功能，例如实验室，药房，监管， 数据管理，质量保证，培训和员工发展； （5）将组成的CRS调整为 一个真正多元化的凝聚力和协同单位，有效地推进了研究议程 通过开发新研究概念的网络；参与网络协议，科学 委员会和工作组；以及强大的应计和不同参与者的保留。