ICAP Clinical Trials Unit

ICAP 临床试验单位

• 批准号: 10304864
• 负责人: WAFAA M. EL-SADR
• 金额: $ 212.24万
• 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/10304864
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adolescent; Affect; Africa South of the Sahara; Behavioral; Black race; Caring; Characteristics; Child; Clinical Research; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; 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; 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; women of color; 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.

项目总结/摘要 虽然全球艾滋病毒防治工作取得了很大成就，但仍然存在巨大挑战。只有60%的 艾滋病毒感染者（PLWH）获得治疗，2018年报告了170万新的艾滋病毒感染者。在亚- 撒哈拉非洲，消除母婴传播已陷入停滞，男子和青年在知识方面落后 在艾滋病毒感染状况方面，青少年中五分之四的新感染者是女孩，年轻妇女是女孩的两倍。 像男性一样有可能感染艾滋病毒。在美国，自2013年以来，每年新感染艾滋病毒的人数保持稳定， 与黑人和拉丁裔男性发生性关系的男性（MSM）和有色人种的女性受到不成比例的影响。 位于哥伦比亚大学ICAP的ICAP临床试验单位（ICAP CTU）将监督研究 在五个临床研究中心（CRS）：三个在纽约市（NYC），一个在斯威士兰，一个在肯尼亚西部。 纽约市的站点为与当前艾滋病毒流行病密切相关的优先人群提供服务，包括艾滋病毒感染者和艾滋病患者。 艾滋病毒的风险，包括黑人和拉丁美洲男男性行为者，有色人种妇女，年轻人和注射毒品的人 （PWID）。斯威士兰和肯尼亚的研究中心，在一些新的艾滋病毒感染率最高的社区， 世界各地的妇女、儿童、青少年、处境危险的妇女、男子和重点人群都有能力参与。 在Wafaa El-Sadr博士和Jessica Justman博士的领导下，ICAP CTU将追求创新和 艾滋病毒预防和治疗研究的全面方法，为艾滋病毒感染者量身定制工具和战略， 人口统计学特征、行为风险、合并症和生活环境 感染艾滋病毒的风险。反恐组进行的研究将是多方面的， 在众多人群中对干预措施的个人层面的反应，并侧重于进步， 支持在人口一级减少艾滋病毒感染，提高艾滋病毒携带者的生活质量和生存率。 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 促进制定有效的艾滋病毒预防、治疗和护理干预措施， 改善艾滋病毒感染者的生活，阻止艾滋病毒的传播;（2）建立一个强有力的CTU行政结构 这是一个能力突出、程序精简、效率高、透明度高、界限明确的机构， 权威，持续的质量改进，全面的社区参与和最高的绩效 标准;（3）通过教育，外展和CRS的支持，充分参与其服务的社区 社区咨询委员会;（4）支持核心CRS技术功能，例如，实验室、药房、监管部门 数据管理、品质保证、培训及员工发展;及（5）把各组成的客户服务系统， 一个具有凝聚力和协同作用的单位，是真正的多能性，并有效地推进研究议程， 通过发展新的研究概念，参与网络协议，科学 委员会和工作组;以及稳健的累积和留住不同的参与者。