ICAP Clinical Trials Unit

ICAP 临床试验单位

基本信息

批准号：
10531542
负责人：
WAFAA M. EL-SADR
金额：
$ 206.43万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
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/10531542
关键词：
AIDS prevention Acquired Immunodeficiency Syndrome Address Adolescent Affect Africa South of the Sahara Authorization documentation Behavior Therapy Behavioral Caring Characteristics Child Clinical Research Clinical Trials Clinical Trials Network Clinical Trials Unit Collaborations Communities Community Health Education County Dedications Development Education 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 New York New York City Participant Pathogenesis Performance Persons Pharmacy facility Phase Population Positioning Attribute Postpartum Women Pregnant 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 Research Training United States United States National Institutes of Health Universities Vertical Disease Transmission Woman Youth authority black men who have sex with men clinical research site co-infection community engagement comorbidity data management design experience girls global health implementation science improved innovation men men who have sex with men men who have sex with men and women novel outreach quality assurance recruit response skills stem tool transmission process women of color working group young adult young woman

项目摘要

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.

项目概要/摘要尽管全球艾滋病毒应对工作取得了很大成就，但仍然存在巨大挑战。只有60% 2018 年，艾滋病毒感染者 (PLWH) 获得治疗，报告新增艾滋病毒感染者 170 万人。撒哈拉非洲，消除母婴传播已陷入停滞，男性和青年知识落后青少年艾滋病毒感染状况中，五分之四是女孩，而年轻女性是女孩的两倍男性可能感染艾滋病毒。在美国，自 2013 年以来，每年新增艾滋病毒感染人数一直保持稳定，与男性发生性关系的黑人和拉丁裔男性（MSM）以及有色人种女性受到的影响尤为严重。位于哥伦比亚大学 ICAP 的 ICAP 临床试验部门 (ICAP CTU) 将监督研究五个临床研究中心 (CRS)：三个位于纽约市 (NYC)，一个位于斯威士兰，一个位于肯尼亚西部。纽约市的站点为与当前艾滋病毒流行密切相关的优先人群提供服务，包括生活在艾滋病毒中或生活在艾滋病毒中的人群。艾滋病毒风险，包括黑人和拉丁裔男男性接触者、有色人种女性、年轻人和注射吸毒者（注射吸毒者）。斯威士兰和肯尼亚的站点位于一些新发艾滋病毒感染率最高的社区全世界有能力让儿童、青少年、处于危险中的妇女、男性和关键人群参与其中。由博士领导。 Wafaa El-Sadr 和 Jessica Justman 表示，ICAP CTU 将追求创新和艾滋病毒预防和治疗研究的综合方法，根据情况定制工具和策略居住在该地区或居住在该地区的人的人口特征、行为风险、合并症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，以适应复杂性个人层面对众多人群的干预措施的反应，并重点关注将支持减少人口层面的艾滋病毒感染，提高艾滋病毒感染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 HIV 网络的科学议程促进有效的艾滋病毒预防、治疗和护理干预措施的发展，目标是改善艾滋病毒感染者的生活并阻止艾滋病毒传播；（二）构建强有力的CTU行政架构能力突出、程序精简、高效、透明、界限清晰权威、持续的质量改进、社区的充分参与和最高的绩效标准； (3) 通过 CRS 的教育、外展和支持与其服务的社区充分互动社区咨询委员会； (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； (5) 将组成的 CRS 调整为一个真正多能的有凝聚力和协同作用的单位，可以有效地推进研究议程通过发展新的研究概念建立网络；参与网络协议、科学委员会和工作组；以及多样化参与者的强劲增长和保留。