SUPPORT SERVICES OF THE HIV AIDS CLINICAL TRIAL NETWORKS

HIV艾滋病临床试验网络的支持服务

• 批准号: 10792689
• 负责人: BARBARA DRIVER
• 金额: $ 354.43万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-30 至 2023-11-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10792689
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Adolescent; Adolescent Development; Adolescent Medicine Trials Network; Agreement; Area; Award; Biological Assay; Brazil; Child; Childhood; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Network; Communicable Diseases; Conduct Clinical Trials; Contractor; Contracts; Country; Data Analyses; Diagnostic Procedure; Epidemiology; Equipment; Ethnic Origin; Evaluation; Family; Funding; Grant; HIV; HIV Infections; HIV Vaccine Trials Network; HIV prevention trials network; HIV vaccine; HIV-infected adolescents; HIV/AIDS; Healthcare; Human Development; Human Resources; Immunologics; Infectious Diseases Research; Infrastructure; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigational Therapies; Laboratories; Lead; Maintenance; Mediation; Medical; Methodology; Mission; Monitor; Mothers; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Natural History; Performance; Pharmacy facility; Prevention; Prevention strategy; Protocols documentation; Quality Control; Recurrence; Reproductive Health; Research; Research Activity; Research Personnel; Resources; Safety; Sampling; Security; Services; Shipping; Site; South Africa; Specific qualifier value; Specimen; Specimen Handling; System; Testing; Therapeutic; Therapeutic Research; Training; Translations; United States National Institutes of Health; Woman; Work; adolescent health; care coordination; care systems; clinical center; clinical research site; data management; flexibility; improved; inner city; laboratory equipment; laboratory facility; meetings; minority children; operation; patient population; pediatric human immunodeficiency virus; pediatric human immunodeficiency virus infection; pharmacologic; programs; protocol development; quality assurance; racial minority; repository; vaccine trial

BACKGROUND AND INTRODUCTION The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The Maternal and Pediatric Infectious Disease Branch (MPIDB) supports one of the major missions of the NICHD to enhance maternal, pediatric, and adolescent health and development. The objective or mission of this initiative is to provide support for critical infrastructure to enhance maternal, pediatric, and adolescent HIV therapeutics and prevention, including HIV vaccine research activities on a global scale. To provide opportunities to participate in therapeutic research, clinical trial centers must be situated in areas where infected women and children are located. Domestically, the vast majority of infected women and children are of minority race and ethnicity and often live in urban, inner-city areas in which the medical care system is often overwhelmed and under-funded. Internationally, continuing research in resource-limited countries is critical to address the global problem of pediatric HIV infection. The funding and conduct of clinical research in such settings offers many challenges though and requires a system that is flexible and responsive, and that ideally provides coordinated care of the mother and child together in a family-centered setting to optimize the maintenance of both woman and child in ongoing health care. SCOPE This Task Order will provide on an as needed basis the continuous and recurring logistical, technical, and administrative support needed for the implementation, maintenance, coordination, and management of a multi-site network of domestic and international clinical centers to conduct clinical trials for the evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology, and natural history of multiple aspects of HIV infection in pediatric, adolescent, and maternal patient populations.

背景和导言 尤尼斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD）的使命是领导研究和培训，以了解人类发展，改善生殖健康，提高儿童和青少年的生活，并优化所有人的能力。 孕产妇和儿童传染病分支（MPIDB）支持NICHD的主要任务之一，以加强孕产妇，儿童和青少年的健康和发展。 该倡议的目标或使命是为关键基础设施提供支持，以加强孕产妇、儿科和青少年艾滋病毒的治疗和预防，包括全球范围内的艾滋病毒疫苗研究活动。提供参与机会， 治疗研究、临床试验中心必须设在受感染妇女和儿童所在的地区。在国内，绝大多数受感染的妇女和儿童属于少数种族和族裔，往往生活在城市和市中心地区，那里的医疗保健系统往往不堪重负，资金不足。在国际上，在资源有限的国家继续开展研究对于解决全球儿科艾滋病毒感染问题至关重要。 在这种情况下，临床研究的资助和开展带来了许多挑战，需要一个灵活和反应灵敏的系统，理想情况下，在以家庭为中心的环境中为母亲和儿童提供协调一致的护理，以优化妇女和儿童在持续医疗保健中的维护。 范围 本任务指令将根据需要提供实施、维护、协调、 和管理国内和国际临床中心的多站点网络，以进行临床试验，以评估儿科，青少年和孕产妇患者人群中HIV感染多个方面的研究性治疗，诊断技术，预防策略，流行病学和自然史。