SUPPORT SERVICES OF THE HIV AIDS CLINICAL TRIAL NETWORKS

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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.