Project Summary/Abstract This application requests renewal of funding to serve as the Statistical and Data Management Center of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). IMPAACT is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for infants, children, adolescents, and pregnant and breastfeeding women living with HIV. Specifically: to evaluate novel and durable interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control HIV replication in the absence of antiretroviral treatment (“ART-free remission”); to improve the diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve the prevention and treatment of complications and co-infections of HIV. The application's specific aims and long-term objectives are: to support the international research agenda of IMPAACT by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who have a deep interest in research in HIV infection and its complications and co-infections; to support the development, conduct and analysis of IMPAACT studies with expert statistical and data management leadership and high quality clinical and laboratory data management and communications systems which comply with regulatory requirements, meet industry standards and are fully integrated into quality management system workflows; and to advance the mission of IMPAACT through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of IMPAACT and promote harmonization and data sharing with collaborating organizations. The proposed SDMC consists of two components. One is a Statistical and Data Analysis Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership. The second is a Data Management Center at Frontier Science & Technology Research Foundation which will provide expertise and leadership in data management systems and has primary responsibility for data collection, quality and integrity.

Project Narrative The expertise provided by the Statistical and Data Management Center will help advance research concerning the treatment of infants, children, adolescents, pregnant and breastfeeding women living with HIV and co-infections such as tuberculosis. It will achieve this by ensuring that IMPAACT clinical trials and other studies are designed, conducted, and analyzed efficiently and to the highest standards using state-of-the-art, compliant clinical and laboratory information management systems that ensure complete and high-quality data. This research will continue to make significant contributions in advancing optimal treatment of infants, children, adolescents, pregnant and breastfeeding women living with HIV both in the United States and internationally.