DESCRIPTION (provided by applicant): This application is a proposal to serve as the Statistical and Data Management Center of the lnternational Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, as part of the IMPAACT Leadership Group (LG). The IMPAACT LG is proposing a research agenda for studies in pediatric and maternal populations to address objectives in the following NIAID high priority research areas: Vaccines of high priority to these populations; cure and/or functional cure of HIV; co-infections, co-morbidities and consequences of antiretroviral therapy; prevention of acquisition of HIV; pharmacology, drug formulate and novel interventions. Our Specific Aims are: to support the international research agenda of the IMPAACT LG by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who are committed to collaborating with IMPAACT investigators; to provide expertise and high quality clinical and laboratory data management and communications systems to support the development, conduct and analysis of IMPAACT studies; and to advance the mission of the IMPAACT LG through innovation in study design and analysis, providing leadership in cross-study analyses, developing efficient methods and systems, and promoting harmonization with collaborating networks.

The expertise provided by the SDMC will help advance research concerning the treatment and prevention of HIV and diseases such as tuberculosis and hepatitis in infants, children, adolescents, and pregnant women. It will achieve this by ensuring that IMPAACT clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal HIV treatment and prevention both in the United States and internationally.