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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI068616-11
Application #
9187412
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Miller, Judith A
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2016-12-01
Budget End
2017-11-30
Support Year
11
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Harvard University
Department
Biostatistics & Other Math Sci
Type
Schools of Public Health
DUNS #
149617367
City
Boston
State
MA
Country
United States
Zip Code
02115
Boivin, Michael J; Barlow-Mosha, Linda; Chernoff, Miriam C et al. (2018) Neuropsychological performance in African children with HIV enrolled in a multisite antiretroviral clinical trial. AIDS 32:189-204
Jacobson, Denise L; Lindsey, Jane C; Coull, Brent A et al. (2018) The Association of Fat and Lean Tissue With Whole Body and Spine Bone Mineral Density Is Modified by HIV Status and Sex in Children and Youth. Pediatr Infect Dis J 37:71-77
Campbell, Grant R; Bruckman, Rachel S; Herns, Shayna D et al. (2018) Induction of autophagy by PI3K/MTOR and PI3K/MTOR/BRD4 inhibitors suppresses HIV-1 replication. J Biol Chem 293:5808-5820
Itell, Hannah L; McGuire, Erin P; Muresan, Petronella et al. (2018) Development and application of a multiplex assay for the simultaneous measurement of antibody responses elicited by common childhood vaccines. Vaccine 36:5600-5608
Venkatesh, Kartik K; Morrison, Leavitt; Livingston, Elizabeth G et al. (2018) Changing Patterns and Factors Associated With Mode of Delivery Among Pregnant Women With Human Immunodeficiency Virus Infection in the United States. Obstet Gynecol 131:879-890
Swindells, S; Gupta, A; Kim, S et al. (2018) Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003). Int J Tuberc Lung Dis 22:1016-1022
Rough, Kathryn; Seage 3rd, George R; Williams, Paige L et al. (2018) Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med 378:1593-1603
Gaufin, Thaidra; Tobin, Nicole H; Aldrovandi, Grace M (2018) The importance of the microbiome in pediatrics and pediatric infectious diseases. Curr Opin Pediatr 30:117-124
Eke, Ahizechukwu C; Chakhtoura, Nahida; Kashuba, Angela et al. (2018) Rilpivirine Plasma and Cervicovaginal Concentrations in Women During Pregnancy and Postpartum. J Acquir Immune Defic Syndr 78:308-313
Buchholz, Ursula J; Cunningham, Coleen K; Muresan, Petronella et al. (2018) Live Respiratory Syncytial Virus (RSV) Vaccine Candidate Containing Stabilized Temperature-Sensitivity Mutations Is Highly Attenuated in RSV-Seronegative Infants and Children. J Infect Dis 217:1338-1346

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