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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-BP-A (S1))
Program Officer
Miller, Judith A
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Harvard University
Biostatistics & Other Math Sci
Schools of Public Health
United States
Zip Code
Gupta, Amita; Mathad, Jyoti S; Abdel-Rahman, Susan M et al. (2016) Toward Earlier Inclusion of Pregnant and Postpartum Women in Tuberculosis Drug Trials: Consensus Statements From an International Expert Panel. Clin Infect Dis 62:761-9
Hughes, Paul; Deng, Wenjie; Olson, Scott C et al. (2016) Short Communication: Analysis of Minor Populations of Human Immunodeficiency Virus by Primer Identification and Insertion-Deletion and Carry Forward Correction Pipelines. AIDS Res Hum Retroviruses 32:296-302
Brummel, Sean S; Singh, Kumud K; Maihofer, Adam X et al. (2016) Associations of Genetically Determined Continental Ancestry With CD4+ Count and Plasma HIV-1 RNA Beyond Self-Reported Race and Ethnicity. J Acquir Immune Defic Syndr 71:544-50
Beneri, C A; Aaron, L; Kim, S et al. (2016) Understanding NIH clinical case definitions for pediatric intrathoracic TB by applying them to a clinical trial. Int J Tuberc Lung Dis 20:93-100
Fowler, Mary G; Qin, Min; Fiscus, Susan A et al. (2016) Benefits and Risks of Antiretroviral Therapy for Perinatal HIV Prevention. N Engl J Med 375:1726-1737
Kapogiannis, Bill G; Leister, Erin; Siberry, George K et al. (2016) Prevalence of and progression to abnormal noninvasive markers of liver disease (aspartate aminotransferase-to-platelet ratio index and Fibrosis-4) among US HIV-infected youth. AIDS 30:889-98
Barlow-Mosha, Linda; Angelidou, Konstantia; Lindsey, Jane et al. (2016) Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial. Clin Infect Dis 63:1113-21
Wolf, Elizabeth; Herbeck, Joshua T; Van Rompaey, Stephen et al. (2016) Phylogenetic Evidence of HIV-1 Transmission Between Adult and Adolescent Men Who Have Sex with Men. AIDS Res Hum Retroviruses :
Price, Joan T; Wheeler, Stephanie B; Stranix-Chibanda, Lynda et al. (2016) Cost-Effectiveness of Pre-exposure HIV Prophylaxis During Pregnancy and Breastfeeding in Sub-Saharan Africa. J Acquir Immune Defic Syndr 72 Suppl 2:S145-53
Foca, Marc; Yogev, Ram; Wiznia, Andrew et al. (2016) Rilpivirine Pharmacokinetics Without and With Darunavir/Ritonavir Once Daily in Adolescents and Young Adults. Pediatr Infect Dis J 35:e271-4

Showing the most recent 10 out of 93 publications