The overall objective of the Data and Statistics Core is to provide program project researchers with coordinated and sophisticated data acquisition methodologies and data quality management services, expert statistical and methodological support, and archiving of research data to facilitate the conduct of project clinical trials. The specific objectives of the Data and Statistics Core are: Objective 1: To provide sophisticated data acquisition systems and data quality management services to ensure the timeliness, completeness, accuracy, uniformity, and security of collected clinical and research data. Objective 2: To provide expert statistical and methodological support forthe design, monitoring, and evaluation of the program project clinical trials. Objective 3: To ensure the integrity, safety and accessibility of electronic data through systematic on-site and off-site data archiving and implementation of a data sharing plan. This core is critical to the successful implementation of the individual trials and will leverage shared resources, methodologies, and personnel to reduce costs and increase efficiency across the program project. Data and statistical services will be provided by highly functioning data management and statistical support centers located in Tororo and Kampala, Uganda, and San Francisco, US. The core will be led by Dr. Edwin Charlebois, co-director of the UCSF CenterforAIDS Prevention Studies, UCSF CAPS Methods Core for Data Quality and Management and director ofthe Makerere University-University of California, San Francisco (MU-UCSF) Kampala Data Management Center, a NIH-approved clinical trials data management center in Kampala.

Public Health Relevance

; The Data and Statistics Core will provide access to multiple proven models of researh and clinical trial data management and best-practices via its well established data management and statistics centers in the US and Uganda, allowing for reduced costs and increased efficiency through shared resources, methods and staff cross-trained on all program project trials.

Agency
National Institute of Health (NIH)
Type
Research Program Projects (P01)
Project #
5P01HD059454-07
Application #
8706923
Study Section
Special Emphasis Panel (ZRG1)
Project Start
Project End
Budget Start
Budget End
Support Year
7
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of California San Francisco
Department
Type
DUNS #
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Jagannathan, Prasanna; Nankya, Felistas; Stoyanov, Cristina et al. (2015) IFN? Responses to Pre-erythrocytic and Blood-stage Malaria Antigens Exhibit Differential Associations With Past Exposure and Subsequent Protection. J Infect Dis 211:1987-96
Kakuru, Abel; Achan, Jane; Muhindo, Mary K et al. (2014) Artemisinin-based combination therapies are efficacious and safe for treatment of uncomplicated malaria in HIV-infected Ugandan children. Clin Infect Dis 59:446-53
Bartelink, Imke H; Savic, Rada M; Mwesigwa, Julia et al. (2014) Pharmacokinetics of lopinavir/ritonavir and efavirenz in food insecure HIV-infected pregnant and breastfeeding women in Tororo, Uganda. J Clin Pharmacol 54:121-32
Koss, Catherine A; Natureeba, Paul; Plenty, Albert et al. (2014) Risk factors for preterm birth among HIV-infected pregnant Ugandan women randomized to lopinavir/ritonavir- or efavirenz-based antiretroviral therapy. J Acquir Immune Defic Syndr 67:128-35
Conrad, Melissa D; Bigira, Victor; Kapisi, James et al. (2014) Polymorphisms in K13 and falcipain-2 associated with artemisinin resistance are not prevalent in Plasmodium falciparum isolated from Ugandan children. PLoS One 9:e105690
Young, Sera L; Plenty, Albert H J; Luwedde, Flavia A et al. (2014) Household food insecurity, maternal nutritional status, and infant feeding practices among HIV-infected Ugandan women receiving combination antiretroviral therapy. Matern Child Health J 18:2044-53
Kamya, Moses R; Kapisi, James; Bigira, Victor et al. (2014) Efficacy and safety of three regimens for the prevention of malaria in young HIV-exposed Ugandan children: a randomized controlled trial. AIDS 28:2701-9
Bigira, Victor; Kapisi, James; Clark, Tamara D et al. (2014) Protective efficacy and safety of three antimalarial regimens for the prevention of malaria in young Ugandan children: a randomized controlled trial. PLoS Med 11:e1001689
Ruel, Theodore D; Kakuru, Abel; Ikilezi, Gloria et al. (2014) Virologic and immunologic outcomes of HIV-infected Ugandan children randomized to lopinavir/ritonavir or nonnucleoside reverse transcriptase inhibitor therapy. J Acquir Immune Defic Syndr 65:535-41
Ikilezi, Gloria; Achan, Jane; Kakuru, Abel et al. (2013) Prevalence of asymptomatic parasitemia and gametocytemia among HIV-infected Ugandan children randomized to receive different antiretroviral therapies. Am J Trop Med Hyg 88:744-6

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