This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is one of three applications comprising the Leadership Group of the HPTN. The HPTN scientific agenda focuses exclusively on RFA priority number 6: """"""""Prevention of HIV Infection."""""""" This application describes how the Statistical Center for HIV/AIDS Research &Prevention (SCHARP) will achieve the aims of the RFA to (1) provide statistical leadership for the design, conduct, analysis and publication of Network clinical trials/studies;(2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results;(3) provide data management and protocol training throughout the Network;(4) provide data- focused clinical trials implementation, and operation;and (5) contribute to cross-Network efforts in developing common data elements and data interfaces. SCHARP has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. Thus, the systems we propose to use for data collection, managment, monitoring, and analysis are all well tested and in accordance with ICH guidelines. SCHARP statisticians will also develop and deploy novel statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials. The HIV/AIDS epidemic continues to expand in almost all regions of the world, with approximately 4.8 million new infections in 2003 (UNAIDS 2004 Report on the Global AIDS Epidemic). Although finding a vaccine to protect against infection and/or disease progression is a public-health priority, it is recognized that this goal may be years away. Therefore, the need for finding other types of effective prevention measures is critical. Only through clinical trials held to the highest scientific and regulatory standards will this goal be achieved.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01AI068617-05
Application #
7900410
Study Section
Special Emphasis Panel (ZAI1-TH-A (J2))
Program Officer
Chow, Grace C
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2011-05-31
Support Year
5
Fiscal Year
2010
Total Cost
$4,752,947
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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Greer, Amy E; Ou, San-San; Wilson, Ethan et al. (2017) Comparison of Hepatitis B Virus Infection in HIV-Infected and HIV-Uninfected Participants Enrolled in a Multinational Clinical Trial: HPTN 052. J Acquir Immune Defic Syndr 76:388-393
Jennings, Larissa; Pettifor, Audrey; Hamilton, Erica et al. (2017) Economic Resources and HIV Preventive Behaviors Among School-Enrolled Young Women in Rural South Africa (HPTN 068). AIDS Behav 21:665-677
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Dimitrov, Dobromir T; Mâsse, Benoît R; Donnell, Deborah (2016) PrEP Adherence Patterns Strongly Affect Individual HIV Risk and Observed Efficacy in Randomized Clinical Trials. J Acquir Immune Defic Syndr 72:444-51
Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 72:304-9
Safren, Steven A; Mayer, Kenneth H; Ou, San-San et al. (2015) Adherence to Early Antiretroviral Therapy: Results From HPTN 052, a Phase III, Multinational Randomized Trial of ART to Prevent HIV-1 Sexual Transmission in Serodiscordant Couples. J Acquir Immune Defic Syndr 69:234-40
Rosenberg, Molly; Pettifor, Audrey; Van Rie, Annelies et al. (2015) The Relationship between Alcohol Outlets, HIV Risk Behavior, and HSV-2 Infection among South African Young Women: A Cross-Sectional Study. PLoS One 10:e0125510
Piwowar-Manning, Estelle; Fogel, Jessica M; Richardson, Paul et al. (2015) Performance of the fourth-generation Bio-Rad GS HIV Combo Ag/Ab enzyme immunoassay for diagnosis of HIV infection in Southern Africa. J Clin Virol 62:75-9
Mindry, Deborah L; Knight, Lucia; van Rooyen, Heidi (2015) Men's moralising discourses on gender and HIV risk in rural KwaZulu-Natal, South Africa. Cult Health Sex 17:1035-48

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