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 with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI068617-07
Application #
8277924
Study Section
Special Emphasis Panel (ZAI1-TH-A (J2))
Program Officer
Chow, Grace C
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2012-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2012
Total Cost
$5,673,078
Indirect Cost
$3,833,755
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Miller, William C; Hoffman, Irving F; Hanscom, Brett S et al. (2018) A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet 392:747-759
Zhang, Yinfeng; Sivay, Mariya V; Hudelson, Sarah E et al. (2018) Antiretroviral Drug Use and HIV Drug Resistance Among Young Women in Rural South Africa: HPTN 068. J Acquir Immune Defic Syndr 79:315-322
Pyra, Maria; Anderson, Peter L; Hendrix, Craig W et al. (2018) Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis. AIDS 32:1891-1898
Looker, Katharine J; Rönn, Minttu M; Brock, Patrick M et al. (2018) Evidence of synergistic relationships between HIV and Human Papillomavirus (HPV): systematic reviews and meta-analyses of longitudinal studies of HPV acquisition and clearance by HIV status, and of HIV acquisition by HPV status. J Int AIDS Soc 21:e25110
Shava, Emily; Lipira, Lauren E; Beauchamp, Geetha G et al. (2018) Risky Sexual Behavior Among Individuals Receiving Buprenorphine/Naloxone Opiate Dependency Treatment: HIV Prevention Trials Network (HPTN) 058. J Acquir Immune Defic Syndr 78:300-307
Hill, Lauren M; Abler, Laurie; Maman, Suzanne et al. (2018) Hope, the Household Environment, and Sexual Risk Behaviors Among Young Women in Rural South Africa (HPTN 068). AIDS Behav 22:1908-1918
Pettifor, Audrey; Stoner, Marie; Pike, Carey et al. (2018) Adolescent lives matter: preventing HIV in adolescents. Curr Opin HIV AIDS 13:265-273
Figueroa, Dominique B; Tillotson, Joseph; Li, Maoji et al. (2018) Discovery of genetic variants of the kinases that activate tenofovir among individuals in the United States, Thailand, and South Africa: HPTN067. PLoS One 13:e0195764
Lancaster, Kathryn E; Hoffman, Irving F; Hanscom, Brett et al. (2018) Regional differences between people who inject drugs in an HIV prevention trial integrating treatment and prevention (HPTN 074): a baseline analysis. J Int AIDS Soc 21:e25195
Bekker, Linda-Gail; Roux, Surita; Sebastien, Elaine et al. (2018) Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV 5:e68-e78

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