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
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Hendrix, Craig W; Andrade, Adriana; Bumpus, Namandjé N et al. (2016) Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses 32:32-43
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Ritchwood, Tiarney D; Hughes, James P; Jennings, Larissa et al. (2016) Characteristics of Age-Discordant Partnerships Associated With HIV Risk Among Young South African Women (HPTN 068). J Acquir Immune Defic Syndr 72:423-9
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Siskind, Rona L; Andrasik, Michele; Karuna, Shelly T et al. (2016) Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research. J Acquir Immune Defic Syndr 72 Suppl 3:S243-7
Latkin, Carl A; Van Tieu, Hong; Fields, Sheldon et al. (2016) Social Network Factors as Correlates and Predictors of High Depressive Symptoms Among Black Men Who Have Sex with Men in HPTN 061. AIDS Behav :
Schackman, Bruce R; Eggman, Ashley A; Leff, Jared A et al. (2016) Costs of Expanded Rapid HIV Testing in Four Emergency Departments. Public Health Rep 131 Suppl 1:71-81
Pettifor, Audrey; MacPhail, Catherine; Selin, Amanda et al. (2016) HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV Infection in Young Women in South Africa-Study Design and Baseline Results. AIDS Behav 20:1863-82
Jennings, Larissa; Pettifor, Audrey; Hamilton, Erica et al. (2016) Economic Resources and HIV Preventive Behaviors Among School-Enrolled Young Women in Rural South Africa (HPTN 068). AIDS Behav :

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