This application to be the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN) is one of three applications comprising the Leadership Group of the MTN. The MTN scientific agenda focuses exclusively on RFA priority number 4: """"""""Microbicides."""""""" 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, management, 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 microbicide 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 #
3UM1AI068615-07S1
Application #
8646020
Study Section
Special Emphasis Panel (ZAI1-ML-A (J1))
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2013-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2013
Total Cost
$2,419,351
Indirect Cost
$1,675,866
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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Brown 3rd, William; Giguere, Rebecca; Sheinfil, Alan et al. (2018) Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017). J Biomed Inform 80:78-86
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Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E et al. (2018) Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials 19:8-14
Balkus, Jennifer E; Brown, Elizabeth R; Palanee-Phillips, Thesla et al. (2018) Performance of a Validated Risk Score to Predict HIV-1 Acquisition Among African Women Participating in a Trial of the Dapivirine Vaginal Ring. J Acquir Immune Defic Syndr 77:e8-e10
Musara, Petina; Montgomery, Elizabeth T; Mgodi, Nyaradzo M et al. (2018) How Presentation of Drug Detection Results Changed Reports of Product Adherence in South Africa, Uganda and Zimbabwe. AIDS Behav 22:877-886
Leu, Cheng-Shiun; Giguere, Rebecca; Bauermeister, José A et al. (2018) Trajectory of use over time of an oral tablet and a rectal gel for HIV prevention among transgender women and men who have sex with men. AIDS Care :1-9

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