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 #
5UM1AI068615-06
Application #
8109842
Study Section
Special Emphasis Panel (ZAI1-ML-A (J1))
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2013-05-31
Budget Start
2011-06-01
Budget End
2012-05-31
Support Year
6
Fiscal Year
2011
Total Cost
$7,435,152
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Riddler, Sharon A; Husnik, Marla; Ramjee, Gita et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 12:e0178594
Akello, Carolyne A; Bunge, Katherine E; Nakabiito, Clemensia et al. (2017) Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial. J Womens Health (Larchmt) 26:670-676
Montgomery, Elizabeth T; Noguchi, Lisa M; Dai, James Y et al. (2017) Acceptability of and Adherence to an Antiretroviral-Based Vaginal Microbicide among Pregnant Women in the United States. AIDS Behav :
Balkus, Jennifer E; Palanee-Phillips, Thesla; Reddy, Krishnaveni et al. (2017) Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception. J Acquir Immune Defic Syndr 76:e47-e51
Montgomery, Elizabeth T; van der Straten, Ariane; Chitukuta, Miria et al. (2017) ""It's inside my body and it's mine"". AIDS :
Baeten, Jared M; Brown, Elizabeth R; Hillier, Sharon L (2017) Dapivirine Vaginal Ring for HIV-1 Prevention. N Engl J Med 376:995-6
Giguere, Rebecca; Rael, Christine Tagliaferri; Sheinfil, Alan et al. (2017) Factors Supporting and Hindering Adherence to Rectal Microbicide Gel Use with Receptive Anal Intercourse in a Phase 2 Trial. AIDS Behav :
Montgomery, Elizabeth T; Mensch, B; Musara, P et al. (2017) Misreporting of Product Adherence in the MTN-003/VOICE Trial for HIV Prevention in Africa: Participants' Explanations for Dishonesty. AIDS Behav 21:481-491
Carballo-Diéguez, Alex; Balán, Ivan C; Brown 3rd, William et al. (2017) High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women. PLoS One 12:e0181607
Koss, Catherine A; Bacchetti, Peter; Hillier, Sharon L et al. (2017) Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations. AIDS Res Hum Retroviruses :

Showing the most recent 10 out of 89 publications