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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-TH-A (J2))
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Chow, Grace C
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Fred Hutchinson Cancer Research Center
United States
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Jennings, Larissa; Rompalo, Anne M; Wang, Jing et al. (2015) Prevalence and correlates of knowledge of male partner HIV testing and serostatus among African-American women living in high poverty, high HIV prevalence communities (HPTN 064). AIDS Behav 19:291-301
Mannheimer, Sharon B; Wang, Lei; Wilton, Leo et al. (2014) Infrequent HIV testing and late HIV diagnosis are common among a cohort of black men who have sex with men in 6 US cities. J Acquir Immune Defic Syndr 67:438-45
Knight, Lucia; McGrath, Nuala; van Rooyen, Heidi et al. (2014) Characteristics of sexually experienced HIV testers aged 18 to 32 in rural South Africa: baseline results from a community-based trial, NIMH Project Accept (HPTN 043). BMC Public Health 14:1164
Grinsztejn, Beatriz; Hosseinipour, Mina C; Ribaudo, Heather J et al. (2014) Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis 14:281-90
Whalen, Christopher J; Donnell, Deborah; Tartakovsky, Michael (2014) Supporting research sites in resource-limited settings: challenges in implementing information technology infrastructure. J Acquir Immune Defic Syndr 65 Suppl 1:S44-9
Kuo, Irene; Golin, Carol E; Wang, Jing et al. (2014) Substance use patterns and factors associated with changes over time in a cohort of heterosexual women at risk for HIV acquisition in the United States. Drug Alcohol Depend 139:93-9
Irvin, R; Wilton, L; Scott, H et al. (2014) A study of perceived racial discrimination in Black men who have sex with men (MSM) and its association with healthcare utilization and HIV testing. AIDS Behav 18:1272-8
Lucas, Gregory M; Young, Alicia; Donnell, Deborah et al. (2014) Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand. Drug Alcohol Depend 142:139-45
Coates, Thomas J; Kulich, Michal; Celentano, David D et al. (2014) Effect of community-based voluntary counselling and testing on HIV incidence and social and behavioural outcomes (NIMH Project Accept; HPTN 043): a cluster-randomised trial. Lancet Glob Health 2:e267-77
Chen, Iris; Cummings, Vanessa; Fogel, Jessica M et al. (2014) Low-level Viremia early in HIV infection. J Acquir Immune Defic Syndr 67:405-8

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