This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is the third of three linked applications comprising the Leadership Group of the HPTN in response to RFA-AI-12-011: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV infection (UMI). The HPTN scientific agenda focuses on the following two areas of inquiry: 1) integrated strategies to prevent HIV infection and 2) expanding horizons for more promising pre-exposure prophylaxis (PrEP) drugs and drug regimens. This application describes how the SDMC will achieve the responsibilities described in the RFA, (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate;(ii) providing effective data communication systems for the network;(iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff;(iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other Federal and private sector clinical trial programs when required;and, (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements. The HPTN SDMC has extensive experience in the design, conduct and analysis of global prevention studies. The scientific leadership of the faculty engaged in the HPTN SDMC will ensure HPTN trials are designed to obtain reliable answers to the most pressing questions in the prevention science field. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New PrEP drugs will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will expand our data collection tools to include electronic mobile devices to facilitate assessment of communities and real-time behavioral data. We will support the leadership group with rapid, accurate reporting of HPTN studies throughout follow-up to study completion. We will continue to support the HPTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of HIV prevention trials.

Public Health Relevance

The HIV/AIDS epidemic continues to affect many regions of the world. The recent, proven success of using antiretrovirals for prevention of HIV transmission (through treatment of an HIV-infected person) and HIV acquisition (by using PrEP in an HIV-uninfected person): leads to a new goal: to identify and improve upon known methods of prevention, and to optimize and integrate these interventions to create strategies for reducing HIV in populations most severely affected by the HIV epidemic.

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-TS-A (S1))
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Gilbreath, Michael J
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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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