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.

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 #
5UM1AI068617-10
Application #
8975587
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Gilbreath, Michael J
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2015-12-01
Budget End
2016-11-30
Support Year
10
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Miller, William C; Hoffman, Irving F; Hanscom, Brett S et al. (2018) A scalable, integrated intervention to engage people who inject drugs in HIV care and medication-assisted treatment (HPTN 074): a randomised, controlled phase 3 feasibility and efficacy study. Lancet 392:747-759
Zhang, Yinfeng; Sivay, Mariya V; Hudelson, Sarah E et al. (2018) Antiretroviral Drug Use and HIV Drug Resistance Among Young Women in Rural South Africa: HPTN 068. J Acquir Immune Defic Syndr 79:315-322
Pyra, Maria; Anderson, Peter L; Hendrix, Craig W et al. (2018) Tenofovir and tenofovir-diphosphate concentrations during pregnancy among HIV-uninfected women using oral preexposure prophylaxis. AIDS 32:1891-1898
Looker, Katharine J; Rönn, Minttu M; Brock, Patrick M et al. (2018) Evidence of synergistic relationships between HIV and Human Papillomavirus (HPV): systematic reviews and meta-analyses of longitudinal studies of HPV acquisition and clearance by HIV status, and of HIV acquisition by HPV status. J Int AIDS Soc 21:e25110
Shava, Emily; Lipira, Lauren E; Beauchamp, Geetha G et al. (2018) Risky Sexual Behavior Among Individuals Receiving Buprenorphine/Naloxone Opiate Dependency Treatment: HIV Prevention Trials Network (HPTN) 058. J Acquir Immune Defic Syndr 78:300-307
Hill, Lauren M; Abler, Laurie; Maman, Suzanne et al. (2018) Hope, the Household Environment, and Sexual Risk Behaviors Among Young Women in Rural South Africa (HPTN 068). AIDS Behav 22:1908-1918
Pettifor, Audrey; Stoner, Marie; Pike, Carey et al. (2018) Adolescent lives matter: preventing HIV in adolescents. Curr Opin HIV AIDS 13:265-273
Figueroa, Dominique B; Tillotson, Joseph; Li, Maoji et al. (2018) Discovery of genetic variants of the kinases that activate tenofovir among individuals in the United States, Thailand, and South Africa: HPTN067. PLoS One 13:e0195764
Lancaster, Kathryn E; Hoffman, Irving F; Hanscom, Brett et al. (2018) Regional differences between people who inject drugs in an HIV prevention trial integrating treatment and prevention (HPTN 074): a baseline analysis. J Int AIDS Soc 21:e25195
Bekker, Linda-Gail; Roux, Surita; Sebastien, Elaine et al. (2018) Daily and non-daily pre-exposure prophylaxis in African women (HPTN 067/ADAPT Cape Town Trial): a randomised, open-label, phase 2 trial. Lancet HIV 5:e68-e78

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