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 #
2UM1AI068617-08
Application #
8555019
Study Section
Special Emphasis Panel (ZAI1-TS-A (S1))
Program Officer
Gilbreath, Michael J
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2014-01-01
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$4,083,600
Indirect Cost
$1,562,555
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Rosenberg, Molly; Pettifor, Audrey; Twine, Rhian et al. (2018) Evidence for sample selection effect and Hawthorne effect in behavioural HIV prevention trial among young women in a rural South African community. BMJ Open 8:e019167
Buchanan, Ashley L; Vermund, Sten H; Friedman, Samuel R et al. (2018) Assessing Individual and Disseminated Effects in Network-Randomized Studies. Am J Epidemiol 187:2449-2459
Palumbo, Philip J; Fogel, Jessica M; Hudelson, Sarah E et al. (2018) HIV Drug Resistance in Adults Receiving Early vs. Delayed Antiretroviral Therapy: HPTN 052. J Acquir Immune Defic Syndr 77:484-491
Ranganathan, Meghna; Heise, Lori; MacPhail, Catherine et al. (2018) 'It's because I like thingsā€¦ it's a status and he buys me airtime': exploring the role of transactional sex in young women's consumption patterns in rural South Africa (secondary findings from HPTN 068). Reprod Health 15:102
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Zhang, Yinfeng; Fogel, Jessica M; Guo, Xu et al. (2018) Antiretroviral drug use and HIV drug resistance among MSM and transgender women in sub-Saharan Africa. AIDS 32:1301-1306
Bock, Peter; Fatti, Geoffrey; Ford, Nathan et al. (2018) Attrition when providing antiretroviral treatment at CD4 counts >500cells/?L at three government clinics included in the HPTN 071 (PopART) trial in South Africa. PLoS One 13:e0195127
Montgomery, Brooke E E; Frew, Paula M; Hughes, James P et al. (2018) HIV Risk Characteristics Associated with Violence Against Women: A Longitudinal Study Among Women in the United States. J Womens Health (Larchmt) 27:1317-1326
Hill, Mandy J; Holt, Michael; Hanscom, Brett et al. (2018) Gender and race as correlates of high risk sex behaviors among injection drug users at risk for HIV enrolled in the HPTN 037 study. Drug Alcohol Depend 183:267-274

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