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
Shanaube, Kwame; Schaap, Ab; Floyd, Sian et al. (2017) What works - reaching universal HIV testing: lessons from HPTN 071 (PopART) trial in Zambia. AIDS 31:1555-1564
MacPhail, Catherine; Khoza, Nomhle; Selin, Amanda et al. (2017) Cash transfers for HIV prevention: what do young women spend it on? Mixed methods findings from HPTN 068. BMC Public Health 18:10
Chen, Iris; Zhang, Yinfeng; Cummings, Vanessa et al. (2017) Analysis of HIV Integrase Resistance in Black Men Who Have Sex with Men in the United States. AIDS Res Hum Retroviruses 33:745-748
Mahiané, Severin Guy; Laeyendecker, Oliver (2017) Segmented polynomials for incidence rate estimation from prevalence data. Stat Med 36:334-344
Cundale, Katie; Thomas, Ranjeeta; Malava, Jullita Kenala et al. (2017) A health intervention or a kitchen appliance? Household costs and benefits of a cleaner burning biomass-fuelled cookstove in Malawi. Soc Sci Med 183:1-10
Gilbert, Peter B; Juraska, Michal; deCamp, Allan C et al. (2017) Basis and Statistical Design of the Passive HIV-1 Antibody Mediated Prevention (AMP) Test-of-Concept Efficacy Trials. Stat Commun Infect Dis 9:
Fogel, Jessica M; Clarke, William; Kulich, Michal et al. (2017) Antiretroviral Drug Use in a Cross-Sectional Population Survey in Africa: NIMH Project Accept (HPTN 043). J Acquir Immune Defic Syndr 74:158-165
Maheu-Giroux, Mathieu; Vesga, Juan F; Diabaté, Souleymane et al. (2017) Changing Dynamics of HIV Transmission in Côte d'Ivoire: Modeling Who Acquired and Transmitted Infections and Estimating the Impact of Past HIV Interventions (1976-2015). J Acquir Immune Defic Syndr 75:517-527
Sivay, Mariya V; Li, Maoji; Piwowar-Manning, Estelle et al. (2017) Characterization of HIV Seroconverters in a TDF/FTC PrEP Study: HPTN 067/ADAPT. J Acquir Immune Defic Syndr 75:271-279
Latkin, Carl A; Van Tieu, Hong; Fields, Sheldon et al. (2017) Social Network Factors as Correlates and Predictors of High Depressive Symptoms Among Black Men Who Have Sex with Men in HPTN 061. AIDS Behav 21:1163-1170

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