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
Ojikutu, Bisola O; Pathak, Subash; Srithanaviboonchai, Kriengkrai et al. (2016) Community Cultural Norms, Stigma and Disclosure to Sexual Partners among Women Living with HIV in Thailand, Brazil and Zambia (HPTN 063). PLoS One 11:e0153600
Hendrix, Craig W; Andrade, Adriana; Bumpus, Namandjé N et al. (2016) Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses 32:32-43
Landovitz, Raphael J; Kofron, Ryan; McCauley, Marybeth (2016) The promise and pitfalls of long-acting injectable agents for HIV prevention. Curr Opin HIV AIDS 11:122-8
Ritchwood, Tiarney D; Hughes, James P; Jennings, Larissa et al. (2016) Characteristics of Age-Discordant Partnerships Associated With HIV Risk Among Young South African Women (HPTN 068). J Acquir Immune Defic Syndr 72:423-9
Dimitrov, Dobromir T; Kiem, Hans-Peter; Jerome, Keith R et al. (2016) A curative regimen would decrease HIV prevalence but not HIV incidence unless targeted to an ART-naïve population. Sci Rep 6:22183
Siskind, Rona L; Andrasik, Michele; Karuna, Shelly T et al. (2016) Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research. J Acquir Immune Defic Syndr 72 Suppl 3:S243-7
Latkin, Carl A; Van Tieu, Hong; Fields, Sheldon et al. (2016) Social Network Factors as Correlates and Predictors of High Depressive Symptoms Among Black Men Who Have Sex with Men in HPTN 061. AIDS Behav :
Schackman, Bruce R; Eggman, Ashley A; Leff, Jared A et al. (2016) Costs of Expanded Rapid HIV Testing in Four Emergency Departments. Public Health Rep 131 Suppl 1:71-81
Pettifor, Audrey; MacPhail, Catherine; Selin, Amanda et al. (2016) HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV Infection in Young Women in South Africa-Study Design and Baseline Results. AIDS Behav 20:1863-82
Jennings, Larissa; Pettifor, Audrey; Hamilton, Erica et al. (2016) Economic Resources and HIV Preventive Behaviors Among School-Enrolled Young Women in Rural South Africa (HPTN 068). AIDS Behav :

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