This application to RFA-AI-19-002 is to continue as the statistical and data management center (SDMC) for the HIV Prevention Trials Network (HPTN). The overarching goal of the HPTN is to identify acceptable, feasible, safe, effective, and scalable interventions for HIV prevention that address the needs of populations at risk in the US and around the world. The HPTN will address this goal through identifying: 1) new biomedical products and tools for HIV prevention that have unique characteristics, such as longer duration of action, new targets of HIV inhibition or as multi-purpose technologies; 2) integrated strategies that optimize use of proven efficacious prevention interventions tailored to specific populations at risk to achieve maximal public health impact. The HPTN SDMC is housed at the Fred Hutchinson Cancer Research Center in Seattle and takes advantage of the particular strengths of the institution, which also includes the HVTN SDMC, and data and coordinating centers for several other research networks. The HPTN SDMC has faculty biostatisticians experienced in the design, conduct and analysis of global HIV prevention studies, who support the goals of HPTN research through leadership in statistical design, trial conduct and analysis, and development and implementation of innovative statistical methods as needed and motivated by HPTN scientific goals. The SDMC provides regulatory compliant data management functions for all HPTN trials, including electronic data capture directly from research sites, integration of laboratory specimens and assay results, and electronic participant reported outcomes. During the grant period, the SDMC will design and analyze Phase 1-3 trials of both antiretroviral and broadly neutralizing monoclonal antibody (bNAb) products, including completion of two Phase 3 active-controlled randomized clinical trials (RCTs) of long-acting cabotegravir (CAB LA) and two Phase 3 placebo-controlled RCTs of the bNAb VRC-01. The SDMC will fully support the development pathway for multi-purpose technologies, encompassing both acceptability and user-based design. If CAB LA proves efficacious, it will be incorporated into integrated strategy trials for populations at risk. Trial designs for integrated strategies will range from individual-randomized, to cluster-randomized (either parallel or step-wedge), to non-randomized trials, depending on the context and population. Mathematical modeling will estimate the population impact and cost- effectiveness of successful HPTN interventions in specific populations at risk. The SDMC will continue to deliver high-quality, timely, cost-efficient, and secure data management and safety monitoring functions for HPTN trials. State-of-the-art systems for data acquisition, storage, quality control, curation, and annotation, will be compliant with Clinical Data Interchange Standards Consortium (CDISC) and maintained using a continuous quality improvement strategy. HPTN socio-behavioral research is supported through flexible data interface processes with external data sources including mobile apps, SMS, tablets, and electronic Patient Reported Outcomes.

Public Health Relevance

This application to RFA-AI-19-002 is to continue as the statistical and data management center (SDMC) for the HIV Prevention Trials Network, which plans to 1) conduct a program of Phase 1-3 trials for testing new agents (antiretrovirals, broadly neutralizing monoclonal antibodies and multi-purpose technologies) for the prevention of HIV infection and 2) evaluate integrated strategy interventions that optimize use of proven efficacious prevention interventions tailored to specific populations at risk. The HPTN SDMC has faculty biostatisticians experienced in the design, conduct and analysis of global HIV prevention studies, who support the goals of HPTN research through leadership in statistical design, trial conduct and analysis, and development and implementation of innovative statistical methods as needed and motivated by HPTN scientific goals. The SDMC provides regulatory compliant data management functions for all HPTN trials, including electronic data capture directly from research sites, integration of laboratory specimens and assay results, and electronic participant reported outcomes.

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 #
2UM1AI068617-15
Application #
9986472
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Gilbreath, Michael J
Project Start
2006-06-29
Project End
2027-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
15
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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
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
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
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
Grant, Robert M; Mannheimer, Sharon; Hughes, James P et al. (2018) Daily and Nondaily Oral Preexposure Prophylaxis in Men and Transgender Women Who Have Sex With Men: The Human Immunodeficiency Virus Prevention Trials Network 067/ADAPT Study. Clin Infect Dis 66:1712-1721
Wood, Daniel; Lancaster, Kathryn E; Boily, Marie-Claude et al. (2018) Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently? J Acquir Immune Defic Syndr 77:350-357
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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