Data Management and Analysis Core

Harvard University D/B/A Harvard School Of Public Health, Boston MA

Investigators

Abstract

PROJECT SUMMARY Building on the longstanding investment from NIH to support novel and robust science focused on men and women with perinatally-acquired HIV (PHIV) and women with HIV, PHACS has designed an agile and efficient Data Management and Analysis Core (DMAC) to meet the increasingly complex research needs of data management and data sharing, statistical analysis and methodological innovation, fiscal, regulatory, and operational management, and community engagement. The PHACS Research on Immune Aging, Sexual and Reproductive Health, and Perinatal Acquisition: Elucidating Relationships in HIV (RISE) Program proposes a multi-part study utilizing a single protocol and resource infrastructure to support two scientifically distinct yet interlinked Research Projects that will advance insights on immune aging and reproductive and sexual health among these key populations. Over the past 20 years, the Harvard T.H. Chan School of Public Health (HSPH) Department of Epidemiology and Center for Biostatistics in AIDS Research have successfully served as the hub for data management, data analysis, research operations, and community-based participatory research for PHACS. In its new iteration, the DMAC, again based at HSPH, will leverage its accumulated experience and extensive expertise to: 1) Centralize and manage all data across PHACS Research Projects, and coordinate data sharing with innovative and interactive online data dashboard platforms along with deposits to NICHD DASH; 2) Lead methodological science with novel epidemiologic study designs, data collection and harmonization methods, and statistical analyses; 3) Implement the Research Projects effectively and efficiently at clinical sites, including fiscal management and research operations; and 4) Integrate meaningful community engagement throughout the entire research process. The DMAC will subcontract with 7 clinical sites, the Frontier Science Foundation for data management and data sharing support, and Westat for protocol support. Led by the complementary expertise of Paige Williams, PhD, Sue Siminski, MS, MBA, and Kunjal Patel, DSc, MPH, the DMAC is poised to serve as the central information resource of the proposed RISE Program given its well-established infrastructure, streamlined procedures, and highly experienced teams who established and maintained the PHACS foundational cohorts. Coupled with addressing important scientific questions around relationships between cumulative stress burden (allostatic load), immune aging, and reproductive and sexual health among people born with HIV and women with HIV in Research Projects 1 and 2, the DMAC will advance innovations in data management, visualizations and data sharing, data science, epidemiological and statistical methodology, and community engagement.