Clinical Sciences Core
Services and Resources
Clinical Research Project Development
The CS Core provides critical review of study designs and data analysis plans, as well as expert advice during research implementation, manuscript preparation, and grant applications. Services include:
- Feasibility assessment and early planning for research operations in clinical settings for new applications to NIH and the Developmental Core.
- Navigation to clinical, data, laboratory, and pharmacy resources needed to implement clinical research projects.
- Navigation and consultation with the Viral Pathogenesis Core for custom assays, or navigation to partnering clinical laboratories.
- Consultation on development of clinical research protocols, informed consent documents, case report forms, REDCap database, and standard operating procedures.
Regulatory Consultation and Navigation
The CS Core navigates users through regulatory processes at all Third Coast CFAR institutions, and advises on the need for human subjects review or exemption for clinical, laboratory or data-driven studies, obtaining single IRB approval for collaborative projects, DAIDS clinical review for Developmental Core awardees, and reporting in the NIH Human Subjects System. The core also provides regulatory services to investigators engaged in collaborative HIV research with the Chicago and Illinois Departments of Public Health. Investigators are encouraged to contact a research navigator during the application phase of a proposed project.
The CS Core provides multiple recruitment services for IRB-approved projects:
- EMR-based recruitment: Through collaborations with EMR data warehouses at Northwestern Medicine and University of Chicago Medicine, the CS Core has created tools tailored to identify people at risk for or living with HIV.
- Community engagement: The CS Core partners with community organizations that provide HIV-related health and social services throughout Chicago. Providers may be interested in learning more about studies open to their patients (e.g. complications related to aging, CVD, or investigational therapies for HIV). CFAR staff can distribute IRB-approved materials, facilitate a seminar/presentation, or determine other ways of bi-directional engagement.
- CHAMP participant registry: The Behavioral, Social, and Implementation Sciences (BSIS) Core collaborates with the CS Core to maintain a robust community-based registry of people interested in HIV research.
The CS Core provides procurement services for mucosal cells and tissue (e.g. colorectal and genital), as well as access to stored specimens from PLWH, recent seroconverters, and age-matched seronegative controls. The core works closely with Lurie Children’s Hospital Infectious Diseases Laboratory to provide specimen processing and repository services, and also navigates CFAR members to existing biological specimens from collaborating studies, including local CFAR and NIH-funded projects and resources from NIH clinical trials networks.
The CS Core’s Clinical Informatics Group (CIG) provides rich data resources from Electronic Medical Record systems at Northwestern Medicine and the University of Chicago Medicine. Available derived data sets include medical records from thousands of patients in both HIV treatment and HIV testing “cohorts” to support research on HIV screening rates, retention in care, and comorbidities. These resources also provide the foundation for innovative work using machine learning and other data-intensive sciences. Early work with these data sets is described in a CIG seminar. In addition, a recent CS Core workshop demonstrates how to apply technology design and data innovation principles to public health and clinical HIV research projects. The latest CS Core workshop provides mixed methods research exploring and implementing healthcare system interventions to increase screening and treatment for anxiety, depression, and substance use disorder at the University of Chicago Medicine Ryan White HIV clinic.
Biostatistics and Data Analysis
For biostatistical and data analysis services, the CS Core refers Third Coast CFAR members to the Biostatistics and Computational Resources Team (BCRT), housed in the Behavioral, Social, and Implementation Science (BSIS) Core. The BCRT provides consultation and direct core services in a range of quantitative methodologies. Consulting with a research navigator during the proposal development phase is encouraged. Doctoral- and masters-level services are provided on fee-for-service basis. There is no fee for initial consultation. Areas of expertise include:
- Power analysis for multiple types of study designs
- Methodology and experimental design, including stepped wedge and hybrid trials
- Survey construction
- Traditional statistical modeling (e.g., ANOVA, regression, or survival analysis)
- Latent variable modeling
- Network analyses
- Market research (discrete choice modeling and conjoint analyses)
- Referral to non-CFAR expertise at Northwestern or University of Chicago
HIV Clinical Research Forum
The CS Core convenes periodic forums for representatives from academic and community-based centers that conduct HIV clinical research in Chicago as a means to provide a central resource in which CFAR and non-CFAR organizations exchange recruitment materials, discuss patient referrals, and identify opportunities for collaborative responses to new funding opportunities. The core also promotes community-academic research collaborations with clinicians and providers throughout the city. View a workshop presented in 2021, Developing Community-Academic Research Partnerships, for tips and guidance from current and former teams engaged in collaborative HIV research.
HIV Comorbidities Forum
The CS Core provides tailored training to investigators new to HIV research to generate new tools for clinical phenotyping of people living with HIV at risk of HIV and non-HIV related comorbidities due to chronic systemic inflammation. The core also customizes curricula to support early career scholars from all disciplines in the local, NHLBI-funded K12 Career Development Program in HIV-related Cardiovascular and Sleep Comorbidities.
Babafemi O. Taiwo, MBBS, Northwestern University
Clinical Sciences Core Director
Jennifer Jao, MD, Lurie Children’s Hospital/Northwestern University
Clinical Sciences Core Co-Director
Jessica Ridgway, MD, MS, University of Chicago
Clinical Sciences Core Co-Director