Clinical Sciences Core
The Clinical Sciences (CS) Core provides custom services, research navigation, and clinical infrastructure to enhance and facilitate cross-disciplinary HIV research. Services draw on the CS Core’s strength in investigator-initiated clinical studies, research on non-AIDS comorbidities, and partnership building to develop new HIV treatment and prevention interventions.
Services and Resources
The CS Core provides real-time procurement services for mucosal cells and tissue (e.g. colorectal, tonsillar, 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 repository services, and also navigates CFAR members to existing biological specimens from collaborating studies, including local NIDA-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 treatment and 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.
Regulatory Consultation and Navigation
The core navigates users through regulatory processes at all Third Coast CFAR institutions, including determining exemption for laboratory or data-driven studies, obtaining single IRB oversight for collaborative projects, DAIDS clinical review for Developmental Core awardees, and reporting in the NIH Human Subjects System. The CS 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.
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 elevated risk of non-AIDS complications 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.
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 patients 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. Their 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 work with you to 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.
Research Design and Protocol 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:
- Early planning for research operations in clinical settings for new applications to NIH and the Developmental Core
- Navigation to laboratory, data management, and regulatory resources
- Full development of clinical research protocols, informed consent documents, case report forms, and standard operating procedures
Third Coast HIV Clinical Research Forum
Quarterly, the CS Core convenes at least one key representative 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 forum video/teleconferences are typically less than 30 minutes and late in the day to accommodate busy clinic schedules. Consent forms, recruitment materials, and other information is shared and stored using Box. Contact a research navigator to join the forum.
Biostatistical Consultation and Data Analysis
For biostatistical and data analysis services, the CS Core refers 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
- Methodology and experimental design
- Survey construction
- Patient Reported Outcomes
- 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