Chicago D-CFAR: Clinical Core D

Core Mission

The goal of the Clinical Core is to facilitate translational HIV/AIDS research by facilitating collaborations and expanding capacity across the institutions involved in the D-CFAR. The Clinical Core serves as a resource for investigators in the design and conduct of clinical research locally and internationally. In keeping with the overall goal of the D-CFAR, the Core assists basic science and behavioral researchers in expanding the scope of their investigations into the clinical arena. Particular emphasis is placed on assisting young clinician investigators and those new to HIV research in study design and implementation. The Core is based at the Ruth M. Rothstein CORE Center of Cook County Health and Hospitals System which serves over 5,000 HIV-infected men, women and children.

 

Core Objective

• Assist clinician investigators at Rush, UIC and the Cook County Health and Hospitals System with study design
• Facilitate collaboration between and among clinician investigators, basic scientists and social and behavioral scientists across the three D-CFAR institutions
• Provide CFAR members assistance with recruitment and enrollment into HIV research
• Provide high quality data and specimens to facilitate HIV research

 

Core Services

HIV Specimen Repository
The HIV Specimen Repository is a collection of frozen serum, plasma and PBMC specimens donated by HIV-infected patients cared for at the Ruth M. Rothstein CORE Center. Specimens are linked to clinical data, offering immediate access to large numbers of well characterized samples for pilot and translational studies. Specimen-linked data which are available include virologic, immunologic status, demographic characteristics and some data on behavior and co-morbid illnesses. Requests for specimens are reviewed by the Clinical Core Steering Committee and must be approved before specimens are made available.

The Repository can also serve as a specimen collection and storage service for approved investigators who lack the funds or infrastructure to procure the clinical specimens necessary for their research.
Clinical Core Service Request Form

Epidemiologist Support
The Clinical Core Epidemiologist is available to assist members on a variety of data and study design issues including Cook County Health and Hospitals Systems (including CORE Center, Stroger Hosptial and Cermak Health Systems) database queries. Consultation on study and database design, power calculations, support with data management and statistical analysis, are also available. To encourage research efforts a basic one hour, one on one meeting with the epidemiologist is offered free of charge to young investigators and members applying for pilot grants by contacting Karen Kroc. Requests for more involved Epidemiologist services are reviewed and approved by the Clinical Core Steering Committee.
Clinical Core Service Request Form

HIV Research Study Participant Screening and Patient Referral
Experienced clinical trials research staff at the CORE Center are available to assist investigators with identification of research participants, in the development of recruitment plans and study coordination support. The staff also has the capability of facilitating real-time specimen collection, transportation and storage of biological samples and conduct of minimal risk research in the HIV clinic.

Requests for assistance with participant screening and referral are reviewed and approved by the Clinical Core Steering Committee.

Clinical Core Service Request Form

Project Design and Regulatory (IRB) Support
The Clinical Core can review study proposals and provide guidance for optimal study design, including randomization schemas, sample size/power calculations, statistical hypothesis generation, logistical issues with implementation and suggestions for data collection and analysis.  The Clinical Core can also facilitate the process of IRB submissions for faculty, fellows, new researchers and translational researchers who do not have a great deal of experience with human subjects research.  Assistance is available in the preparation and submission of IRB applications and yearly continuing reviews for the Cook County Health and Hospitals System IRB. Development of informed consent forms for IRB submission is also available.  Requests for IRB assistance are reviewed by the Clinical Core Steering Committee and must be approved before a consultation can be scheduled.
Clinical Core Service Request Form

Please complete the appropriate request form and email to Karen Kroc (click on name for email)

For funded grants there are charges for Clinical Core services. Pilot grants and service for unfunded investigators can often be accommodated without charge. Summary of Clinical Core charges

Please contact Karen Kroc for additional information.

Core Contacts

Director:  Audrey French, MD

Dr. Audrey French is a member of the Division of Infectious Diseases at Stroger (Cook County) Hospital and an Associate Professor at Rush Medical College. She has been involved in clinical care of HIV-infected persons and clinical and epidemiologic research of HIV for more than 15 years. She has served as the Director of Research at the CORE Center, since it opened in 1998 and has been the Co-Principal Investigator of the Chicago WIHS since 1996. Dr. French also chairs the Institutional Review Board for the Cook County Health and Hospitals System.  Her research focuses on HIV in women and hepatitis co-infection.

Co-Director: Richard Novak, MD

Dr. Richard Novak is a professor of Medicine and Infectious Diseases at the University of Illinois at Chicago, where he has worked for the past 30 years. He has been actively involved in HIV clinical care for 25 years and serves as the Director of the UIC HIV Community Clinic Network, which he began in 1991, a network of seven HIV community-based clinical and research sites located throughout Chicago. He is the principle investigator of the clinical trials unit for the NIAID-funded HIV Vaccine Trials Network (HVTN), and the site P.I. for the CDC sponsored HIV Outpatient Study, a multicenter observational database. He also is an investigator for the START study sponsored by the INSIGHT network and NIAID. His laboratory research has focused on the immunopathogenesis of HIV transmission in women.

Program Director: Karen Kroc

Karen Kroc is the Associate Director of Research at the CORE Center and has worked in HIV/AIDS research since 1996.  In her capacity at the CORE Center, Ms Kroc advises investigators wishing to undertake clinical research on feasibility issues and available resources. She has experience facilitating collaborations across the D-CFAR institutions and with city and state government. She has been Project Director of numerous HIV studies including most recently a multisite study of rapid HIV testing. Ms Kroc coordinates the activities of the Clinical Core and is the initial contact for the Core, assisting investigators in accessing research resources through the Clinical Core, other Cores and other D-CFAR collaborators.

 

Steering Committee

Oluwatoyin Adeyemi, MD (CORE, CCHHS)	Mardge Cohen, MD (CORE)
Mariam Aziz, MD (Rush)	Bev Sha, MD (Rush)
Mieoak Bahk (CORE)	Britt Livak, (CORE, CCHHS)
Audrey French, MD (CORE)	Karen Kroc (CORE)
Ronald Lubelchek, MD (CORE,CCHHS)	Richard Novak, MD (UIC)
Kathleen Weber (CORE)

 

For more information, contact Karen Kroc, Program Director at :

Ruth M. Rothstein CORE Center
2020 W. Harrison St.
Chicago, IL 60612
Email: kkroc@cookcountyhhs.org
Phone: (312) 572-4765
Fax: (312) 572-4559