Center for AIDS Research (CFAR) Clinical Core Director: J. Michael Kilby, MD Department/Center Association: CFAR Established: 1988 Mission The CFAR Clinical Core was established to provide a bridge between patients attending the Adult or Pediatric AIDS Outpatient Clinics and the scientific research community. The Center serves as a hub for clinical, basic and social science investigators. Research Information The Clinical Core provides services that foster the interface between basic science, clinical, behavioral, and epidemiologic investigators and HIV-infected patients. Clinical Core efforts continue to be organized into four key services: 1. The Comprehensive Specimen Repository Service is utilized by HIV investigators representing multiple research disciplines to ensure efficient collection, processing, storage, quality assurance tracking, distribution, and shipping of clinical specimens obtained from well-characterized patients. The overall level of repository activity has been steady over several years, processing and storing or shipping approximately ten thousand blood and tissue specimens annually for diverse investigational programs within UAB as well as for collaborators from other institutions. 2. The Computerized Clinical Database and Informatics Service promotes efficient identification of potential subjects for clinical trial recruitment; provides key clinical and laboratory information for translational research projects; and enables linkage of different types of data (for example, integration of information related to adherence, quality of life, safety, treatment responses, clinical outcomes, and the costs of care). During 2005, our customized electronic medical record (EMR) system was fully implemented and is now utilized for all aspects of routine patient care as well as clinical and translational research. 3. The CFAR Clinical Core has continued to expand its Research Training Services, both to maintain ongoing medical education for current healthcare workers and to initiate training for both foreign and domestic researchers. One of the key goals of the Clinical Core is to assist international collaborators and staff with learning about the conduct of vaccine and therapeutic trials and other clinical research, good clinical practice, human subjects training, and institutional review board credentialing. A variety of healthcare workers, nurses, and clinicians regularly rotate through our clinical services and research programs before moving to other parts of the world to initiate or carry on treatment and research programs for HIV-infected or at risk populations. Dr. Michael Kimmerling plays a major leadership role in these CFAR international training efforts. This same infrastructure and organization enables us to coordinate the ongoing training of a variety of local clinicians-in-training and a variety of healthcare-associated workers and students. 4. A new service recently initiated by the Clinical Core is the High Risk Volunteer Cohorts Service. The goal of these efforts is to identify individuals who are at high risk of acquiring HIV infection and enroll them into counseling and testing interventions. Specimens and clinical information derived from individuals who do or do not acquire HIV infection over long-term follow-up using these strategies are then available for a variety of behavioral, epidemiological, and clinical research efforts. Two different Birmingham area research cohorts supported through the CFAR Clinical Core have been actively recruiting volunteers over the past year – a Discordant Couples Cohort and a High Risk Individual Cohort. Both cohorts contribute to our growing community outreach and education efforts while optimizing the earliest possible identification of new cases for treatment or secondary prevention interventions. The cohort also provides identification of potential research subjects for a variety of clinical research efforts, particularly the AIEDRP studies for acute and early infections, vaccine and HPTN studies, and ACTG trials for treatmentnaïve, newly-diagnosed individuals. The repository of specimens and clinical information on discordant couples provides information about both the potential donor and recipient, crucial for studies related to vaccine development, prevention strategies including topical microbicides, behavioral studies, and translational research related to immunogenetics, mucosal transmission and early pathogenesis events. Services and Fees Investigators who wish to obtain specimens from the Clinical Repository are assessed a processing fee, which is dependent upon the specimen type requested. For more information on prices and/or obtaining specimens, please send an email to czhang@uab.edu. Projects involving the Computerized Database/Informatics service may be available for free or may be subject to a fee if they involve substantial staff time and resources. For more information on this service, please send an email to Dr. Michael Saag at msaag@uab.edu. Coordination and assistance with research training efforts is generally provided without fees. Please contact Dr. Michael Kilby at mkilby@uab.edu with any questions. Questions or research interest in the High Risk Volunteer Cohorts may also be directed to Dr. Kilby. Contact Information Director: J. Michael Kilby, MD Email: mkilby@uab.edu Phone: 205-975-1937 or 205-934-1917 Web Site: http://main.uab.edu/cfar/Templates/Inner.aspx?pid=16526 Approved by: J. Michael Kilby, MD, Director Date: February 7, 2007 Click here to go back to the list of Core Facilities.