Research Project
10304586
Project Summary Core D ? Clinical and Behavioral Services Core The Clinical and Behavioral Services Core D furthers the scientific mission of the Case Western Reserve University Center for Excellence on the Impact of Substance Use on HIV by providing a uniform, broadly available resource to gain access to subjects, specimens, and collected data for basic, translational, clinical, epidemiological, behavioral, and psychosocial studies of HIV disease. Currently, the Core has a searchable registry with longitudinal history of virtually all HIV-infected patients followed in the MetroHealth System (MHS) ID clinic, the largest HIV provider in Northeast Ohio, and will establish a biorepository linked to this clinical data. Core D will enable investigators to conduct studies that require access to populations that are typically difficult to reach, recruit, and retain. The Database will leverage the robust electronic health record (EHR) that has been in place since 1999 at MHS. The EHR has embedded search tools to (i) enable population health research, (ii) identify subjects for research and registries, (iii) track populations, and (iv) retrieve extensive clinical information with data extending back to 1999. The Specimen Repository will be linked to the Database and offers researchers ready access to stored samples complete with comprehensive, longitudinal, clinical, patient reported outcomes, behavioral, and laboratory data. Core D will leverage existing studies of patients who use illicit substances to develop a comprehensive database and specimen repository of persons with substance use disorder and HIV and then expand to include HIV-negative at-risk for HIV substance using individuals. The linked repository will include a robust expansive program for longitudinal semi-annual collection of peripheral blood mononuclear cells, plasma, serum, stool, rectal swabs, vaginal swabs, and urine. The repository will also collect and store tonsillar tissue, CSF, and colonic biopsies. Participants will receive client centered assistance to treat addiction from staff trained to use motivational interviewing. Core D will integrate public and mental health activities in Northeast Ohio regarding persons with HIV and Substance Use Disorder through clinical and community outreach with our neighboring public and mental health organizations, that include urban (Cleveland), suburban (Cuyahoga), and suburban/rural (Lorain) populations. Finally, Core D leadership will assist investigators in formulating research questions that take full advantage of the clinical Database and specimen Repository, while avoiding pitfalls and potential biases that result from incomplete understanding of the data structure, patient-related data, and patient characteristics.
