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The Clinical Core has been a cornerstone of the UAB CFAR for over two decades, enhancing all aspects of human HIV research. The importance and future direction of the Clinical Core is as dynamic as it has ever been, meeting changing investigator needs, addressing new knowledge gaps and accompanying shifts in the scientific agenda, and studying the evolving HIV epidemic. Enhanced synergies within the Core allows for more timely and seamless service delivery, and for service expansion to allow for “on demand” specimen capture and prospective research recruitment, study coordination and protocol implementation to a record number of investigators.

We provide easy access to comprehensive clinical services, resources and expertise supporting basic science, behavioral, epidemiological, translational, clinical and public health research. Clinical Research Training Services are provided at all levels including the 1917 Clinic Cohort which is an opportunity for investigators from across campus to meet to discuss HIV research. The Clinical Core is rapidly adapting and instituting innovative and expanded services in response to user needs and to support the overarching UAB CFAR scientific mission and pillars of prevention, drug discovery, pathogenesis, and the natural history of HIV in the modern treatment era.

The CFAR Biostatistics and Analysis Services, a component of the Clinical Core,  provide statistical, epidemiologic, health services research and bioinformatics support to CFAR investigators for the development of research proposals including data management and quality control with analyses. This is accomplished by a collaborative team of investigators who provide input on study design and analyses as well as logistical issues and problems impacting the quality and integrity of studies in addition to advice on literature interpretation, assessment of new methodologies and support for studying unique aspects of HIV in the US Deep South. The range of studies include pilot data and phase I clinical trials for drug discovery to pathogenesis, prevention (both primary and secondary) and the "new" natural history of HIV infection in the treatment era. The type of studies include both genetic and non-genetic such as observational designs, clinical research, health services research, health economic modeling and other evaluations such as mixed treatment comparisons, indirect treatment comparisons and causal modeling.

Clinical Core

Aims

Clinical Core Aims

Aim 1: To provide Computerized Database and Informatics Services along with expertise in management and quality assurance of complex, interactive data derived from multiple electronic data sources, generation of analysis-ready datasets, and development of health informatics software.

Aim 2: To provide a comprehensive and efficient Specimen Repository obtained from well-characterized patients along with expertise in identification of study participants to achieve investigator objectives, and ready provision and processing of existing and ad hoc biological samples.

Aim 3. To provide Study Coordination, Recruitment, and Implementation Services along with the expertise to properly staff and prepare logistics for successful performance of prospective observational and point-of-care interventional studies within the UAB 1917 HIV Clinic.

Aim 4. To provide and coordinate Clinical and Research Education and Training Services along with expertise in matching trainee needs with available services and resources offered by Core C.


Database & Informatics


Database & Informatics Services

The Clinical Core provides a Computerized Database and Informatics Service to store and access complex, interactive data to assist with study design and to conduct appropriate data analysis.
• Assists young and established UAB investigators as well as outside researchers to provide data queries and identification of potential research subjects who meet clinical or scientific criteria for retrospective or prospective translational research studies.
• Collaborates with other CFARs and institutions in the form of computerized informatics and biostatistics expertise to assist with launching their own databases.
• Consults on design of database management plans for individual projects.
• Consults on the operation of project-specific systems.
• Assists or consults in design and creation of data collection instruments and forms.
• Database coordination with other Cores and Centers.
• Prepares datasets suitable for statistical analysis.


Specimen Repository


Specimen Repository Services

The Clinical Core maintains and provides patient samples from a comprehensive and efficient Specimen Repository obtained from well-characterized patients for collaborative investigations involving multiple research disciplines. Contact the Clinical Core to have samples processed or obtain samples for research purposes. The Core also provides samples to other CFARs and outside investigators to aid scientific research.

Types of existing specimens available:
• Fresh blood
• Plasma
• Serum
• Peripheral blood mononuclear cells
• Mucosal secretions
• Mucosal biopsies, lymph node biopsies, skin biopsies

Types of services available:
• Provides Identification and collection of clinical samples.
• Provides access to stored samples from well characterized patients.
• Provides access to expertise in the development and implementation of HIV vaccine trials.
• Provides plasmaphoresis and leukophoresis to CFAR members and network organizations in order to provide a greater volume of samples from a few patients with unique characteristics (e.g., long term nonprogressors).

Biostatistics


Biostatistics and Analysis Services
The Biostatistics and Analysis Component of the Clinical Core is a centralized resource to provide access to statistical expertise and data management to support research programs and projects conducted by CFAR members. The value added to the CFAR scientific mission includes: Statistical design of experiments to efficiently address scientific questions; Sample size estimation to assist investigators in determining study feasibility; Data analysis of preliminary data to be used in hypothesis generation; Secondary data analyses of databases; Guidance in structuring databases to ensure that required data to address scientific issues can be easily retrieved and analyzed; Availability of software resources for statistical and data management purposes. Acquisition of some software is costly, but our experts can utilize software across CFAR members and, in some cases, across other applications, to minimize the costs.

Research Coordination


Research Coordination Services

The Clinical Core offers Research Coordination, Recruitment and Implementation Services including support with recruitment, enrollment, protocol design development and implementation. Core personnel are available to assist with regulatory and study coordinator support, data and specimen collection, web-based tracking and data entry, database design and data management. Ongoing collaborations exist with the CFAR Network of Integrated Clinical Systems and other national and international cohort studies.
• Reviews and critiques existing / draft protocols.
• Collaborates in development of study design (experimental and observational).
• Assists with IRB application.
• Facilitates access to expertise in multiple sub-disciplines of HIV research including hepatology, cardiology, neurology, nephrology, hematology/oncology, obstetrics and gynecology, and psychiatry.
• Consults on study implementation, operations, and monitoring adherence to protocol.
• Assists with data collection or identification and assessment of appropriateness to research hypotheses.
• Develops clinically appropriate analysis plans and strategies.
• Assists with budget planning for grant proposals, estimation of costs.
• Provides letters of support, biosketch, background information, other-support pages.
• Assists with clinical epidemiologic analytic computations.
• Provides interpretive analyses of clinical, laboratory and basic science results.
• Provides collaborative preparation of publications and presentations.
• Progress report check ins with investigators (proactive tracking form)

Education


Education and Training Services

The Clinical Core provides Clinical and Research Education and Training Services providing coordination of training sessions including 1917 Clinic Cohort Meetings and 1917 Clinic Provider meetings. Additional services including research consultation and regulatory training are provided to a wide range of trainees.
• Training ID Fellows
• IPE (inter-professional education)
• Weekly Cohort Research Roundtable Interactive Discussions
• Monthly Provider meetings
• Monthly 1917 Clinic meetings
• 1917 CQI and AL Regional Quality Group
• Community Partner Collaborative Education
• Clinical Care Team Education Services

Contact


Clinical Core
Director
Michael Mugavero, MD, MHSC
Email: mmugavero@uab.edu  
Co-Director (Database & Informatics)
Greer A. Burkholder, MD, MSPH 
Email: gburkhol@uab.edu 
Co-Director(Specimen Repository)
Sonya L. Heath, MD 
Email: heaths@uab.edu
 
Clinical Core Coordinator
Sarah Dougherty
Email: sarahdougherty@uabmc.edu 

Database & Informatics Coordinator
Alfredo Guzman, MEng
Email: aguzman@uab.edu

Specimen Repository Coordinator
Kamellia Safavy, MS
Email: ksafavy@uab.edu
  University of Alabama at Birmingham
Community Care Building (CCB)
908 20th Street South
Birmingham AL 35294-2050
205-975-5667
 

Biostatistics & Analysis Assistance
Component Leader
Dustin M Long, PhD
Email: dmlong@uab.edu 
Other Leadership
Andy Westfall, MS
Email: AndyW@uab.edu 
 Other Leadership
Ashutosh Tamhane, MD, PhD
Email: tamhane@uab.edu 
University of Alabama at Birmingham
Bevill Biomedical Building
CFAR Offices/RISC Suite
2nd Floor
Rooms 206 & 256