The Clinical Core offers 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.
The Clinical Core maintains the UNC CFAR HIV Clinical Cohort (UCHCC), with adjudicated clinical outcomes data and samples, HIV sequences, behavioral surveys and patient reported outcomes. Ongoing collaborations exist with the CFAR Network of Integrated Clinical Systems and other national and international cohort studies. For more information visit the UCHCC website.
The Clinical Core holds regular trainings for research professionals. Please access our open source training materials here.
Please contact the UNC CFAR Clinical Core with new requests by e-mailing us here.
The Clinical Core relies on a comprehensive infrastructure, experienced leadership and diverse personnel resources to enhance all aspects of HIV research encompassing HIV-infected and HIV-uninfected patient and participant interactions, their specimens and data. The Clinical Core’s Specific Aims are:
Provision of comprehensive clinical services essential to HIV research.
Access to resources, expertise and leadership fostering and supporting new and ongoing HIV initiatives and goals.
Collaboration locally, nationally and internationally with HIV networks, cohorts and research groups.
Training and mentoring, organizing work in progress and research group seminars and grand rounds.
Infrastructure and resource innovation informed by ongoing evaluation and strategic planning.
Joseph J. Eron, MD
Dr. Eron is Professor in the Division of Infectious Diseases, School of Medicine, and Adjunct Professor in the Department of Epidemiology, Gillings School of Global Public Health. Dr. Eron is an active HIV clinician and has over 20 years of experience in translational, clinical and epidemiologic research. He leads the UNC HIV clinical trials unit which includes local and international sites participating in all five NIH-sponsored HIV treatment and prevention networks. Dr. Eron oversees the UNC CFAR HIV Clinical Cohort study and provides leadership to national and international cohorts, including the CFAR Network of Integrated Systems, the North American AIDS Cohort Collaboration on Research and Design, and the Women’s Interagency HIV Study. He provides assistance with all aspects of undertaking basic science, interventional and observational research. Dr. Eron has been the UNC CFAR Clinical Core Director since 1998.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 919-843-2722
Claire Farel, MD, MPH
Dr. Farel is Assistant Professor in the Division of Infectious Diseases, School of Medicine, and Medical Director of the UNC Infectious Diseases and HIV Clinic. She is an active HIV clinician providing care at UNC and UNC affiliated clinics. Dr. Farel leads the UNC Ryan White Part B and C projects. Her research focuses on challenges along the HIV care continuum including among women and incarcerated individuals. She provides assistance with recruitment of HIV-infected patients to translational and clinical projects and assists the implementation of clinic based interventional and observational studies, including the UNC CFAR HIV Clinical Cohort study. Dr. Farel has been with the UNC CFAR since 2014.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 919-843-3659
Sonia Napravnik, PhD
Associate Core Director
Dr. Napravnik is Research Associate Professor in the Division of Infectious Diseases, School of Medicine, and the Department of Epidemiology, Gillings School of Global Public Health. Dr. Napravnik has over 15 years of experience in HIV clinical and epidemiologic research, with a focus on analytic methods in using observational clinical data. She oversees the UNC CFAR HIV Clinical Cohort study and provides leadership to clinical cohort collaborations, including the CFAR Network of Integrated Systems and the North American AIDS Cohort Collaboration on Research and Design. She provides assistance with study design, implementation and analysis to translational and clinical investigators. Dr. Napravnik has been with the UNC CFAR since 2000.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 919-966-3875
David Wohl, MD
Dr. Wohl is Associate Professor in the Division of Infectious Diseases, School of Medicine, Co-Director of HIV Services for the North Carolina Department of Corrections and Director of the North Carolina AIDS Training and Education Center. Dr. Wohl maintains a large HIV continuity clinic at UNC and sees patients at the North Carolina state prison. He has over 15 years of experience leading multiple-site clinical research investigations including complex HIV treatment clinical trials, pathogenesis focused collaborative studies and prison based research. Dr. Wohl is Site Leader of the HIV Network UNC Clinical Research site in Chapel Hill and provides leadership within the AIDS Clinical Trials Group and HIV Prevention Trials Network. He provides assistance with prison based research, clinical research on HIV complications and HIV prevention strategies. Dr. Wohl has been with the UNC CFAR since 2000.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 919-843-2723
Oksana Zakharova, MS
Ms. Zakharova is the Clinical Core Manager. She has over 10 years of experience with electronic health record systems, clinical outcome adjudications, in-person interview techniques, specimen collection, and clinical and translation protocol implementation. Ms. Zakharova manages the Clinical Core’s daily operations and project activities, and links investigators with CFAR resources and services. She provides assistance with recruitment, data and specimen collection, and requests for services. Ms. Zakharova has been with the UNC CFAR since 2004.
Kaitlyn Michalak, BS
Ms. Michalak graduated from UNC-CH with a dual degree in Information Science and Music. She is skilled in database development, data management and programming, including SAS, SQL and web development applications. Ms. Michalak manages the UNC CFAR HIV Clinical Cohort database and management systems. She provides assistance with data requests from existing resources and data sources. Ms. Michalak maintains data collection and management systems for investigators and provides programming and information technology support. Ms. Michalak has been with the UNC CFAR since 2015.
Tania Caravella, MPH
Regulatory and Ethics Consultant
Ms. Caravella is the Director of Regulatory Affairs for the UNC Institute for Global Health and Infectious Diseases and serves as the Regulatory and Ethics Consultant for the International Core of the UNC CFAR. She has an MPH in Epidemiology and Biostatistics from Boston University and a BA from Duke University. She has 20 years of experience working in the pharmaceutical industry and in academic medical centers. Currently, Ms. Caravella oversees the regulatory affairs for 400 studies worldwide, providing support with both international and domestic IRBs, and works with other regulatory authorities including the FDA and equivalent bodies in collaborating countries. She assists investigators and sponsors in the regulatory approval process, provides GCP and Human Subjects Protection training for staff, and serves as a resource for sound ethical research in human subjects. She has worked with researchers in 10 countries such as Malawi, Zambia, Vietnam, South Africa, Cameroon, China, and Russia.
Chapel Hill, NC
Office Phone: 919-843-5301
Cheryl Hendrickson, BS
Ms. Hendrickson is a regulatory coordinator with the UNC Institute of Global Health and Infectious Diseases. She provides assistance with completing and submitting IRB applications, including drafting informed consent and HIPAA forms, and maintaining IRB approvals. She has been with the UNC CFAR since 2013.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 919-843-2541
Heather Prince, MPA, PA-C
Ms. Prince is a board certified specialized surgical Physician Assistant with over 16 years of patient care and clinical trials experience, including HIV clinical, translational and pharmacologic research. She provides assistance with more complex interventional trials and protocols that require invasive specimen collection. She has been with the UNC CFAR since 2008.
Amy Durr, MSN, FNP
Ms. Durr is a Nurse Practitioner in the UNC Infectious Diseases and HIV Clinic and manages UNC Ryan White projects. She has expertise in evaluating and monitoring HIV clinical care provision, including developing and implementing continuous quality improvement and care retention initiatives. She provides assistance with implementing clinic based HIV studies. She has worked with the UNC CFAR since 2001.
Katherine Barley, BA
Ms. Barley is a Clinical Research Assistant who is based in the UNC Infectious Diseases and HIV Clinic. She assists with recruitment into HIV translational, clinical, interventional and observational research studies. Ms. Barley also provides assistance with obtaining informed consent and clinic based data collection administration.
130 Mason Farm Road
Chapel Hill, NC
Office Phone: 984-974-0156
Thibaut Davy-Méndez, MSPH
Graduate Research Assistant
Mr. Davy-Méndez is a predoctoral trainee in the Department of Epidemiology, Gillings School of Global Public Health. He has substantial experience with HIV clinical data collection and data management. Mr. Davy-Méndez provides assistance with data and specimen requests, including those from the UNC CFAR HIV Clinical Cohort study. He has been with the UNC CFAR since 2013.
Ami Shiddapur, BS
Ms. Shiddapur received her BS degree in biology with a minor in chemistry from UNC-Chapel Hill in 2018. She has experience working in laboratory settings. Ms. Shiddapur provides assistance with data collection and management. She has been with the UNC CFAR since 2018.
Laura Ruegsegger, BS
Ms. Ruegsegger graduated from Ohio State University with a degree in public health in 2017. She has contributed to several projects in the field of infectious diseases in Malawi and has experience in data collection and in-person interviews. Ms. Ruegsegger provides assistance with data collection and cleaning and surveying administration. She has been with the UNC CFAR since 2018.
Deana Agil, MR
Ms. Agil received her BS in Biochemistry from UNC Chapel Hill in 2014 and Master’s degree in Physiology from NC State University in 2017. She has experience in interacting with patients and is knowledgeable of medical terminology. Ms. Agil provides assistance with data collection and project coordination. She has been with the UNC CFAR since 2018.
Training and Tutorial Consultation
-Consultation for clarification, review, or teaching of essential clinical and clinical research concepts.
-Provision of texts and reference literature.
-Provision of on-line resources and reference material for investigators via the www.
-Statistical and epidemiologic software tutorials.
-Classroom teaching and specialized lectures for Schools of Medicine and Public Health.
Planning and Study Design
-Review and critique of existing / draft protocols.
-Assistance in framing of hypotheses, identification of clinical, therapeutic, metabolic, epidemiological, behavioral and disease specific factors.
-Collaborative development of study design (experimental and observational).
-Development of clinically appropriate analysis plans and strategies.
-Justification of proposed methods and strategies, or comparison of methods.
-Assistance with investigational new drug (IND) submissions.
Grant Proposal Support
-Budget planning for grant proposals, estimation of costs.
-Letters of support, biosketch, other-support pages.
-Assistance with obtaining background information.
-Writing of major sections, or collaborative editing of text.
-Critiques of existing grant proposals.
-Assistance with IRB and GCRC application.
Clinical and Translational Interpretive Analysis and Publication
-Assistance with data collection or identification, and assessment of appropriateness to research hypotheses.
-Guidance with model choice and selection of appropriate analytic technique.
-Assistance with clinical epidemiologic analytic computations.
-Interpretive analyses of clinical, laboratory and basic science results.
-Collaborative preparation of publications and presentations.
-Consultation on design of database management plans for individual projects.
-Consultation on the operation and maintenance of project-specific systems.
-Assistance or consultation in design and creation of data collection instruments and forms.
-Access to UNC CFAR HIV Clinical Cohort (UCHCC) to assess subject availability and provide reliable background information.
-Access to the UCHCC for observational clinical based research.
-Database coordination with other Cores and Centers.
-Preparation of datasets suitable for statistical analysis.
Coordination and Project Management
-Consultation on study implementation, operations, and monitoring adherence to protocol.
-Consultation regarding communication, coordination, and timelines in large studies.
Clinical and Translational Research Development and Implementation
-Subject identification, recruitment and consent.
-Identification and collection of clinical samples.
-Access to stored samples from well characterized patients.
-Assistance with study design and development.
-Conducting or assisting in the conduct of clinical research trials.
-Access to expertise in multiple sub-disciplines of HIV research including oral medicine, hepatology, cardiology, neurology, nephrology, hematology/oncology, obstetrics and gynecology, and psychiatry.
-Access to expertise in the development and implementation of HIV vaccine trials.
-Publish and present expository papers for AIDS researchers.
-Guidance and consultation to new CFAR members.
-Mentoring investigators with CFAR Developmental Awards or NIH K Awards.
-Mentoring dissertation or masters thesis students, infectious disease fellows, medical students, and physician extender students working on a CFAR project.
-Mentoring of international clinical and laboratory researchers.
AIDS Research Communication
-Monthly collaborative research meeting.
-Annual World AIDS Day HIV/AIDS symposium.
-Annual Community Forum for HIV infected patients.
-Identification and recruitment of appropriate professional clinical and basic scientists available to assist new or ongoing projects.
-Successful referral and follow-up with monitoring and verification of client satisfaction.
Over the past several years the Clinical core has provided comprehensive services (please see services page) to diverse grants funded through the seven NIH institutes that support the CFAR. Selected examples of grants supported are shown below. We further include examples of grants funded through other NIH institutes and through North Carolina State and University of North Carolina Sources.
|Sponsor||Award Supported||Award Title|
|NIAID||U01 AI046749||HIV Prevention Trials Network Leadership Group (HPTN)|
|NIAID||U19 AI31496||Acute HIV and STDs in Malawi|
|NIAID||T32 AI007151||Infectious Disease Pathogenesis Research Training|
|NIAID||U01 AI069243||UNC AIDS Clinical Trials Unit|
|NIAID||R01 AI66920||Effect of Earlier HAART on HIV Disease Progression and Survival|
|NIAID||UO1 AI067854 (CHAVI)||Viral and Host determinants of HIV-1 transmission, persistence and containment in natural human infection: Application to AIDS vaccine design|
|NIAID||R03 AI068484||Antiretroviral treatment strategies with optional switching times|
|NIAID||K23 AI54980||Antiretroviral Pharmacology in the Genital Tract|
|NIAID||R34 AI087065||Preventing HIV infection in women: targeting antiretrovirals to mucosal tissues|
|NIAID||R01 AI045297||Repression of HIV Transcription-A Pathway to Quiescence|
|NIAID||U19 AI082608||Pilot studies to disrupt persistent HIV infection in man|
|NIAID||R34 AI084553||The in vivo effect of HDAC inhibitors on HIV gene expression in resting CD4+ T CE|
|NIAID||R01 AI83059 (MP3)||Acute HIV Infection – A key link for transmission prevention|
|NIAID||U01 AI 069918||North American AIDS Cohort Collaboration Research and Design|
|NIAID||R21 AI087360||Viremia Copy-Years: Measuring the Effect of Cumulative HIV Burden on Outcomes|
|NIAID||K23 AI077355||Sex, Aging and Antiretroviral Pharmacology|
|NIAID||R24 AI067039||CFAR-Network of Integrated Clinical Sciences, CNICS|
|NIAID||R01 AI044667||Biological Properties of HIV-1 V3 Evolutionary Variants|
|NIAID||R01 AI50845||Role of Fitness in HIV Protease Inhibitor Resistance|
|NIAID||U01 AI048005||HIV Prevention Trials Unit ? Malawi|
|NIAID||U01 AI068619||HIV prevention trials network coordinating and operations center|
|NCI||U01 CA121947||AIDS Malignancy clinical trials consortium|
|NHLBI||R01 HL74814||Fat Redistribution and Metabolic Change in HIV Infection (FRAM)|
|NICHD||K24 HD059358||Mentoring junior faculty – The minority imperative|
|NICHD||K12 HD01441||Building Interdisciplinary Research Careers in Women’s Health|
|NICHD||K99 HD063961||Pregnancy and response to antiretroviral therapy in South Africa|
|NIMH||K23 MH075718||Internet based HIV prevention for students at historically black colleges|
|NIMH||R01 MH086362||Improving HAART adherence in depressed HIV clinic patients|
|FIC||D43 TW01039||AIDS International Training and Research Program|
|FIC||D43 TW06568||Infectious Disease Epidemiology Training for Malawians|
|NEI||U10 EY08057||Longitudinal Study of the Ocular Complications of AIDS|
|NIAG||R01 AG024379||The role of p16ink4a in mammalian aging|
|NIDCR||BRS-ACURE-Q-06-00160-T002||Oral HIV AIDS Research Alliance|
|NIDDK||R01 DK049381||HIV in Semen-Effects of STDs|
|NINDS||R01 NS062754||Effect of HIV infection and antiretroviral therapy on cerebral autoregulation|
|AHRQ||R01 HS018731||Comparative safety of antiretrovirals among HIV-infected patients: minimizing coronary heart disease outcomes|
|NC DHHS||N/A||Creating links between HIV testing, care and prevention|
|NC DHHS||N/A||CD4 And RNA Testing With HIV Diagnoses in North Carolina – Program Evaluation of The Card to Care Program|
|NC Dean’s Project||N/A||Invest for the Future. The North Carolina Integrated response to HIV/AIDS prevention and treatment|
|UNC LCCC Award||N/A||Understanding the Epidemiology and Pathobiology of Cancer in HIV-Infected Individuals in North Carolina|
|NC TRACS||N/A||The Molecular Epidemiology of HIV infected Latinos in NC|
|NC TRACS||N/A||Extracellular and Intracellular Atripla Pharmacokinetics in the Aging HIV-Infected Population|
|NC TRACS||N/A||Investigation of cardiovascular disease among patients with HIV|
|NC TRACS||N/A||Spatial Epidemiology, Risk Behavior, and HIV Resistance in North Carolina|