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.
Joseph J. Eron, MD
Core Director
Dr. Eron is Chief of the Division of Infectious Diseases, 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 30 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
CB #7030
Chapel Hill, NC
joseph_eron@med.unc.edu
Fax: 919-966-6714
Office Phone: 919-843-2722
Claire Farel, MD, MPH
Core Co-Director
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
CB #7030
Chapel Hill, NC
claire_farel@med.unc.edu
Fax: 919-966-6714
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 20 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
napravs@med.unc.edu
Fax: 919-966-6714
Office Phone: 919-966-3875
David Wohl, MD
Investigator
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 25 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
CB #7030
Chapel Hill, NC
david_wohl@med.unc.edu
Fax: 919-966-6714
Office Phone: 919-843-2723
Kuo-Ping Li, PhD
Data Manager
Dr. Li graduated from UNC-CH with a doctorate degree in Physics. He is skilled in building and maintaining databases, data management, analysis and programming, including SAS, SQL and web development applications. Dr. Li manages the UNC CFAR HIV Clinical Cohort database and management systems. He provides assistance with data requests from existing resources and data sources. Dr. Li maintains data collection and management systems for investigators and provides programming and information technology support. Dr. Li has joined the UNC CFAR in 2019.
130 Mason Farm Road
CB #7030
Chapel Hill, NC
kpli@email.unc.edu
Fax: 919-966-6714
Office Phone: 919-843-6531
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.
CB# 7215
Chapel Hill, NC
tania_caravella@med.unc.edu
Office Phone: 919-843-5301
Cheryl Hendrickson, BS
Regulatory Coordinator
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
CB #7030
Chapel Hill, NC
cheryl_hendrickson@med.unc.edu
Office Phone: 919-843-2541
Amy Durr, MSN, FNP
Project Manager
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.
130 Mason Farm Road
CB #7030
Chapel Hill, NC
aldurr@med.unc.edu
Fax: 919-966-6714
Office Phone: 919-843-5174
JoAnn Kuruc BSN, MSN
Clinical Program Director
Ms. Kuruc is an experienced clinical trial nurse and project manager with the UNC Institute for Global Health and Infectious Diseases. She obtained her BSN from Villanova University and MSN from UNC Charlotte. Ms. Kuruc is the clinical program director for ongoing HIV clinical and translational research programs including the UNC Delaney Collaboratory of AIDS Researchers for Eradication (CARE), the UNC Clinical Trials Unit and other grant and industry funded projects. Ms. Kuruc assists CFAR translational investigators with developing more complex interventional trials, including protocols that require invasive specimen collection. She manages the logistics for cervical and vaginal fluids and biopsies, gut-associated lymphoid tissue (GALT) via rectal and ileal biopsies, fine needle lymph node aspirates, lumbar punctures and bone marrow biopsies.
Deana Agil, MR
Research Assistant
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.
130 Mason Farm Road
CB #7030
Chapel Hill, NC
deana_agil@med.unc.edu
Fax: 919-966-6714
Office Phone: 919-966-6216
LaToya Mullen, MPH, CHES
Behavioral Interventionist
LaToya Mullen, MPH, CHES® is the Behavioral Interventionist working on the STOMP Study. LaToya moved to North Carolina in 2016 from Akron, Ohio and she notes “it’s the best decision she’s ever made!” She enjoys crocheting, volunteering, traveling and taking frequent trips to Target 😊.
130 Mason Farm Road
CB #7030
Chapel Hill, NC
latoya_mullen@med.unc.edu
Lindsay Browne, BA
Research Assistant
Ms. Browne received her BA in Government and Public Health from William & Mary in 2019. She provides assistance with data collection and study enrollment. Her past experience is in social epidemiology, with a focus on the intersections of housing insecurity and health.
130 Mason Farm Road
CB #7030
Chapel Hill, NC
lindsay_browne@med.unc.edu
Dylan Brown, BS
Research Assistant
Dylan graduated from UNC Chapel Hill in 2020 with degrees in Biology and Music. He assists the clinical core with data collection and patient screening. He has been with the UNC CFAR since 2020.
Kendall Conder, BA
Research Assistant
Kendall received her BA in Global Studies with a concentration in Global Health and Latin American Studies from the University of North Carolina in 2019. She assists with data collection and study enrollment. She has been with the UNC CFAR since 2020.
Nazneen Khan, BA
Research Assistant
Nazneen Khan received her BA in Public Policy with a Concentration in Health and Bioethics in addition to a minor in Medical Anthropology as they intersect with her passion for Public Health from UNC-Chapel Hill. She provides assistance in data collection and study enrollment. She has been with UNC CFAR since 2020.
Christopher Lopez, BS/BA
Research Assistant
Chris graduated from UNC with degrees in Biology and Anthropology in 2018. He loves to play tennis, listen to the same 12 songs on Spotify, and binge shows on HBO. He intends to pursue an MPH in epidemiology to promote racial and health equity through the means of public health. He provides assistance in data collection and study enrollment. He has been with UNC CFAR since 2020.
Amanda Moy, BS
Research Technician
Amanda graduated from the University of Maryland, Baltimore County in 2020 with a BS in Biological Sciences and a BS in Psychology with a specialization in Biopsychology. In the future, she hopes to pursue a career in pathology and medical genetics. When she has free time, she enjoys tutoring, sketching, and spending time with all of her pets. Amanda provides assistance with chart abstraction and data collection. She has been with the UNC CFAR since 2021.
Tia Morgan, MSc
Clinical Research Screener
Tia Maree’ Morgan recently completed her second Masters of Science focused on HPV from the Microbiology and Immunology Department at the University of North Carolina Chapel Hill. Prior to UNC-CH She received her B. S. -Biology from Shaw University in 2011 and a Masters of Science (Studied Neisseria Gonorrhoeae) from North Carolina Central University in 2014. Through her journey she has learned 3 things 1) Go after what you want no matter how bumpy the road is, 2) Things do not always go as planned, but in everything there is a lesson. Take perspective and keep moving forward, and 3) Dreams or goals change or develop further. Go with it. It doesn’t mean you are giving up, just means your growing and changing. She aspires of opening a specialized community and health center. Outside of work she does photography, music, and giving back to the community. She has a zest and passion to understand infectious diseases and help those most affected. She is excited to be a part of an amazing team and have the opportunity to begin her clinical research journey.
Services
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.
Database Management
-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.
Mentoring
-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.
Referrals
-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.
Past Projects
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 |
Publications
Williams-Nguyen J, Hawes SE, Nance RM, Lindstrom S, Heckbert SR, Kim HN, Mathews WC, Cachay ER, Budoff M, Hurt CB, Hunt PW, Geng E, Moore RD, Mugavero MJ, Peter I, Kitahata MM, Saag MS, Crane HM, Delaney JA. Association Between Chronic Hepatitis C Virus Infection and Myocardial Infarction Among People Living with HIV in the United States. Am J Epidemiol. 2020;189(6):554-63. PMCID Number: Journal In Process.
Eron JJ, Orkin C, Cunningham D, Pulido F, Post FA, De Wit S, Lathouwers E, Hufkens V, Jezorwski J, Petrovic R, Brown K, Van Landuyt E, Opsomer M, EMERALD study group. Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1. Antiviral Res. 2019;170:104543. PMCID Number: Journal In Process. PMC6252401
Orkin C, Molina J-M, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M, EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. The Lancet HIV. 2018;5(1):e23-e34. PMCID Number: PMC5631339.