The candidate, a clinical health psychologist, seeks to develop her career into that of an independent investigator performing clinical research with patients with hepatitis C viral (HCV) infection who are undergoing antiviral therapy. The prevalence of mental health disorders in patients with HCV, coupled with the adverse side effects of antiviral therapy, underscores the need for research to develop behavioral programs that can target these issues. The candidate's long-term career goal is to (1) develop psychosocial interventions that enhance HCV treatment outcomes by improving medication-taking adherence and side effect management of neuropsychiatric and other antiviral side effects;and (2) evaluate these interventions in methodologically-robust randomized controlled trials. The mentored research project in this proposal fits into this overarching research program by conducting a pilot feasibility study to adapt and test an intervention to tackle two common challenges of antiviral therapy-depression and nonadherence. The study will be conducted in two phases: first, the Cognitive-Behavioral Treatment for Adherence and Depression (CBT-AD) for HIV intervention will be adapted to meet the needs of HCV patients on antiviral therapy;and second, the new CBT-AD for HCV intervention will be piloted with a sample of patients undergoing antiviral therapy in a small randomized clinical trial to examine feasibility, acceptability, and effect size estimates. The data will demonstrate that conducting group intervention protocols and testing them in clinical trials is feasible and acceptable to patients, and will provide preliminary data to conduct a large, multisite efficacy trial. To acquire the new knowledge and skills to achieve these long-term goals, a four year career and research development plan is proposed. The candidate will receive closely mentored research training by a team of experts in HCV treatment, adherence, behavioral interventions, and randomized clinical trials. Conducting research, under close supervision of mentors, will provide a critical training vehicle for the candidate to develop skills in qualitative methodology, intervention development, and clinical trial conduct. This hands-on training will be augmented by didactics and intensive training workshops led by experts in intervention development and clinical trials. A career advisory board, comprised of national and local experts, has been assembled to provide annual review of the candidate's progress. If funded by the NIDDK, this K23 award will serve as the platform from which to launch a program of research that applies behavioral and psychological knowledge and techniques to improve the treatment outcomes of patients with HCV. The career development, training plan, and research activities proposed by the candidate will be conducted through the UNC Liver Program, a well-established program devoted to exceptional patient care and state-of-the-art clinical research in antiviral therapy for HCV. The candidate is also surrounded by an outstanding institutional environment and resources at UNC to acquire the clinical research and academic skills needed to become an independent and successful, NIH clinical investigator.

Public Health Relevance

Chronic hepatitis C viral (HCV) infection affects nearly 4 million Americans, leading to advanced liver damage and cancer, killing 10,000 Americans each year, and costing our country $700 million dollars each year in healthcare costs. From a public health perspective, it is critical that all persons infected with HCV have the opportunity to successfully complete medical treatment that can cure HCV, and prevent advanced liver problems, deaths, and high healthcare costs. The goal of this project is to develop and test an intervention to treat depressive symptoms and adherence problems, two major challenges to HCV medical treatment, which may, in turn, increase treatment success rates.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23DK089004-03
Application #
8312617
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Podskalny, Judith M,
Project Start
2010-08-01
Project End
2014-07-31
Budget Start
2012-08-01
Budget End
2013-07-31
Support Year
3
Fiscal Year
2012
Total Cost
$132,854
Indirect Cost
$9,841
Name
University of North Carolina Chapel Hill
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
608195277
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
Evon, Donna M; Golin, Carol E; Bonner, Jason E et al. (2015) Adherence during antiviral treatment regimens for chronic hepatitis C: a qualitative study of patient-reported facilitators and barriers. J Clin Gastroenterol 49:e41-50
Evon, D M; Esserman, D E; Howell, M A et al. (2014) Pegylated interferon pharmacokinetics and self-reported depressive symptoms during antiviral treatment for chronic hepatitis C. Pharmacopsychiatry 47:195-201
Evon, Donna M (2014) Incorporating patient-reported outcomes into hepatitis C virus treatment studies. Clin Gastroenterol Hepatol 12:1360-2
Evon, D M; Esserman, D A; Bonner, J E et al. (2013) Adherence to PEG/ribavirin treatment for chronic hepatitis C: prevalence, patterns, and predictors of missed doses and nonpersistence. J Viral Hepat 20:536-49
Bonner, J E; Esserman, D; Evon, D M (2012) Reliability and validity of a self-efficacy instrument for hepatitis C antiviral treatment regimens. J Viral Hepat 19:316-26
Bonner, Jason E; Barritt 4th, A Sidney; Fried, Michael W et al. (2012) Tangible resources for preparing patients for antiviral therapy for chronic hepatitis C. Dig Dis Sci 57:1439-44
Bonner, Jason E; Barritt 4th, A Sidney; Fried, Michael W et al. (2012) Time to rethink antiviral treatment for hepatitis C in patients with coexisting mental health/substance abuse issues. Dig Dis Sci 57:1469-74
Evon, Donna M; Esserman, Denise A; Ramcharran, Darmendra et al. (2011) Social support and clinical outcomes during antiviral therapy for chronic hepatitis C. J Psychosom Res 71:349-56