Adherence to HCV Treatment in HCV and HCV/HIV Patients

描述（由申请人提供）：NIMH指导的以患者为导向的职业发展奖（K23）的申请，题为“坚持HCV和HCV/HIV患者的HCV治疗”，旨在将主要研究者（PI），临床心理学家，发展成为一名独立的研究者，对患有精神病和物质使用障碍的非依从性医学疾病患者进行研究。PI的短期职业目标包括获得（1）HCV和HIV感染的诊断和治疗知识，（2）依从性测量和不依从的生物学后果的知识，（3）药物滥用相关问题和HIV/HCV和药物滥用的神经认知方面的培训（4）研究方法学，统计学，赠款写作（5）关于（前）注射吸毒者研究的公共卫生和政策方面的培训，（6）进行伦理研究的培训，（7）管理结构化精神病学访谈时间表的培训。PI的长期目标包括研究共病医学和精神疾病对药物治疗依从性的影响，特别是HCV和HCV/HIV患者。该研究是一项前瞻性队列研究，其中100名HCV和100名HCV/HIV患者将在开始用聚乙二醇化IFN-α和利巴韦林（PEG-IFN/RBV）治疗HCV之前入组。用PEG-IFN/RBV治疗与许多血液学、身体和神经精神方面的副作用相关，这导致早期治疗中止率高。将在治疗的前24周对200例招募的患者进行随访，以确定抑郁、神经认知功能、药物滥用和治疗自我效能是否与这两组患者的早期治疗中止相关，以及两组患者的早期治疗中止率是否存在差异。这项研究的结果将有重要意义的干预措施的发展，以支持和协助HCV和HCV/HIV患者完成他们的PEG-IFN/RBV治疗过程中。

DESCRIPTION (provided by applicant): This application for an NIMH Mentored Patient-Oriented Career Development Award (K23), titled "Adherence to HCV Treatment in HCV and HCV/HIV Patients," seeks to develop the Principal Investigator (PI), a clinical psychologist, into an independent investigator performing research with nonadherent medically ill patients with comorbid psychiatric and substance use disorders. The short-term career goals of the PI include obtaining (1) knowledge of the diagnosis and treatment of HCV and HIV infections, (2) knowledge of the measurement of adherence and of the biological consequences of non-adherence, (3) training in substance abuse-related issues and neurocognitive aspects of HIV/HCV and substance abuse (4) training in research methodology, statistics, grant writing (5) training in public health and policy aspects of research on (former) injection drug users, (6) training in the conduct of ethical research, (7) training in the administration of structured psychiatric interview schedules. The long-term goals of the PI include conducting research on the impact of comorbid medical and psychiatric conditions on adherence to medical treatment, particularly with HCV and HCV/HIV patients. The research proposed is a prospective cohort study in which 100 HCV and 100 HCV/HIV patients will be enrolled just prior to initiating HCV therapy with pegylated IFN-alfa and ribavirin (PEG-IFN/RBV). Treatment with PEG-IFN/RBV is associated with numerous hematologic, physical, and neuropsychiatric side effects, which lead to high rates of early treatment discontinuation. The 200 recruited patients will be followed for the first 24 weeks of treatment to determine whether depression, neurocognitive functioning, substance abuse and treatment self-efficacy are associated with early treatment discontinuation in these two groups of patients and whether the two groups differ in rates of early treatment discontinuation. The findings of this study will have important implications for the development of interventions to support and assist HCV and HCV/HIV patients in completing their course of PEG-IFN/RBV treatment.