Adherence to HCV Treatment in HCV and HCV/HIV Patients

描述（由申请人提供）：这是NIMH指导患者导向职业发展奖（K23）的申请，标题为“HCV和HCV/HIV患者对HCV治疗的依从性”，旨在将临床心理学家首席研究员（PI）培养为独立研究者，对合并精神疾病和药物使用障碍的非依从性医学患者进行研究。PI的短期职业目标包括获得(1)丙型肝炎病毒和艾滋病毒感染的诊断和治疗方面的知识，(2)依从性测量和不依从性的生物学后果方面的知识，(3)药物滥用相关问题和艾滋病毒/丙型肝炎病毒和药物滥用的神经认知方面的培训(4)研究方法、统计、拨款写作方面的培训(5)对（前）注射吸毒者研究的公共卫生和政策方面的培训。(6)进行伦理研究方面的培训；(7)结构化精神病学访谈时间表管理方面的培训。项目的长期目标包括开展关于合并症和精神疾病对坚持治疗的影响的研究，特别是对丙型肝炎病毒和丙型肝炎病毒/艾滋病毒患者。该研究是一项前瞻性队列研究，在开始使用聚乙二醇化ifn - α和利巴韦林（PEG-IFN/RBV）治疗HCV之前，将招募100名HCV和100名HCV/HIV患者。PEG-IFN/RBV治疗与许多血液学、生理和神经精神方面的副作用相关，这导致早期停药的比例很高。200名招募的患者将在治疗的前24周进行随访，以确定这两组患者的抑郁、神经认知功能、药物滥用和治疗自我效能是否与早期停药有关，以及两组患者的早期停药率是否存在差异。这项研究的结果将对开发干预措施以支持和协助HCV和HCV/HIV患者完成PEG-IFN/RBV治疗具有重要意义。

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.