Feasibility of a HCV Decision-Making Intervention among HIV-Infected Adults

描述（由申请人提供）：慢性HCV感染是HIV感染患者的主要问题。如果没有HCV治疗，越来越多的HIV阳性患者将死于终末期肝病或HIV相关并发症，因为由于其肝毒性而无法使用抗逆转录病毒药物。在过去的几年里，对这一人群中HCV治疗的理解取得了重大进展。然而，只有一小部分合并感染的患者接受HCV治疗（约15%）。此外，很少有研究探讨患者的决策与HCV治疗的艾滋病毒合并感染的患者。我们知识的主要差距是如何最好地支持患者，因为他们与医疗保健提供者一起参与HCV治疗决策过程。因此，本II期研究的目的是测试对HIV/HCV合并感染的成年人进行理论推导的群体干预的可行性，以支持积极参与HCV治疗决策。主要目标是：（1）确定招募和保留HIV/HCV合并感染成人样本的可行性，以完成一项方案，该方案涉及随机分配至为期4周的HCV阳性生活技能组干预或常规护理，并完成两次数据收集访谈（在基线和第12周），（2）建立HCV阳性生活技能小组干预对HCV知识，决策冲突，患者-提供者沟通，健康相关的生活质量，症状体验和与卫生保健提供者的接触，（3）探索团体干预对HCV知识，决策冲突，患者-提供者沟通，与卫生保健提供者的接触的影响能力，与健康相关的生活质量和症状体验;（4）描述干预和常规护理的组成部分（通过定性访谈），这是最有用的帮助艾滋病毒/丙型肝炎病毒合并感染的患者参与有关丙型肝炎病毒治疗的决策。将采用混合方法。将50名HIV/HCV合并感染的受试者随机分为两组，分别接受团体干预或常规护理。然后，将使用定性描述方法对10-12名参与者进行定性访谈，以确定支持HCV治疗有效决策的干预和常规护理的最突出部分。我们还将比较两组花费的时间，确定对照条件的变异性，描述开始HCV治疗的受试者数量，并进一步完善干预手册和干预保真度程序，为全面的多中心随机临床试验做准备。 公共卫生相关性：这项可行性研究的结果将提供所需的初步证据，进行一项全面的随机临床试验的干预，旨在改善患者的决策有关HCV治疗艾滋病毒/HCV合并感染的男性和女性。此外，定性访谈的结果将揭示支持在这一脆弱人群中进行HCV治疗决策的最重要问题。

DESCRIPTION (provided by applicant): Chronic HCV infection is a major problem for HIV-infected patients. Without HCV treatment, increasing numbers of HIV positive patients will die either from end stage liver disease or from HIV-related complications because of the inability to use antiretroviral agents due their hepatotoxicity. Major advances in understanding HCV treatment in this population have occurred within the past several years. Yet, only a small proportion of co-infected patients receive HCV treatment (approximately 15%). Moreover, few studies have explored patient decision-making related to HCV treatment in HIV co-infected patients. The major gap in our knowledge is how best to support patients as they engage in the HCV treatment decision making process with their health care provider. Therefore, the purpose of this phase II study is to test the feasibility of conducting a theoretically-derived group intervention with HIV/HCV co-infected adults to support active engagement in HCV treatment decision-making. The primary aims are to: (1) determine the feasibility of recruiting and retaining a sample of HIV/HCV co-infected adults to complete a protocol that involves randomization into the 4-week HCV Positive Life Skills group intervention or usual care and completion of two data collection interviews (at baseline and week 12), (2) establish the preliminary effect size of the HCV Positive Life Skills group intervention on HCV knowledge, decisional conflict, patient-provider communication, health-related quality of life, symptom experience and engagement with health care providers, (3) explore the capacity of the group intervention to influence HCV knowledge, decisional conflict, patient-provider communication, engagement with health care providers, health related quality of life and symptom experience and (4) describe the components of the intervention and usual care (through qualitative interviews) that are most useful for helping HIV/HCV co-infected patients engage in decision- making about HCV treatment. A mixed method approach will be used. 50 HIV/HCV co-infected participants will be randomized equally to receive either the group intervention or usual care. Then qualitative interviews, using qualitative descriptive methods, will be conducted with 10-12 participants to identify the most salient parts of the intervention and usual care that support effective decision-making about HCV treatment. We will also compare the time spent with both groups, identify variability in the control condition, describe the number of subjects who start HCV treatment and further refine the intervention manual and intervention fidelity procedures in preparation for a full scale multi-site randomized clinical trial. PUBLIC HEALTH RELEVANCE: Results of this feasibility study will provide the preliminary evidence needed to conduct a full scale randomized clinical trial of an intervention designed to improve patient decision-making about HCV treatment among HIV/HCV co-infected men and women. In addition, findings from the qualitative interviews will shed light on the most important issues that support decision- making about HCV treatment among this vulnerable population.