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

HIV 感染成人中 HCV 决策干预的可行性

• 批准号: 7928003
• 负责人: CAROL A BOVA
• 金额: $ 20.54万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-03-03 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7928003
• 关键词: Address; Adult; Affect; Age; Anti-Retroviral Agents; Appointment; Benefits and Risks; Chronic Disease; Chronic Hepatitis C; Cirrhosis; Clinic; Clinical; Clinical Trials; Cognitive; Communication; Complex; Conflict (Psychology); Conscious; Data; Data Collection; Decision Making; Development; Educational workshop; Enrollment; Evaluation; Feasibility Studies; HIV; HIV-2; Health Personnel; Hepatitis C; Hepatitis C virus; Hepatotoxicity; Incidence; Infection; Intervention; Interview; Knowledge; Life; Light; Liver; Liver Fibrosis; Liver Function Tests; Liver diseases; Manuals; Mental Health; Methods; Minority; Participant; Pathogenesis; Patient Self-Report; Patients; Pilot Projects; Population; Preparation; Primary carcinoma of the liver cells; Procedures; Process; Protocols documentation; Provider; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Role; Sampling; Sampling Studies; Site; Social support; Staging; Symptoms; Testing; Time; Uncertainty; United States; Virus Diseases; Vulnerable Populations; Well in self; Woman; Work; base; clinical care; experience; group intervention; health related quality of life; improved; intervention effect; medical specialties; men; phase 2 study; prevent; prospective; public health relevance; response; skills; therapy design; treatment as usual; uptake; viral RNA

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.

描述(申请人提供)：慢性丙型肝炎病毒感染是艾滋病毒感染者的主要问题。如果不进行丙型肝炎病毒治疗，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，因为它们的肝毒性导致无法使用抗逆转录病毒药物。在过去的几年里，在了解这一人群中丙型肝炎治疗方面取得了重大进展。然而，只有一小部分合并感染的患者接受了丙型肝炎病毒治疗(约15%)。此外，很少有研究探讨与HIV合并感染患者的丙型肝炎病毒治疗相关的患者决策。我们知识中的主要差距是如何最好地支持患者与他们的医疗保健提供者一起参与丙型肝炎病毒治疗决策过程。因此，这项第二阶段研究的目的是测试对艾滋病毒/丙型肝炎合并感染的成年人进行理论派生的团体干预以支持积极参与丙型肝炎治疗决策的可行性。主要目的是：(1)确定招募和保留艾滋病毒/丙型肝炎病毒混合感染成人样本的可行性，以完成一项方案，该方案涉及随机进入为期4周的丙型肝炎病毒阳性生活技能小组干预或日常护理，并完成两次数据收集访谈(在基线和12周)，(2)建立丙型肝炎病毒阳性生活技能小组干预对丙型肝炎病毒知识、决策冲突、患者与提供者沟通、健康相关生活质量、症状体验和与卫生保健提供者的接触的初步效果大小；(3)探索小组干预对丙型肝炎知识、决策冲突、患者与提供者沟通、与医疗保健提供者的接触、与健康相关的生活质量和症状体验，以及(4)描述干预和常规护理的组成部分(通过定性访谈)，这些组成部分对于帮助艾滋病毒/丙型肝炎混合感染患者参与关于丙型肝炎治疗的决策最有用。将使用混合方法方法。50名艾滋病毒/丙型肝炎病毒混合感染的参与者将被平均随机分配到小组干预或常规护理。然后，将使用定性描述方法对10-12名参与者进行定性访谈，以确定支持有关丙型肝炎治疗的有效决策的干预和日常护理中最突出的部分。我们还将比较两组所花费的时间，确定控制条件的可变性，描述开始接受丙型肝炎治疗的受试者数量，并进一步完善干预手册和干预保真度程序，为全面的多地点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进行干预措施的全面随机临床试验所需的初步证据，该干预措施旨在改善患者对艾滋病毒/丙型肝炎病毒混合感染男性和女性的治疗决策。此外，定性访谈的结果将阐明支持在这一脆弱人群中进行丙型肝炎治疗决策的最重要的问题。