Comparing Brief Alcohol Interventions for HIV-HCV Co-infected Persons

HIV-HCV 合并感染者短期酒精干预措施的比较

• 批准号: 8929096
• 负责人: Megan M Pinkston
• 金额: $ 48.33万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-20 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8929096
• 关键词: Address; Adverse effects; Aftercare; Alcohol consumption; Alcohols; American; Antiviral Agents; Behavior Therapy; Behavioral; Caring; Cause of Death; Cessation of life; Chronic Hepatitis C; Clinic; Cost Effectiveness Analysis; Counseling; Disease Progression; Genotype; Goals; Guidelines; HIV; HIV Infections; HIV-1; Health; Hepatitis C virus; Individual; Ingestion; Intervention; Interview; Link; Liver; Liver Cirrhosis; Liver Fibrosis; Liver diseases; Medical; Medical Societies; Minority; Motivation; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Population; Primary Health Care; Professional counselor; Provider; Randomized; Randomized Controlled Trials; Risk; Sampling; Secure; Target Populations; Testing; Time; United States; Visit; alcohol abstinence; alcohol measurement; authority; binge drinking; brief advice; brief alcohol intervention; brief intervention; chronic liver disease; clinical practice; co-infection; comparative effectiveness; comparative trial; compare effectiveness; cost effective; drinking; drinking behavior; effectiveness research; effectiveness trial; high risk; meetings; motivational enhancement therapy; primary care setting; primary outcome; randomized trial; response; treatment as usual; trial comparing

DESCRIPTION (provided by applicant): With over 25% of HIV-infected individuals co-infected with HCV, chronic liver disease is one the leading causes of death among persons with HIV. The majority of HIV-HCV co-infected persons continue to drink and alcohol has an adverse effect on the course of chronic HCV infection, causing more rapid progression of liver fibrosis, even at low levels of ingestion. There have been few drinking reduction trials that compare known efficacious interventions in HIV populations, and none targeting the HIV population with comorbid HCV, where the stakes of any drinking are high. Despite dramatic improvements in the treatment of HCV, only a small minority of HIV-HCV co-infected persons receives therapy due to a variety of barriers, most prominently alcohol. Medical authorities generally recommend complete abstinence from alcohol as recent evidence suggests there may be no safe level of alcohol consumption for co-infected persons. Brief behavioral interventions are the only viable approach to reduce drinking across the large and heterogeneous group of HIV-HCV drinkers in "real world" settings. Two types of brief intervention, Brief Advice (BA) and Motivational Interviewing (MI), have been shown to be efficacious in reducing drinking in non-HIV samples. Our goal is to determine whether offering counseling beyond Brief Advice, namely MI, has greater alcohol reduction effects. In the proposed randomized trial, all 300 HIV-HCV co-infected participants will receive BA delivered by their HIV PCP during a regular HIV visit and will then be randomized to either a 30-minute Motivational Interviewing Intervention with a Behavioral Counselor (MI) or to HIV clinic treatment-as-usual. After this initial meeting, drinking "check-in" (MI or BA) sessions will then be provided telephonically every three months for 18 months, with a final assessment at 24 months. Our primary outcome is drinks per week. We propose three Aims: Aim 1: To conduct a randomized controlled trial to compare the effectiveness of MI versus BA in reducing drinking among 300 HIV-HCV co-infected primary care patients; Aim 2: To compare the effectiveness of MI vs. BA on liver outcomes (FIB4, APRI, initiation of HCV treatment); Aim 3: To conduct a cost effectiveness analysis (CEA) of MI versus BA. Efficacious brief interventions focusing on reduction in alcohol use have neither targeted HCV-HIV co-infected persons nor addressed low levels of use. This proposal links alcohol use explicitly to liver disease progression and intervenes with drinking behaviors consistently over time paralleling chronic HCV infection. Both interventions being tested can be readily integrated into a variety of HIV treatment settings and are sustainable, could impact the care of co-infected persons nationwide.

描述（由申请人提供）：超过25%的HIV感染者合并HCV感染，慢性肝病是HIV感染者死亡的主要原因之一。大多数HIV-HCV合并感染者继续饮酒，酒精对慢性HCV感染的过程有不利影响，即使在低摄入水平下也会导致肝纤维化更快进展。很少有减少饮酒的试验比较已知的有效干预措施在艾滋病毒人群中，没有针对艾滋病毒感染者与HCV共病，其中任何饮酒的风险都很高。尽管HCV的治疗有了显著的改善，但由于各种障碍，最突出的是酒精，只有少数HIV-HCV合并感染者接受治疗。医学权威通常建议完全戒酒，因为最近的证据表明，对于合并感染者来说，可能没有安全的饮酒水平。在“真实的世界”环境中，对大量不同类型的HIV-HCV饮酒者进行简单的行为干预是减少饮酒的唯一可行方法。两种类型的简短干预，简短的建议（BA）和动机访谈（MI），已被证明是有效的，在减少非艾滋病毒样本的饮酒。我们的目标是确定是否提供咨询超越简短的建议，即MI，有更大的酒精减少效果。在拟议的随机试验中，所有300名HIV-HCV合并感染的参与者将在定期HIV访视期间接受由其HIV PCP提供的BA，然后将 随机分为两组，一组接受行为咨询师（MI）的30分钟动机访谈干预，另一组接受HIV诊所常规治疗。在这次初次见面后， (MI或BA）课程，然后每三个月通过电话提供一次，持续18个月，并在24个月进行最终评估。我们的主要结果是每周的饮酒量。我们提出三个目标：目标1：进行一项随机对照试验，比较MI与BA在减少300例HIV-HCV合并感染的初级保健患者饮酒方面的有效性;目的2：比较MI与BA对肝脏结局（FIB 4、APRI、启动HCV治疗）的有效性;目的3：进行MI与BA的成本效益分析（CEA）。以减少酒精使用为重点的有效的短期干预措施既没有针对HCV-艾滋病毒合并感染者，也没有解决低水平的使用问题。该提案将酒精使用明确与肝病进展联系起来，并在慢性HCV感染的同时持续干预饮酒行为。正在测试的两种干预措施都可以很容易地融入各种艾滋病毒治疗环境，并且是可持续的，可以影响全国范围内对合并感染者的护理。