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: 8839916
• 负责人: Megan M Pinkston
• 金额: $ 50.84万
• 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/8839916
• 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; Hepatitis C virus; Individual; Infection; 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; 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; public health relevance; 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(申请人提供)：超过25%的艾滋病毒感染者同时感染丙型肝炎病毒，慢性肝病是艾滋病毒携带者死亡的主要原因之一。大多数艾滋病毒-丙型肝炎病毒混合感染者继续饮酒，酒精对慢性丙型肝炎病毒感染过程有不利影响，即使在低摄入量的情况下，也会导致肝纤维化进展更快。很少有减少饮酒的试验将艾滋病毒人群中已知的有效干预措施进行比较，也没有一项针对艾滋病毒人群与丙型肝炎病毒共病的试验，在丙型肝炎病毒感染中，任何饮酒的风险都很高。尽管丙型肝炎病毒的治疗有了很大的改进，但由于各种障碍，最突出的是酒精，只有一小部分艾滋病毒-丙型肝炎病毒混合感染者接受治疗。医疗当局通常建议完全戒酒，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。简单的行为干预是在“现实世界”环境中减少大量不同种类的艾滋病毒-丙型肝炎病毒饮酒者饮酒的唯一可行方法。两种类型的简短干预--简短建议(BA)和动机访谈(MI)--已被证明在减少非HIV样本饮酒方面有效。我们的目标是确定在简短建议之外提供咨询，即MI，是否有更大的戒酒效果。在拟议的随机试验中，所有300名艾滋病毒-丙型肝炎病毒共同感染的参与者将在定期艾滋病毒访问期间获得由他们的艾滋病毒初级保健医生提供的BA，然后将被 随机分为行为咨询师(MI)进行30分钟的激励性访谈干预，或照常进行HIV临床治疗。在第一次见面后，喝着“签到” 然后，每三个月以电话形式提供(MI或BA)课程，为期18个月，最后评估为24个月。我们的主要结果是每周喝几杯。我们提出了三个目标：目标1：进行随机对照试验，比较MI和BA在300名HIV-HCV合并感染的初级保健患者中减少饮酒的有效性；目标2：比较MI和BA对肝脏结局(FIB4、APRI、丙型肝炎病毒治疗开始)的有效性；目标3：进行MI和BA的成本效果分析(CEA)。以减少饮酒为重点的有效的短暂干预既没有针对丙型肝炎病毒-艾滋病毒共同感染者，也没有解决低水平的饮酒问题。这项建议明确地将饮酒与肝病进展联系在一起，并随着时间的推移持续干预饮酒行为，同时伴随着慢性丙型肝炎病毒感染。正在测试的这两种干预措施可以很容易地整合到各种艾滋病毒治疗环境中，并且是可持续的，可能会影响全国范围内对共同感染者的护理。