A Stage 2 cognitive-behavioral trial: Reduce Alcohol First in Kenya Intervention

第二阶段认知行为试验：肯尼亚干预中首先减少饮酒

• 批准号: 8719879
• 负责人: REBECCA K PAPAS
• 金额: $ 52.12万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8719879
• 关键词: Adherence; Africa South of the Sahara; Aftercare; Agreement; Alcohol consumption; Alcohols; Behavioral; Biological Markers; Clinic; Clinical; Clinical Assessment Tool; Cognitive; Cognitive Therapy; Consumption; Coping Skills; Disease Progression; Education; Educational Intervention; Frequencies; Friends; Goals; HIV; HIV Infections; HIV risk; Health Services Accessibility; Health behavior; Health education; Heavy Drinking; Individual; Intervention; Kenya; Language; Life Style; Manuals; Maps; Matched Group; Measures; Mediating; Medicine; Mission; Modeling; Outpatients; Patient Self-Report; Patients; Persons; Phase; Physicians; Prevalence; Professional counselor; Randomized Clinical Trials; Recovery; Reporting; Resources; Risk Reduction; Sampling; Scientist; Services; Staging; Test Result; Testing; Time; Toxic effect; Traditional Birth Attendants; Training; Universities; Unsafe Sex; Vulnerable Populations; active control; active method; alcohol intervention; alcohol use disorder; antiretroviral therapy; base; binge drinking; cost effective; drinking; efficacy testing; efficacy trial; experience; follow-up; hazardous drinking; high risk sexual behavior; intervention effect; medical schools; peer; reduced alcohol use; sex; sex risk; transmission process; treatment effect

DESCRIPTION (provided by applicant): Hazardous and binge drinking have been associated with increased risky sexual behavior, poor adherence to antiretroviral therapy (ARVs) and toxicity from ARVs among those with HIV infection. As such, hazardous and binge drinking (score of e3 on the Alcohol Use Disorders Test - Consumption (AUDIT-C), or e6 drinks per occasion at least monthly) have a major impact on HIV transmission and disease progression. Prevalence rates of hazardous drinking are particularly high among HIV (53%) and general medicine (68%) outpatients in western Kenya, in part due to the wide availability of potent traditional brew. Growing evidence suggests that heavy drinking is an obstacle to successful sexual risk reduction approaches. This team recently completed a Stage 1 trial of a group cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among 74 HIV-infected Kenyans (R21AA017884). Results demonstrated feasibility, acceptability and estimated a large treatment effect at post-treatment. We now propose a large Stage 2 efficacy trial of the CBT alcohol intervention. Our goal is to evaluate the efficacy of the Reduce Alcohol First in Kenya Intervention (RAFIKI) in its ability to reduce alcohol use within a larger Stage 2 trial that includes an active control and a longer follow-up period. Rafiki means friend in Kiswahili, the national language of Kenya. The trial will be conducted by the Kenya Health Behavior Study (KHBS) team, an experienced group of Kenyan and U.S. behavioral scientists, physicians, substance users in recovery and persons infected with HIV. KHBS expands on well-established ties between the Academic Model for Providing Access to Healthcare (AMPATH) and the Brown University Medical School, which has been an active AMPATH partner since 1997. AMPATH currently treats more than 75,000 HIV-infected patients in 25 clinics in western Kenya. As part of these efforts, we have ready locally adapted training, treatment and fidelity rating manuals, a successful paraprofessional intervention delivery model, clinical assessment tools, and an experienced local team of trainers and supervisors. Our specific aims are to: 1) To examine the efficacy of a same-sex group CBT intervention in a randomized clinical trial of 336 HIV-infected Kenyan outpatients who report hazardous or binge drinking, when compared to a time-matched group Healthy Lifestyles education intervention; 2) To conduct analyses to examine the mechanisms of intervention effects; and 3) To conduct exploratory analyses to examine the relationship between intervention condition and sexual risk behaviors. Completion of our objectives, which are consistent with NIAAA's mission to reduce both alcohol use and HIV risk in vulnerable populations, will provide a robust test of efficacy of the paraprofessionally led group CBT and potentially provide a sustainable and transportable intervention for other settings in sub-Saharan Africa.

描述（由申请人提供）：危险和酗酒与艾滋病毒感染者的危险性行为增加、抗逆转录病毒治疗（ARVs）依从性差和ARVs毒性有关。因此，危险饮酒和酗酒（酒精使用障碍测试-消费（AUDIT-C）得分为e3，或至少每月每次饮酒e6）对艾滋病毒传播和疾病进展有重大影响。在肯尼亚西部，艾滋病毒（53%）和普通内科（68%）门诊病人中危险饮酒的流行率特别高，部分原因是烈性传统啤酒的广泛供应。越来越多的证据表明，大量饮酒是成功降低性风险方法的障碍。该团队最近完成了一项由辅助专业人员提供的群体认知行为疗法（CBT）干预的第一阶段试验，以减少74名艾滋病毒感染者的饮酒（R21 AA 017884）。结果证明了可行性、可接受性，并估计在治疗后具有较大的治疗效果。我们现在提出了一个大的CBT酒精干预的第二阶段疗效试验。我们的目标是评估肯尼亚减少酒精第一干预措施（RAFIKI）在更大规模的第2阶段试验中减少酒精使用的能力的有效性，该试验包括积极控制和更长的随访期。Rafiki在肯尼亚的国语斯瓦希里语中是朋友的意思。该试验将由肯尼亚健康行为研究（KHBS）团队进行，该团队由肯尼亚和美国的行为科学家，医生，康复中的物质使用者和艾滋病毒感染者组成。KHBS扩展了提供医疗保健的学术模式（AMPATH）和布朗大学医学院之间的良好关系，布朗大学医学院自1997年以来一直是AMPATH的积极合作伙伴。AMPATH目前在肯尼亚西部的25个诊所治疗75 000多名艾滋病毒感染者。作为这些努力的一部分，我们准备了适合当地情况的培训、治疗和忠诚度评级手册，一个成功的准专业干预提供模式，临床评估工具，以及一个经验丰富的当地培训师和监督员团队。我们的具体目标是：1）在一项随机临床试验中，与时间匹配的健康生活方式教育干预组相比，对336名报告危险或酗酒的肯尼亚艾滋病毒感染者进行同性群体CBT干预的有效性进行检查; 2）进行分析，以检查干预效果的机制;（3）探索性分析干预条件与危险性行为的关系。我们的目标，这是符合NIAAA的使命，以减少酒精的使用和艾滋病毒的风险在弱势群体，将提供一个强大的测试效果的准专业领导的小组CBT和潜在的提供一个可持续的和可移动的干预撒哈拉以南非洲的其他设置。