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: 8523703
• 负责人: REBECCA K PAPAS
• 金额: $ 50.59万
• 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/8523703
• 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）：危险和酗酒与危险性行为增加、抗逆转录病毒治疗（ARVs）依从性差以及抗逆转录病毒药物对艾滋病毒感染者的毒性有关。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，或至少每月每次饮用e6杯）对艾滋病毒传播和疾病进展有重大影响。在肯尼亚西部，艾滋病毒门诊患者（53%）和普通医学门诊患者（68%）危险饮酒的流行率特别高，部分原因是传统烈性啤酒的广泛供应。越来越多的证据表明，酗酒是成功降低性风险方法的障碍。该小组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1期试验，以减少74名感染艾滋病毒的肯尼亚人的酒精使用（R21AA017884）。结果证明了该方法的可行性和可接受性，并在后处理时估计了较大的治疗效果。我们现在建议对CBT酒精干预进行大规模的2期疗效试验。我们的目标是在一项包括主动对照和较长随访期的大型ii期试验中，评估“减少酒精首先在肯尼亚干预”（RAFIKI）在减少酒精使用方面的功效。Rafiki在肯尼亚的官方语言斯瓦希里语中是朋友的意思。这项试验将由肯尼亚健康行为研究小组（KHBS）进行，这是一个由肯尼亚和美国的行为科学家、医生、康复中的药物使用者和艾滋病毒感染者组成的经验丰富的小组。KHBS扩展了提供医疗保健学术模式（AMPATH）与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个诊所治疗超过75000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的培训、治疗和保真度评级手册，成功的辅助专业干预交付模式，临床评估工具，以及经验丰富的当地培训师和主管团队。我们的具体目标是：1)在一项随机临床试验中，对336名报告危险饮酒或酗酒的肯尼亚艾滋病毒感染门诊患者进行了同性群体CBT干预，并与时间匹配的健康生活方式教育干预组进行了比较；2)进行分析，检验干预效果的机制；3)探索性分析干预条件与性危险行为的关系。我们的目标与NIAAA在弱势人群中减少酒精使用和艾滋病毒风险的使命是一致的，这将为辅助专业领导的群体CBT的有效性提供强有力的测试，并可能为撒哈拉以南非洲的其他环境提供可持续和可运输的干预措施。