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: 8332269
• 负责人: REBECCA K PAPAS
• 金额: $ 51.94万
• 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/8332269
• 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; 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; 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)：在HIV感染者中，危险和酗酒与危险的性行为增加、抗逆转录病毒治疗(ARV)的依从性差以及ARV的毒性有关。因此，危险饮酒和酗酒(酒精使用障碍测试-消费测试(AUDIT-C)的E3分，或至少每月每次饮酒e6分)对艾滋病毒传播和疾病进展有重大影响。在肯尼亚西部的艾滋病毒(53%)和普通内科(68%)门诊患者中，危险饮酒的流行率特别高，部分原因是强大的传统啤酒的广泛可获得性。越来越多的证据表明，大量饮酒是成功减少性风险方法的障碍。该团队最近完成了由准专业人员提供的团体认知行为疗法(CBT)干预的第一阶段试验，以减少74名感染艾滋病毒的肯尼亚人(R21AA017884)的酒精使用。结果证明了治疗的可行性和可接受性，并在治疗后评估了较大的治疗效果。我们现在建议进行一项CBT酒精干预的大型第2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)在包括积极对照和更长随访期的更大的第2阶段试验中减少酒精使用的能力的有效性。拉菲基在肯尼亚的国语斯瓦希里语中的意思是朋友。这项试验将由肯尼亚健康行为研究(KHBS)团队进行，该团队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扩展了提供医疗服务学术模式(AMPATH)与布朗大学医学院之间的良好关系，自1997年以来，布朗大学医学院一直是AMPATH的积极合作伙伴。AMPATH目前在肯尼亚西部的25家诊所治疗超过7.5万名艾滋病毒感染患者。作为这些努力的一部分，我们准备了适合当地情况的培训、治疗和保真度评估手册，成功的半专业干预提供模式，临床评估工具，以及经验丰富的当地培训员和监督员团队。我们的具体目标是：1)在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的随机临床试验中，检查同性群体CBT干预的有效性，并与时间匹配的健康生活方式教育干预组进行比较；2)进行分析，以检查干预效果的机制；以及3)进行探索性分析，以检查干预条件和性危险行为之间的关系。我们目标的完成与NIAAA在弱势人群中减少酒精使用和艾滋病毒风险的使命相一致，将对半专业领导的CBT小组的有效性进行强有力的测试，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。