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: 8210190
• 负责人: REBECCA K PAPAS
• 金额: $ 55.16万
• 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/8210190
• 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. PUBLIC HEALTH RELEVANCE: This study will determine whether a group cognitive-behavioral therapy intervention that demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in western Kenya is effective when compared against a group health education intervention in a large sample over a longer period of time. It will be delivered by paraprofessionals, individuals with limited formal education and little or no relevant professional experience. This approach is consistent with successful cost-effective models of service delivery in resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional birth attendants and peer counselors) are trained.

描述（由申请人提供）：在 HIV 感染者中，危险饮酒和酗酒与危险性行为增加、抗逆转录病毒治疗 (ARV) 依从性差以及 ARV 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 HIV 传播和疾病进展具有重大影响。在肯尼亚西部的艾滋病毒（53%）和普通内科（68%）门诊患者中，危险饮酒的患病率特别高，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进行的团体认知行为治疗 (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量 (R21AA017884)。结果证明了可行性、可接受性，并在治疗后估计了很大的治疗效果。我们现在提议对 CBT 酒精干预进行大型第二阶段疗效试验。我们的目标是评估肯尼亚首先减少饮酒干预措施 (RAFIKI) 在更大规模的第 2 阶段试验（包括主动控制和更长的随访期）中减少饮酒的能力。 Rafiki 在肯尼亚的国语斯瓦希里语中意为朋友。该试验将由肯尼亚健康行为研究（KHBS）团队进行，该团队由经验丰富的肯尼亚和美国行为科学家、医生、康复中的药物使用者和艾滋病毒感染者组成。 KHBS 扩大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联系，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 家诊所治疗了超过 75,000 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、成功的专业辅助干预实施模式、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) 与时间匹配的团体健康生活方式教育干预相比，在一项随机临床试验中检验同性团体 CBT 干预的效果，该试验涉及 336 名报告危险饮酒或酗酒的艾滋病毒感染肯尼亚门诊患者； 2）分析干预效果的机制； 3）进行探索性分析，检验干预条件与性危险行为之间的关系。我们的目标与 NIAAA 减少弱势群体饮酒和艾滋病毒风险的使命相一致，我们的目标的完成将为专业人员领导的小组 CBT 的功效提供强有力的测试，并有可能为撒哈拉以南非洲的其他环境提供可持续和可转移的干预措施。 公共卫生相关性：本研究将确定，与长期大样本的团体健康教育干预相比，团体认知行为治疗干预是否有效，该干预初步证明肯尼亚西部艾滋病毒感染者门诊患者减少饮酒的证据是否有效。它将由辅助专业人员、受过有限正规教育且很少或没有相关专业经验的个人来提供。这种方法与在资源有限的环境中成功的、具有成本效益的服务提供模式是一致的，在这种模式中，专业人员（例如临床官员、传统助产士和同伴咨询师）接受了培训。