Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-led Alcohol Behavior Intervention

描述（由申请人提供）：酒精使用和滥用与危险性行为增加、抗逆转录病毒治疗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，酒精使用和滥用对艾滋病毒传播和疾病进展具有重大影响。由于酒精滥用在肯尼亚很普遍，据估计，普通医学诊所的危险饮酒比例高达68%，艾滋病毒诊所的危险饮酒比例高达53%，因此我们建议开展第一阶段试点项目，以开发和评估针对有资格接受抗逆转录病毒治疗的艾滋病毒感染肯尼亚人饮酒的同伴领导的群体认知行为治疗（CBT）。尽管CBT非常适合肯尼亚的环境，因为它相对结构化，并且与肯尼亚饮酒行为的概念模型一致，但由于肯尼亚精神卫生专业人员的供应极其有限，它需要适应同伴交付。这项为期24个月的能力建设R21研究的目标是评估CBT新应用的有效性，这是肯尼亚埃尔多雷特的一个6期同伴领导小组，与常规护理支持小组相比，减少艾滋病毒感染成人的危险饮酒和酗酒。这项工作将通过肯尼亚-美国合作项目进行。艾滋病毒与酒精研究和预防伙伴关系（KHARPP）——一个由肯尼亚和美国的医生、行为科学家、康复药物使用者和艾滋病毒感染者组成的经验丰富的团队。KHARPP扩展了预防和治疗艾滋病毒/艾滋病学术模型（AMPATH）和退伍军人老龄化队列研究（VACS）之间的良好关系，VACS是一项关于艾滋病毒和酒精的纵向临床研究。AMPATH在肯尼亚西部的15个诊所治疗了2.5万多名患者。作为这些努力的一部分，我们已经完成了对斯瓦希里语的翻译和CBT协议的改编，筛查和结果工具的翻译，以及当地酿造饮料的种类和份量的量化。我们的具体目标是：1)培训2名肯尼亚心理学家，使用标准化的依从性/质量评级量表对同伴主导的CBT模式进行持续的质量/保真度监测；2)培训4名肯尼亚同伴辅导员进行标准化CBT干预，以减少酒精使用；3)通过一项为期6周的小型试验评估同伴主导的群体CBT干预的可行性，该试验将56名感染艾滋病毒的肯尼亚人随机分配到同性CBT或常规护理艾滋病毒支持小组。我们的目标与NIAAA在弱势群体中减少酒精使用和艾滋病毒风险的使命是一致的，完成这些目标将产生以下产品：(1)用英语和斯瓦希里语编写的CBT干预的完整手册，(2)临床医生培训材料和过程评级表格，(3)试点研究的效应大小初步指标，以及适用于该环境和人群的酒精相关评估工具。如果CBT干预在第一阶段的研究中被证明是有希望的，那么这些材料应该足以在肯尼亚的其他HIV诊所中对这一人群进行完整的“第二阶段”随机试验。这项研究将确定认知行为干预是否在美国证明了减少酒精使用的有力证据，在肯尼亚与常规护理支持小组相比是否有效。它将由艾滋病毒感染者提供，这些人可能没有受过什么正规教育，但接受过标准化干预方法方面的培训，并敏锐地了解感染艾滋病毒和有酗酒问题的同龄人的需要。这种做法符合在资源贫乏环境中成功的具有成本效益的服务提供模式，在这种模式中，非专业人员（如临床官员、传统助产士和同伴咨询师）接受了培训。

DESCRIPTION (provided by applicant): Alcohol use and abuse 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, alcohol use and abuse have a major impact on HIV transmission and disease progression. Because alcohol abuse is widespread in Kenya, with estimates of hazardous drinking as high as 68% in general medicine clinics and 53% in HIV clinics, we propose a Stage 1 pilot project to develop and evaluate a peer-led group cognitive behavioral treatment (CBT) targeting alcohol use among HIV infected Kenyans who are eligible for ARV therapy. Although CBT is well-suited to the Kenyan setting because it is comparatively structured and consistent with the Kenyan conceptual model of drinking behavior, it requires adaptation for peer delivery due to the extremely limited supply of Kenyan mental health professionals. The goal of this 24-month capacity- building R21 study is to evaluate the efficacy of a novel application of CBT, a 6-session peer-led group in Eldoret, Kenya, when compared against a usual care support group, to reduce hazardous and binge drinking among adult persons infected with HIV. This work will be conducted via the Kenya-U.S. HIV and Alcohol Research and Prevention Partnership (KHARPP)-an experienced team of Kenyan and U.S. physicians, behavioral scientists, recovered substance users and persons infected with HIV. KHARPP expands on well- established ties between the Academic Model for Prevention and Treatment of HIV/AIDS (AMPATH) and the Veterans Aging Cohort Study (VACS), a longitudinal clinical study of HIV and alcohol. AMPATH treats more than 25,000 patients in 15 clinics in western Kenya. As a part of these efforts, we have already completed translation to Kiswahili and adaptation of the CBT protocol, translation of the screening and outcome instruments, and the quantification of types and serving sizes of locally brewed drinks. Our specific aims are to: 1) train 2 Kenyan psychologists to provide ongoing quality/fidelity monitoring of the peer-led CBT model using standardized adherence/quality rating scales; 2) train 4 Kenyan peer facilitators in the standardized CBT intervention to reduce alcohol use; and 3) evaluate the feasibility of the peer-led group CBT intervention via a small, 6-week trial in which 56 HIV infected Kenyans are randomized to same-sex CBT or usual care HIV support groups. Completion of our objectives, which are consistent with NIAAA's mission to reduce both alcohol use and HIV risk in vulnerable populations, will result in the following products: (1) a complete manual for the CBT intervention in both English and Kiswahili, (2) clinician training materials and process rating forms, (3) preliminary indicators of effect size from the pilot study, and well as adapted alcohol-related assessment instruments for this setting and population. If the CBT intervention is demonstrated to have promise in this Stage 1 study, these materials should be sufficient to develop a full "Stage 2" randomized trial with this population to be implemented at additional HIV clinics in Kenya. This study will determine whether a cognitive behavioral intervention that demonstrates strong evidence in the U.S. of reducing alcohol use is effective in Kenya, when compared against a usual care support group. It will be delivered by individuals who are infected with HIV and may have little formal education but who are trained in standardized intervention methods and keenly aware of the needs of their peers with HIV infection and alcohol problems. This approach is consistent with successful cost-effective models of service delivery in resource-poor settings in which lay individuals (e.g., clinical officers, traditional birth attendants and peer counselors) are trained.