PROMOTING ANTIVIRAL MEDICATION ADHERENCE IN HIV CLINICS

这是该项目的修订提案，推广抗病毒药物 在艾滋病毒诊所的坚持，这将测试一种 促进用药依从性和改善临床结局的干预措施 对于即将开始联合抗逆转录病毒治疗的患者。这个 研究将在三家大型成人艾滋病毒门诊进行， 以少数民族为主的男性和女性接受医疗补助，两岁 纽约市主要教学医院(哥伦比亚-长老会和纽约 约克医院/康奈尔大学医学中心)。“综合疗法，” 至少有两种抗逆转录病毒药物，通常包括一种蛋白酶 抑制剂，已经成为护理的标准，并被证明是有效的 在减少许多患者的艾滋病毒病毒载量方面。然而，这些令人兴奋的事情 治疗的进步带来了与以下方面的重大挑战 药物依从性。因为患者可能会产生抵抗力并产生交叉反应 错过一周后(对所有其他蛋白水解酶抑制剂)产生耐药性 用药不规律，或剂量不全，有严重的 对个人的后果和潜在的公共健康后果 同样，因为抗药性病毒株可以传播给其他人。 这些诊所中所有同意医生建议的患者 建议开始(或切换到)联合治疗，包括 一种蛋白水解酶抑制剂将是合格的。参与者将被随机分配到 要么是研究的对照(“日常护理”)的干预，要么是 所有人都将在基线以及第4、12和26周进行评估。这个 认知-行为干预是结构化的和理论驱动的。 由护士教育人员讲授，重点是最大限度地提高准确性 对组合的医学和实践方面的理解 治疗和解决坚持的实际障碍，最大化信仰 在个人控制或自我效能上，最大化感知和实践 社会支持。在第一阶段将有四个急性期会议 开始联合治疗的一个月(“重拳出击，及早出击”)和四个月 每隔一个月连续举行一次维护会议。主要成果 措施包括行为依从性和临床效果方面的 艾滋病毒核糖核酸病毒载量下降。 这项研究的主要目标是测试我们的 干预；次要目标是检查 依从性和临床结果，并确定精神，心理社会， 依从性和临床结果的医学和情景预测因子。

This is a revised proposal for the project, Promoting Antiviral Medication Adherence in HIV Clinics, which will test the effectiveness of an intervention to promote medication adherence and improve clinical outcome for patients about to initiate combination anti-retroviral therapy. The study will be conducted in three large adult HIV outpatient clinics, treating predominantly ethnic minority men and women n Medicaid, at two major teaching hospitals in New York City (Columbia-Presbyterian and New York Hospital/Cornell University Medical Centers). "Combination therapy," with at least two anti-retroviral drugs, and usually including a protease inhibitor, has become the standard of care and is demonstrably effective in reducing HIV viral load for many patients. However, these exciting therapeutic advances bring with them major challenges with respect to medication adherence. Since patients can develop resistance and cross- resistance (to all other protease inhibitors) after only a week of missed medication, irregular use, or incomplete doses, there are serious consequences for the individual and potential public health consequences as well, since resistant viral strains can be transmitted to others. All patients in these clinics who have agreed with their doctor's recommendation to start (or switch to) combination therapy that includes a protease inhibitor will be eligible. Participants will be randomized to either the intervention of control ("usual care") arm of the study, and all will have assessments at baseline and Weeks 4, 12, and 26. The cognitive-behavioral intervention is structured and theory-driven. Delivered by a nurse educator, it focuses on maximizing accurate understanding of the medical and practical aspects of combination treatment an resolving practical barriers to adherence, maximizing belief in person control or self-efficacy, and maximizing perceived and practical social support. There will be four acute phase sessions during the first month of initiating combination therapy ("hit hard, hit early") and four maintenance sessions at successive monthly intervals. Major outcome measures include behavioral adherence and clinical effect in terms of decline in HIV RNA viral load. The primary goal of the study is to test the effectiveness of our intervention; secondary goals are to examine the relationship between adherence and clinical outcome and to identify psychiatric, psychosocial, medical, and situational predictors of adherence and clinical outcome.