PROMOTING ANTIVIRAL MEDICATION ADHERENCE IN HIV CLINICS

这是一个修订后的建议，为项目，促进抗病毒药物 艾滋病诊所的依从性，这将测试一个 促进药物依从性和改善临床结局的干预措施 为即将开始联合抗逆转录病毒治疗的患者提供。的 研究将在三个大型成人艾滋病门诊诊所进行， 治疗主要是少数民族男性和女性的医疗补助，在两个 纽约市的主要教学医院（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，通常包括蛋白酶 抑制剂，已成为护理标准，并证明有效 在降低艾滋病毒载量方面。然而，这些令人兴奋的 治疗进展带来了重大挑战， 药物依从性。因为病人会产生耐药性， 耐药性（所有其他蛋白酶抑制剂）后，只有一个星期的错过 服药，不规则使用，或不完整的剂量，有严重的 对个人的后果和潜在的公共卫生后果 同时，由于耐药病毒株可以传播给其他人。 这些诊所里所有同意医生建议的病人 建议开始（或转为）联合治疗，包括 蛋白酶抑制剂将是合格的。受试者将被随机分配至 研究的干预或对照（“常规护理”）组，以及 所有人都将在基线和第4、12和26周进行评估。的 认知行为干预是结构化和理论驱动的。 由护士教育者提供，它侧重于最大限度地准确 了解医学与实践相结合的方面 治疗是解决依从性的实际障碍，最大限度地提高信念 在个人控制或自我效能，并最大限度地提高感知和实际 社会抚养费第一阶段将有四次急性期会议， 开始联合治疗（“用力打，尽早打”）的一个月， 每月定期进行维护。主要成果 措施包括行为依从性和临床效果， HIV RNA病毒载量下降。 这项研究的主要目的是测试我们的 干预;次要目标是检查 依从性和临床结果，并确定精神病学，社会心理学， 医学和依从性和临床结果的情境预测因素。

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.