PROMOTING ANTIVIRAL MEDICATION ADHERENCE IN HIV CLINICS

促进艾滋病毒诊所中抗病毒药物的依从性

• 批准号: 6358087
• 负责人: ROBERT H REMIEN
• 金额: $ 49.87万
• 依托单位: NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-23 至 2001-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6358087
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; antiAIDS agent; antiviral agents; attitude; belief; clinical research; cognitive behavior therapy; combination therapy; counseling; health care service utilization; human subject; outcomes research; social support network; statistics /biometry; therapy compliance; virus load

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.

这是该项目的修订建议，促进抗病毒药物 艾滋病毒诊所的依从性，该诊所将测试 干预以促进药物依从性并改善临床结果 对于即将启动抗逆转录病毒疗法的患者。这 研究将在三个大型成人HIV门诊诊所进行， 在两个医疗补助下，主要是少数民族男性和女人 纽约市的主要教学医院（哥伦比亚长老会和新医院 约克医院/康奈尔大学医学中心）。 “联合疗法”，” 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，并且明显有效 在减少许多患者的HIV病毒负荷方面。但是，这些令人兴奋 治疗进步带来了有关的主要挑战 药物依从性。由于患者可以发展耐药性和交叉 仅一周后，阻力（对所有其他蛋白酶抑制剂） 药物治疗，不规则使用或不完整剂量，有严重的 对个人和潜在公共卫生后果的后果 同样，由于可以将抗性病毒菌株传播给其他人。 这些诊所中的所有患者都同意医生的 建议开始（或切换到）组合疗法，包括 蛋白酶抑制剂将符合条件。参与者将被随机 研究的干预（“常规护理”）部门，以及 所有人都将在基线和第4、12和26周进行评估。 认知行为干预是结构化的，理论驱动的。 由护士教育者交付，重点是最大化准确的 理解组合的医学和实际方面 治疗依从性的实用障碍，最大化信念 亲自控制或自我效能感，并最大化感知和实用 社会支持。第一次会有四个急性期会话 启动组合疗法的月份（“命中率高，早击”）和四个 连续每月间隔维护会议。主要结果 措施包括行为依从性和临床效应 HIV RNA病毒负荷下降。 该研究的主要目标是测试我们的有效性 干涉;次要目标是检查 依从性和临床结果，并识别精神病，社会心理， 医学和依从性和临床结果的情况预测因素。