IMPROVING ARV ADHERENCE: EFFECTS OF TELEPHONE FOLLOW-UP

广泛使用强效抗逆转录病毒联合治疗方案后，艾滋病毒死亡率和发病率急剧下降。然而，只有当艾滋病毒感染者坚持困难的治疗方案时，联合疗法的潜力才能实现。最大限度地坚持抗逆转录病毒疗法并充分发挥其潜力，需要采取多方面的举措，解决复杂的行为和生物医学问题。这项前瞻性、随机对照试验将测试从自我调节模型中提取的干预措施的有效性。自我调节理论强调患者对其疾病和治疗的认知的重要性，并提供了一个有用的框架，以扩大以患者为中心的理解参与抗逆转录病毒药物依从性行为的动态因素。本研究的主要目的是：(1)确定基于理论的ARV干预是否能增加依从性；(2)确定干预是否能改善健康结果（病毒学、免疫学、临床事件、生活质量）。次要目标是：(1)确定干预是否改变了艾滋病毒疾病的代表性；(2)确定HIV疾病代表是否能预测抗逆转录病毒药物的依从性；(3)确定干预对抗逆转录病毒药物依从性和健康结果的影响是否由艾滋病毒疾病代表介导；(3)提供干预成本的分析。干预措施将在一个不同的社区样本中进行测试，样本包括200名通过俄亥俄州卫生部艾滋病毒/艾滋病药物援助计划（ADAP）接受药物治疗的个人。这一干预措施的重点是了解患者的艾滋病毒疾病代表情况，并：(1)提供核心信息、技能和情感支持，以促进符合抗逆转录病毒药物依从性的代表情况；(2)解决艾滋病毒患者疾病代表中与抗逆转录病毒药物依从性不一致的现有观念。干预措施将由具有艾滋病毒护理专业知识的训练有素的注册护士通过预定的电话会议（第1、2、3、4、6、8、10、12、16、20、24、28、32、36周）和咨询（每天16小时的寻呼机访问）提供。将在基线和1、3、6、9和12个月采取措施。项目数据收集时间为3年。研究结果将对理论发展、艾滋病临床实践和政策产生影响。

Dramatic reductions in HIV mortality and morbidity have followed the widespread use of potent combination antiretroviral (ARV) medication regimens. Yet, the potential of the combination therapies can be realized only if people living with HIV adhere to the difficult treatment regimens. Maximizing adherence and achieving the full potential of the antiretroviral therapies demand multidimensional initiatives that address complex behavioral and biomedical issues. This prospective, randomized controlled trial will test the effectiveness of an intervention that is drawn from a self-regulation model. Self-regulation theory emphasizes the importance of patients' perceptions about their illness and treatment and provides a useful framework for broadening a patient-centered understanding of the dynamic factors involved in ARV medication adherence behavior. The primary aims of this study are: (1) To determine if the theory- based ARV intervention increases adherence, and; (2) To determine if the intervention improves health outcomes (virologic, immunologic, clinical events, QOL). Secondary aims are: (1) To determine if HIV illness representation is changed as a result of the intervention; (2) To determine if HIV illness representation predicts ARV adherence; (3) To determine if the effect of the intervention on ARV adherence and health outcomes is mediated by HIV illness representation, and; (3) To provide an analysis of the cost of the intervention. The intervention will be tested in a diverse community-based sample of 200 individuals who are receiving medications through the Ohio Department of Health HIV/AIDS Drug Assistance Program (ADAP). The focus of this intervention is on understanding the patient's HIV illness representation and: (1) providing a core of information, skills and affective support to promote a representation consistent with ARV adherence, and; (2) addressing existing perceptions within the HIV patient's illness representation that are inconsistent with ARV adherence. The intervention will be delivered by trained registered nurses with expertise in HIV care via scheduled telephone sessions (weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36) and consultation (16 hr/day pager access). Measures will be taken at baseline and 1, 3, 6, 9 and 12 months. The duration of project data collection is 3 years. Findings will have implications for theory development, HIV clinical practice and policy.