IMPROVING ARV ADHERENCE: EFFECTS OF TELEPHONE FOLLOW-UP

在广泛使用有效的联合抗逆转录病毒(ARV)药物方案后，艾滋病毒死亡率和发病率大幅下降。然而，只有艾滋病毒携带者坚持困难的治疗方案，联合疗法的潜力才能实现。最大限度地坚持和实现抗逆转录病毒疗法的全部潜力需要多方面的倡议，以解决复杂的行为和生物医学问题。这项前瞻性的随机对照试验将测试来自自我调节模型的干预的有效性。自我调节理论强调了患者对疾病和治疗的看法的重要性，并为拓宽以患者为中心的对ARV药物依从性行为所涉及的动态因素的理解提供了一个有用的框架。这项研究的主要目的是：(1)确定基于理论的ARV干预是否增加了依从性，以及(2)确定干预是否改善了健康结局(病毒学、免疫学、临床事件、生活质量)。次要目标是：(1)确定HIV疾病表征是否因干预而改变；(2)确定HIV疾病表征是否预测ARV依从性；(3)确定干预对ARV依从性和健康结果的影响是否通过HIV疾病表征来调节；以及(3)提供干预成本分析。这项干预措施将在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200名不同社区样本中进行测试。这项干预的重点是了解患者的HIV疾病陈述，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治疗标准的陈述；以及(2)解决HIV患者疾病陈述中与坚持抗逆转录病毒药物不一致的现有看法。干预将由训练有素、具有艾滋病毒护理专业知识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)和会诊(16小时/天寻呼机接入)进行。将在基线和1、3、6、9和12个月采取措施。项目资料收集期限为3年。这些发现将对理论发展、艾滋病毒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.