Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

描述(申请人提供)：尽管艾滋病毒疾病的抗逆转录病毒疗法(ART)广泛可用和有效，但仍有相当数量的晚期疾病患者没有接受治疗，由于无法获得抗逆转录病毒疗法而死亡的艾滋病毒+患者的数量令人震惊。这项拟议研究的目的是开发和测试一种干预措施，为根据目前的治疗指南应该接受但目前没有接受抗逆转录病毒治疗的HIV+男性和女性做好准备。这一研究的首要目标是防止因无法获得抗逆转录病毒疗法而导致的不必要的死亡，而拟议干预的直接目标是解决抗逆转录病毒药物吸收/启动的障碍。拟议的工作以信息、动机、行为技能(MB)模型为基础，干预措施的设计将积极增强信息(例如在哪里以及如何获得护理)、动机(例如治疗的好处)和行为技能(例如解决问题、与提供者沟通)，以增加对ART的接受和遵守。我们的团队就治疗期望值和准备情况这一主题进行了广泛的形成性研究，包括与患者、提供者的访谈，以及初步干预的试点。我们现在建议通过开发基于上面概述的内容的混合模式干预来扩展这项工作，该混合模式干预将在随机对照试验中与滞后干预条件进行比较。感兴趣的人群是那些艾滋病毒携带者和CD4细胞计数低但不接受抗逆转录病毒治疗的人，他们更有可能是少数族裔，精神疾病、药物使用和其他成功管理艾滋病毒的障碍较高。然而，他们最有可能死于艾滋病相关疾病，如果他们不进行有效的治疗，就有将艾滋病毒传播给他人的风险。我们的团队对这类人群有经验，我们计划使用在这种情况下被证明有效的招聘、保留和评估方案。我们将招募300名未接受抗逆转录病毒治疗的HIV感染者，他们将被随机分为立即干预和滞后干预两组。干预将包括一对一会议和由跨学科专家和同行领导的单一小组会议。建议召开助推器会议，以加强干预。主要结果将是ART的启动(吸收)，次要结果将是ART依从性、CD4、病毒载量、健康状况和发病率。随访评估将在3、6和12个月进行，并在0、6和12个月进行CD4和病毒载量的评估。

DESCRIPTION (provided by applicant): Despite the widespread availability and effectiveness of antiretroviral therapy (ART) for HIV disease, there is a substantial population with advanced disease who are not on therapy, and an alarming number of HIV+ people die due to failure to access ART. The purpose of the proposed research is to develop and test an intervention to prepare HIV+ men and women who, based on current treatment guidelines, should be but are not currently taking ART. The overarching goal of this line of research is to prevent unnecessary death due to failure to access ART, and the immediate goal of the proposed intervention is to address obstacles to ART uptake/initiation. The proposed work is based in the Information, Motivation, Behavioral Skills ((MB) Model and the intervention will be designed to actively enhance information (e.g. where and how to access care), motivation (e.g. benefits of treatment), and behavioral skills (e.g. problem solving, communication with providers) to increase ART uptake and adherence. Our team has conducted extensive formative research on the topic of treatment expectancies and readiness, including interviews with patients, providers, and the piloting of a preliminary intervention. We now propose to extend this work through the development of a mixed mode intervention based on the content outlined above to be tested in a RCT compared to a lagged intervention condition. The population of interest, those with HIV and low CD4 counts but not taking ART, are more likely to be ethnic and racial minorities, have higher rates of mental illness, substance use, and other barriers to successful management of their HIV. However, they are most likely to die from AIDS-related illness and are at risk of transmitting HIV to others if they do not engage in effective treatment. Our team has experience with such populations and we plan to use recruitment, retention, and assessment protocols demonstrated effective in this context. We will enroll 300 HIV-infected persons not on ART with CD4 <= 250 who will be randomized to immediate or lagged intervention. The intervention will consist of a combination of one-on-one meetings and a single small group session led by cross-disciplinary experts and peers. Booster sessions are proposed to reinforce the intervention. The primary outcome will be initiation (uptake) of ART and secondary outcomes will be ART adherence, CD4, viral load, health status, and morbidity. Follow-up assessments will be conducted at 3, 6, and 12 months with CD4 and viral load at months 0, 6 and 12.