Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

描述（申请人提供）：尽管抗逆转录病毒疗法（ART）对艾滋病毒疾病的广泛可用性和有效性，但仍有大量患有晚期疾病的人没有接受治疗，并且由于未能获得ART而死亡的艾滋病毒+患者数量惊人。拟议研究的目的是开发和测试一种干预措施，以准备艾滋病毒+男性和女性，根据目前的治疗指南，应该但目前没有服用ART。这一系列研究的首要目标是防止由于未能获得ART而导致的不必要的死亡，并且所提出的干预措施的直接目标是解决ART摄取/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，干预措施将旨在积极加强信息（例如在哪里和如何获得护理）、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），以增加抗逆转录病毒疗法的使用和坚持。我们的团队对治疗预期和准备情况这一主题进行了广泛的形成性研究，包括采访患者、提供者以及初步干预措施的试点。我们现在建议通过开发基于上述内容的混合模式干预来扩展这项工作，与滞后干预条件相比，在RCT中进行测试。感兴趣的人群，那些艾滋病毒和低CD 4计数，但不采取抗逆转录病毒治疗，更有可能是少数民族和种族，有较高的精神疾病，药物使用率和其他障碍，以成功管理他们的艾滋病毒。然而，他们最有可能死于与艾滋病有关的疾病，如果不进行有效治疗，他们就有可能将艾滋病毒传染给他人。我们的团队有与这些人群打交道的经验，我们计划使用在这种情况下证明有效的招募、保留和评估协议。我们将招募300名未接受抗逆转录病毒治疗且CD 4 <= 250的HIV感染者，他们将被随机分配到立即或延迟干预组。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。有人建议举行加强会议，以加强干预。主要结局将是ART的开始（摄取），次要结局将是ART依从性、CD 4、病毒载量、健康状况和发病率。 将在第3、6和12个月进行随访评估，并在第0、6和12个月进行CD 4和病毒载量评估。

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.