Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

描述（由申请人提供）：尽管针对艾滋病毒疾病的抗逆转录病毒疗法（ART）广泛可用且有效，但仍有大量晚期疾病患者没有接受治疗，并且由于未能获得抗逆转录病毒疗法而死亡的艾滋病毒阳性患者数量惊人。拟议研究的目的是开发和测试一种干预措施，以使艾滋病毒阳性的男性和女性做好准备，根据目前的治疗指南，他们应该但目前没有服用抗逆转录病毒药物。这一研究方向的总体目标是防止由于无法获得抗逆转录病毒治疗而导致的不必要死亡，而拟议干预措施的直接目标是解决抗逆转录病毒治疗接受/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加强信息（例如，在哪里以及如何获得护理）、动机（例如，治疗的益处）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治疗的接受和坚持。我们的团队对治疗预期和准备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述内容的混合模式干预来扩展这项工作，该干预将在RCT中进行测试，与滞后干预条件进行比较。感兴趣的人群，即艾滋病毒感染者和CD4细胞计数低但未接受抗逆转录病毒治疗的人群，更有可能是少数民族和种族，他们的精神疾病、药物使用率和其他成功管理艾滋病毒的障碍的比例更高。然而，他们很可能死于与艾滋病有关的疾病，如果不进行有效治疗，他们有将艾滋病毒传染给他人的危险。我们的团队有处理此类人群的经验，我们计划使用在此背景下证明有效的招聘、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CD4 <= 250的艾滋病毒感染者，他们将随机分为立即干预组或滞后干预组。干预措施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。建议举行辅助性会议以加强干预。主要结局是开始（接受）抗逆转录病毒治疗，次要结局是抗逆转录病毒治疗依从性、CD4、病毒载量、健康状况和发病率。随访评估将在第3,6和12个月进行，CD4和病毒载量在第0,6和12个月。

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.