Adaptive intervention strategies trial for strengthening adherence to antiretroviral HIV treatment among youth

背景在美国，越来越多的年轻人正在感染艾滋病毒。 据估计，2010年有超过12，200名青少年被诊断出感染艾滋病毒，自2008年以来增加了22%（1）。 虽然艾滋病毒可以通过持续的抗逆转录病毒疗法（ART）进行管理，但异常高水平的 需要遵守。我们最近发表的系统性文献综述发现，在21篇文章中， 发表了关于艾滋病毒感染青少年药物依从性的报告数据，其中7份描述了试点 干预措施，以提高药物治疗的依从性;只有两个利用教育/咨询会议， 促进依从性技能的培养-这是提高依从性的必要组成部分 感染艾滋病毒的成年人。据我们所知，目前尚无已证实有效的ART依从性 到目前为止，艾滋病毒感染青少年的干预措施。这一点尤其令人担忧，因为 青少年的依从性通常是次优的。提案概述。这一提议是 对该人群进行了6年的形成性研究，包括进行了两项试点随机对照试验 （RCT）。目前的研究是为了测试一种阶梯式护理“适应性”ART依从性干预的有效性 （“积极步骤”），为艾滋病毒感染的青少年，年龄16至24岁。阶梯式护理是一种医疗保健提供模式， 首先提供干预措施中资源密集度最低的部分，只提供那些没有改善的部分， 然后接受高强度、资源更密集的干预部分。概念模型。的 概念模型是基于我们的形成性工作，导致了理论驱动的发展 干预课程（“积极步骤”），立足于艾滋病毒感染者的社会和背景现实， 青少年。我们的干预始于每天双向短信，旨在提高ART依从性。为 许多青少年（超过1/3来自我们的试点RCT），短信不足以克服障碍， 坚持抗逆转录病毒疗法。然后，这些人还将接受基于一般 认知行为疗法的原则信息、解决问题和认知行为“步骤”是 处理超过5个，在人，干预咨询会议（包括数字视频小插曲， 具体针对青少年面临的依从性挑战）。研究计划概述。192名艾滋病毒感染者 年龄在16至24岁之间的青少年和处方ART将在美国两个主要城市招募， 和研究经验。受试者将被平等随机分配至：（1）“阳性 STEPS”-一种阶梯式护理，采用综合技术和咨询的依从性干预;或（2）标准 护理对照组。将在随机化后对受试者进行为期一年的随访。主 结果是ART依从性测量的改善（即，Wisepill、HIV病毒载量和自我报告）; 次要结果包括CD 4细胞计数、HIV症状和生活质量的改善。

Background. A significant and growing population of young people are acquiring and living with HIV in the US. An estimated >12,200 adolescents were diagnosed with HIV infection in 2010, a 22% increase since 2008(1). Although HIV can be managed with ongoing antiretroviral therapy (ART), exceptionally high levels of adherence are required. Our recently published systematic literature review found that of the 21 articles published that reported data on medication adherence in HIV infected adolescents, seven described pilot interventions to enhance medication adherence; and only two utilized education / counseling sessions to promote adherence skills-building – a component that has shown to be necessary to improving adherence among HIV-infected adults. To our knowledge, there are no demonstrated efficacious ART adherence interventions for HIV infected adolescents to date. This is particularly concerning given that overall rates of adherence among adolescents is generally suboptimal. Overview of Proposal. This proposal is culmination of 6 years of formative work with this population, including conducting two pilot randomized controlled trials (RCT). The current study is to test the efficacy of a stepped-care “adaptive” ART adherence intervention (“Positive STEPS”) for HIV infected adolescents, ages 16 to 24. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who do not improve then receive the high intensity, more resource intensive part of an intervention. Conceptual Model. The conceptual model is based on our formative work that led to the development of a theoretically-driven intervention curriculum (“Positive STEPS”), grounded in the social and contextual realities of HIV infected adolescents. Our intervention begins with 2-way daily text messaging aimed at improving ART adherence. For many adolescents (over 1/3 from our pilot RCT), text messaging is not sufficient to overcome the barriers to ART adherence. These individuals will then also receive the more intensive component based on general principles of cognitive-behavioral therapy. Informational, problem solving, and cognitive-behavioral “steps” are addressed over 5, in-person, intervention-counseling sessions (incorporating digital video vignettes that are specific to the adherence challenges faced by adolescents). Overview of Research Plan. 192 HIV infected adolescents, aged 16 to 24, and prescribed ART will be recruited in two major U.S. cities with excellent access to and research experience with the population. Participants will be equally randomized to: (1) “Positive STEPS” – a stepped care, adherence intervention with integrated technology and counseling; or (2) Standard of Care comparison group. Participants will be followed for one-year post-randomization. The primary outcomes are improvements in measures of ART adherence (i.e., Wisepill, HIV viral load, and self report); secondary outcomes include improvements in CD4 cell count, HIV symptoms, and quality of life.