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

加强青少年抗逆转录病毒艾滋病毒治疗依从性的适应性干预策略试验

• 批准号: 10371803
• 负责人: Robert Garofalo
• 金额: $ 59.15万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-26 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10371803
• 关键词: Adaptive; intervention; strategies; trial; strengthening

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.

背景：在美国，有大量年轻人感染艾滋病毒并与艾滋病毒一起生活，而且这一人数还在不断增加。 2010 年估计有超过 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治疗（ART）来控制，但异常高水平的 我们最近发表的系统文献综述发现，在 21 篇文章中，坚持是必需的。 发表报告了艾滋病毒感染青少年的药物依从性数据，七名描述了试点 提高药物依从性的干预措施；并且仅利用两次教育/咨询课程来提高药物依从性； 促进技能依从性建设——事实证明这是提高依从性所必需的一个组成部分 据我们所知，在感染艾滋病毒的成年人中，尚无有效的抗逆转录病毒疗法依从性。 迄今为止，针对艾滋病毒感染青少年的干预措施尤其令人担忧。 提案概述 该提案是遵守情况的顶峰。 对这一人群进行了 6 年的形成性工作，包括进行两项试点随机对照试验 （随机对照试验）。当前的研究旨在测试阶梯式护理“适应性”ART 依从性干预的有效性。 （“Positive STEPS”）针对 16 至 24 岁的 HIV 感染青少年。阶梯式护理是一种医疗保健提供模式 首先实施干预措施中资源最少的部分，并且只有那些没有改善的部分 然后接受概念模型中高强度、资源密集的部分。 概念模型基于我们的形成性工作，这些工作导致了理论驱动的发展 干预课程（“积极步骤”），以艾滋病毒感染者的社会和背景现实为基础 我们的干预措施从每天两次短信开始，旨在提高 ART 的依从性。 对于许多青少年（我们的试点随机对照试验中超过 1/3 的青少年）来说，短信不足以克服障碍 然后，这些人还将接受基于一般情况的更强化的组成部分。 认知行为治疗的原则是信息、问题解决和认知行为“步骤”。 进行了超过 5 场面对面的干预咨询会议（包括数字视频片段） 具体针对青少年面临的依从性挑战）。192 HIV 感染者的研究计划概述。 将在美国两个交通便利的主要城市招募接受 ART 治疗的 16 至 24 岁青少年 参与者的研究经验将被同等地随机分配到：（1）“积极的”。 STEPS”——采用综合技术和咨询的阶梯式护理、依从性干预；或 (2) 标准 护理对照组的参与者将在随机分组后进行一年的随访。 结果是 ART 依从性指标的改善（即 Wisepill、HIV 病毒载量和自我报告）； 次要结果包括 CD4 细胞计数、艾滋病毒症状和生活质量的改善。

项目成果

Positive STEPS - a randomized controlled efficacy trial of an adaptive intervention for strengthening adherence to antiretroviral HIV treatment among youth: study protocol.

Positive STEPS - 一项针对加强青少年抗逆转录病毒 HIV 治疗依从性的适应性干预的随机对照疗效试验：研究方案。

• 发表时间: 2018-07-13
• 影响因子: 4.5
• 作者: Mimiaga, Matthew J;Kuhns, Lisa M;Biello, Katie B;Olson, Jennifer;Hoehnle, Sam;Santostefano, Christopher M;Hughto, Jaclyn M W;Safi, Hadeis;Salhaney, Peter;Chen, Diane;Garofalo, Robert
• 通讯作者: Garofalo, Robert