A SMART trial evaluating phased implementation of text messaging, cell phone support, and contingency management in youth nonadherent to antiretroviral medication

一项 SMART 试验，评估对不遵守抗逆转录病毒药物治疗的青少年分阶段实施短信、手机支持和应急管理的情况

• 批准号: 9980432
• 负责人: MARVIN E BELZER
• 金额: $ 16.89万
• 依托单位: FLORIDA STATE UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2022-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9980432
• 关键词: Address; Adherence; Adolescent; Adolescent Medicine Trials Network; Adolescent and Young Adult; Age; Age-Years; Alcohol or Other Drugs use; Anti-Retroviral Agents; Behavioral; Caring; Cellular Phone; Chronic Disease; Clinical; Clinical Trials; Collaborations; Data; Detection; Disease Progression; Dose; Effectiveness; Electronics; Elements; Evaluation; Funding; Goals; HIV; HIV Infections; HIV diagnosis; HIV-infected adolescents; Health Promotion; Health Services; Health Technology; Human; Hybrids; Incentives; Individual; Intervention; Interview; Measurement; Mediating; Mental Depression; Meta-Analysis; Methodology; Methods; Modeling; Morbidity - disease rate; North America; Participant; Patient Self-Report; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Randomized; Research; Research Personnel; Route; Self Management; Sequential Multiple Assignment Randomized Trial; Social support; Surveys; Text Messaging; Therapeutic; Time; Treatment Effectiveness; United States; United States National Institutes of Health; Viral Load result; Visit; Voice; Youth; adherence rate; antiretroviral therapy; base; behavioral health; clinical care; clinical research site; contingency management; cost; cost effective; cost effectiveness; cost efficient; effectiveness trial; experience; follow-up; implementation research; improved; intervention effect; mHealth; medication compliance; mortality; pilot trial; portability; post intervention; primary outcome; recruit; relative cost; relative effectiveness; responders and non-responders; response; secondary outcome; standard care; therapy adherence; therapy design; treatment effect; trial comparing; trial design; virology

In the United States, it is estimated that one-third of all new HIV diagnoses are among people less than 25 years of age. There is strong evidence that adherence to ART is a primary determinant of virological suppression, disease progression, and mortality. However, a recent review and metaanalysis of research on youth with HIV found an average ART adherence rate of 53% in North America, the lowest adherence rate globally. Intensive and/or in-person adherence intervention models have been problematic for youth with HIV. Interventions requiring multiple visits, even with brief, in-person sessions, have been difficult for youth to complete. These models have largely failed to promote long-term, sustained medication adherence (and sustained viral load below detection), and are commonly cost prohibitive for use in real world settings regardless of efficacy. Given these issues, one possibility for sustainable, yet individualized intervention delivery is through mobile health/technology-based approaches. This proposal directly addresses the urgent need for culturally acceptable, youth-friendly ART adherence interventions that can be rapidly implemented in clinical settings. We plan to conduct a clinical trial comparing two promising youth-friendly intervention strategies: weekday cell phone support (CPS) and daily text messaging (SMS). In pilot studies, both have demonstrated significant improvements in medication adherence. Participants who received CPS showed significant reductions in HIV viral load during the 24 week intervention; moreover, effects persisted for 24 weeks post intervention. The proposed research moves beyond a traditional clinical trial by utilizing a “SMART” (Sequential Multiple Assignment Randomized Trial) design as a cost-effective and methodologically rigorous way to explore additional questions to optimize the interventions and maximize clinical utility and real-world implementation. This SMART design will allow us to identify the most effective and cost efficient sequence of SMS and/or CPS, utilizing incentives strategically, and tapering to sustain the impact of the intervention. We hypothesize that youth randomized to CPS will have significantly greater viral load suppression (primary outcome) and self-reported medication adherence (secondary outcome) than those in the SMS group. The proposed research brings together a team of skilled HIV clinical and behavioral researchers with decades of experience with clinical care and adherence research with youth, including numerous collaborations within the NIH-funded Adolescent Trials Network. This research will be conducted at five clinical sites with decades of experience conducting trials and that have a track record of excellence in recruiting, retaining, and collecting data from youth living with HIV.

在美国，据估计，所有新的艾滋病毒诊断中有三分之一是在较少的人中 超过25岁。有强有力的证据表明，遵守艺术是 病毒学抑制，疾病进展和死亡率。但是，最近的评论和荟萃分析 在艾滋病毒青年的研究中，北部的平均艺术依从率为53％ 美国，全球最低的依从性率。密集和/或面对面的依从性干预 模型对于艾滋病毒青年来说是有问题的。即使有多次访问的干预措施，即使 简短的，面对面的会议很难让青年完成。这些模型在很大程度上失败了 为了促进长期的持续药物依从性（在检测到以下的病毒载量持续的病毒载荷）， 并且通常禁止在现实世界中使用成本，而不论轻松。鉴于这些 问题，可持续但个性化的干预交付的一种可能性是通过移动 基于健康/技术的方法。该提议直接解决了对文化的迫切需求 可以在临床上快速实施的可接受的，对青年友好的艺术依从性干预措施 设置。我们计划进行一项临床试验，比较两项承诺对青年友好的干预措施 策略：工作日手机支持（CPS）和每日文本消息（SMS）。在试点研究中，两者都 已经显示出药物依从性的显着改善。收到的参与者 在24周干预期间，CPS显示出HIV病毒负荷的显着降低；而且， 干预后24周效果持续了24周。拟议的研究超越了传统 通过使用“智能”（顺序多重分配随机试验）设计的临床试验作为一个 具有成本效益和方法论上严格的方式来探索其他问题，以优化 干预措施并最大化临床实用性和现实世界实施。这个智能设计将 让我们使用SMS和/或CP的最有效，最有效的序列，使用 策略性的激励措施，并逐渐减少干预措施的影响。我们假设这一点 随机分配到CP的青年将具有更大的病毒载荷抑制作用（主要结果） 与SMS组中的药物依从性（次要结果）相比。这 拟议的研究将一组熟练的艾滋病毒临床和行为研究人员与 数十年的临床护理和与青年依从性研究的经验，包括许多 NIH资助的青少年试验网络中的合作。这项研究将在 五个临床站点，具有数十年的经验进行试验，并且具有记录 卓越的招募，保留和收集艾滋病毒青年的数据。