积极的步骤:加强药物依从性和实现病毒载量抑制在美国的青年艾滋病毒感染者-从一个循序渐进的随机对照疗效试验的结果。

IF 2.9 3区 医学 Q3 IMMUNOLOGY
Matthew J Mimiaga, Lisa M Kuhns, Katie B Biello, Jiahao Tian, Margie R Skeer, Christina Psaros, Ethan Moitra, Diane Chen, Elizabeth Yonko, Kenneth H Mayer, Steven A Safren, Robert Garofalo
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引用次数: 0

摘要

背景:在美国和世界范围内,有相当数量的年轻人感染艾滋病毒。抗逆转录病毒疗法大大减少了与艾滋病毒有关的疾病和死亡,使感染艾滋病毒的年轻人能够将自己的病情作为一种慢性病加以管理。确保高水平的抗逆转录病毒治疗依从性对治疗成功至关重要。尽管如此,据我们所知,目前还没有有效的行为干预措施来改善美国年轻人抗逆转录病毒治疗的依从性和病毒抑制。我们在波士顿、马萨诸塞州普罗维登斯、罗德岛和伊利诺斯州的芝加哥进行了一项多城市随机对照试验,以检验与标准护理(SOC)对照相比,逐步护理、行为和基于技术的干预“Positive STEPS”在改善16至29岁艾滋病毒感染者的抗逆转录病毒治疗依从性和病毒抑制方面的效果。积极步骤包括:第一步:TXTXT,一种基于证据的每日双向个性化短信,提醒人们服用抗逆转录病毒药物;在2018年3月至2023年3月期间,123名参与者被随机化(Positive STEPS = 63;SOC控制= 60)。意向治疗分析显示,positive STEPS组具有显著的正主效应,在4个月的随访中,相对于SOC对照组,其平均对数ART依从性增加了18.7%(系数=0.187,p=0.021)。对于时间效应,在随后的随访中观察到ART依从性的显着总体增加,平均对数ART依从性增加了27.8% (p)。这些关于Positive STEPS提高艾滋病毒感染者抗逆转录病毒治疗依从性和病毒抑制效果的研究结果,代表了首次对与抗逆转录病毒治疗依从性相关的行为(Wisepill和自我报告)和生物医学(HIV病毒载量)结果显示显着和持续影响的青少年行为干预。与对照组相比,干预不仅显示出显著的效果,而且在12个月的时间内保持了收益。有效性和实施科学的方法来测试积极步骤在现实世界的设置建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Positive STEPS: Enhancing Medication Adherence and Achieving Viral Load Suppression in Youth Living With HIV in the United States-Results From an Efficacious Stepped Care, Randomized Controlled Trial.

Background: In the United States and worldwide, there is a significant number of young people acquiring and living with HIV. Antiretroviral therapy (ART) has led to significant reductions in HIV-related illnesses and deaths, allowing young people living with HIV to manage their condition as a chronic disease. Ensuring high levels of ART adherence is vital for treatment success. Despite this, to the best of our knowledge, there are no efficacious behavioral interventions for improving ART adherence and viral suppression among youth in the United States.

Methods: We conducted a multicity, randomized, controlled trial-in Boston, MA/Providence, RI and Chicago, IL-to examine the efficacy of an stepped care, behavioral and technology-based intervention, "Positive STrategies to Enhance Problem-Solving Skills (Positive STEPS)," compared with a standard of care (SOC) control, for improving ART adherence and viral suppression among youth living with HIV ages 16-29 years. Positive STEPS included the following: step 1: TXTXT, an evidence-based, daily 2-way personalized text message reminder to take ART medications; step 2: only participants with <90% adherence anytime between weeks 5 and 12 postrandomization to the Positive STEPS arm would then receive five 50-minute sessions of manualized individual adherence counseling. If participants' adherence remained at ≥90% , then they did not progress to step 2. ART adherence was measured via Wisepill, an electronic medication monitoring device, and self-report. Participants were followed for 12 months and completed biospecimen collection (HIV plasma RNA viral load testing) and a quantitative assessment battery at baseline and at their 4-, 8-, and 12-month follow-up visits.

Results: Between March 2018 and March 2023, 123 participants were randomized (Positive STEPS = 63; SOC control = 60). Intention-to-treat analyses showed a significant positive main effect for the Positive STEPS arm, which increased the mean log ART adherence by 18.7% relative to the SOC control at the 4-month visit (coefficient = 0.187, P = 0.021). For the time effect, a significant overall increase in ART adherence across the subsequent follow-up visits was observed, with increased mean log ART adherence by 27.8% ( P < 0.01) at 8 months and 30.1% at 12 months ( P < 0.01), relative to the SOC control. With respect to our viral suppression outcome, the analysis revealed a significant negative main effect for the Positive STEPS arm at 4-months (odds ratio = 0.264, P = 0.023), indicating that the odds of having an unsuppressed virus were 74% lower in the Positive STEPS arm compared with the SOC control; the interaction term revealed that this effect was maintained through the 12-month follow-up time period.

Conclusion: These findings on the efficacy of Positive STEPS to enhance ART adherence and viral suppression among youth living with HIV represent the first behavioral intervention for youth to show significant and sustained effects on both behavioral (Wisepill and self-report) and biomedical (HIV viral load) outcomes related to ART adherence. The intervention not only demonstrated remarkable efficacy when compared with the SOC control but also showed maintenance of gains over a 12-month period. Effectiveness and implementation science approaches to testing positive STEPS in real-world settings is recommended.

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来源期刊
CiteScore
5.80
自引率
5.60%
发文量
490
审稿时长
3-6 weeks
期刊介绍: JAIDS: Journal of Acquired Immune Deficiency Syndromes​ seeks to end the HIV epidemic by presenting important new science across all disciplines that advance our understanding of the biology, treatment and prevention of HIV infection worldwide. JAIDS: Journal of Acquired Immune Deficiency Syndromes is the trusted, interdisciplinary resource for HIV- and AIDS-related information with a strong focus on basic and translational science, clinical science, and epidemiology and prevention. Co-edited by the foremost leaders in clinical virology, molecular biology, and epidemiology, JAIDS publishes vital information on the advances in diagnosis and treatment of HIV infections, as well as the latest research in the development of therapeutics and vaccine approaches. This ground-breaking journal brings together rigorously peer-reviewed articles, reviews of current research, results of clinical trials, and epidemiologic reports from around the world.
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