Belzer Marvin E, MacDonell Karen Kolmodin, Ghosh Samiran, Naar Sylvie, McAvoy-Banerjea Julie, Gurung Sitaji, Cain Demetria, Fan Carolyn A, Parsons Jeffrey T
Children's Hospital Los Angeles, Los Angeles, CA, United States.
Department of Family Medicine and Public Health Sciences, Wayne State University School of Medicine, Detroit, MI, United States.
JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183.
Youth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this.
This study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al.
This study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives.
Data collection for this study is projected to begin in August 2018 and last until June 2020.
This is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs.
ClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11183.
13至24岁的感染艾滋病毒青年（YLH）占2016年新增艾滋病毒诊断病例的五分之一以上（21%），但只有27%的YLH实现了病毒抑制。研究表明，YLH对抗逆转录病毒疗法（ART）的依从性较差；然而，关于如何提高YLH依从性的研究有限。移动健康（mHealth）干预可能是实现这一目标的一种有前景的方法。
本研究（ATN[青少年试验网络]144 SMART）旨在比较可提高15至24岁YLH的ART依从性的适应性干预措施。这包括移动健康倡议、干预措施的逐步减少以及激励措施的使用。将确定在提供激励措施之前先进行无激励措施的干预措施排序的成本效益，以及由于病毒载量得到抑制而节省的社会成本。本方案是Naar等人在本期描述的ATN扩大规模计划的一部分。
本研究采用序贯多重分配随机试验设计。大约190名参与者正在被招募、登记并随机分为手机支持组或短信支持组。两个干预组均接受3个月的干预，然后根据对干预的反应进行第二次随机分组。有反应者测试逐步减少干预措施，无反应者测试接受激励措施。
本研究的数据收集预计于2018年8月开始，持续至2020年6月。
这是一项创新性研究，特别是在研究人群、干预类型、对成本效益的关注以及招募方面。本研究在提高YLH的依从性同时降低长期个人和社会成本方面可能特别有效。
ClinicalTrials.gov NCT03535337；https://clinicaltrials.gov/ct2/show/NCT03535337（由WebCite存档于http://www.webcitation.org/74alXb92z）。
国际注册报告识别码（IRRID）：PRR1-10.2196/11183。
