随机对照试验方案：WiseApp 试验改善 PLWH 健康结局（WiseApp）。
Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp).
机构信息
College of Public Health, University of South Florida, 13201 Bruce B. Downs Blvd, Tampa, FL, 33612, USA.
Division of Scholarship and Research, Columbia University School of Nursing, 560 West 168th Street, New York, NY, 10032, USA.
出版信息
BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0.
BACKGROUND
Poor adherence to antiretroviral therapy (ART) is one of the primary barriers to viral load suppression. mHealth technology can help overcome challenges with ART adherence. This paper outlines the protocol for the WiseApp randomized control trial. The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) self-manage their medication adherence and improve their overall quality of life. The primary objective of the trial is to test the effect of the WiseApp's medication adherence features on antiretroviral adherence in underserved PLWH in New York City.
METHODS
This ongoing study is a two-arm randomized control trial. Participants are randomized 1:1 to the WiseApp intervention arm or the control arm at baseline and followed for 6 months. Eligibility criteria include: 18 years of age, have a diagnosis of HIV, speak and understand English or Spanish, live in the United States, own a smartphone, currently taking ART medications, and report the past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL. The sample size for the trial is 200 people. All study participants receive the WiseApp, a CleverCap electronic pill bottle, and a fitness tracker. The intervention group also receives videos and health surveys centered on medication adherence and managing living with HIV as well as medication reminders. In contrast, the control group receives walk step reminders, videos, and surveys focused on overall wellness.
DISCUSSION
The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth medication adherence and HIV self-management application in the United States. The trial could also bring new opportunities for advancement in reaching economically disenfranchised and underserved populations in the United States. The real-time monitoring of the WiseApp has the potential to help providers initiate interventions to help patients resume treatment before drug resistance begins.
TRIAL REGISTRATION
This trial was registered with ClinicalTrials.gov ( NCT03205982 ) on July 2, 2017.
背景
抗逆转录病毒疗法（ART）依从性差是病毒载量抑制的主要障碍之一。移动医疗技术可以帮助克服 ART 依从性方面的挑战。本文概述了 WiseApp 随机对照试验的方案。WiseApp 包含实时药物监测，将电子药瓶和健身追踪器与应用程序连接起来，帮助艾滋病毒感染者（PLWH）自我管理药物依从性并提高整体生活质量。试验的主要目的是测试 WiseApp 的药物依从性功能对纽约市服务不足的 PLWH 抗逆转录病毒依从性的影响。
方法
这项正在进行的研究是一项两臂随机对照试验。参与者在基线时按 1:1 随机分配到 WiseApp 干预组或对照组，并随访 6 个月。入选标准包括：年龄 18 岁，诊断为 HIV，会说并理解英语或西班牙语，居住在美国，拥有智能手机，目前正在服用 ART 药物，且过去 30 天内使用视觉模拟量表（VAS）报告的依从率为 80%或更低，或病毒载量超过 400 拷贝/ml。试验的样本量为 200 人。所有研究参与者都将获得 WiseApp、CleverCap 电子药瓶和健身追踪器。干预组还将获得以药物依从性和管理 HIV 感染为中心的视频和健康调查，以及药物提醒。相比之下，对照组将获得步行步骤提醒、视频和以整体健康为重点的调查。
讨论
WiseApp 试验有可能改善 HIV 自我管理应用程序，这是美国少数几个关于移动医疗药物依从性和 HIV 自我管理应用程序的随机对照试验之一。该试验还可能为在美国为经济上处于不利地位和服务不足的人群带来新的机会。WiseApp 的实时监测有可能帮助提供者在开始耐药之前启动干预措施，帮助患者恢复治疗。
试验注册
该试验于 2017 年 7 月 2 日在 ClinicalTrials.gov（NCT03205982）注册。
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