Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp).
Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp).
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DOI：
10.1186/s12889-020-09688-0
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发表时间：
2020-11-25
影响因子：
4.5
通讯作者：
Schnall R
中科院分区：
文献类型：
--
作者：
Flynn G;Jia H;Reynolds NR;Mohr DC;Schnall R
抗逆转录病毒治疗（ART）依从性差是抑制病毒载量的主要障碍之一。移动医疗技术可以帮助克服ART依从性的挑战。本文概述了WiseApp随机对照试验的方案。WiseApp包含实时药物监测，将电子药瓶和健身跟踪器连接到应用程序，帮助艾滋病毒感染者（PLWH）自我管理他们的药物依从性并提高他们的整体生活质量。该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。这项正在进行的研究是一项两组随机对照试验。参与者在基线时以1：1的比例随机分配至WiseApp干预组或对照组，并随访6个月。资格标准包括：18岁，诊断为HIV，能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，并报告过去30天的依从性为80%或更低（使用视觉焦虑量表（VAS）测量），或病毒载量超过400拷贝/mL。试验的样本量为200人。所有研究参与者都会收到WiseApp、CleverCap电子药瓶和健身追踪器。干预小组还收到以药物依从性和管理艾滋病毒感染者为中心的视频和健康调查以及药物提醒。相比之下，对照组收到步行步骤提醒，视频和调查集中在整体健康。WiseApp试验有可能改善艾滋病毒自我管理应用程序，是美国为数不多的mHealth药物依从性和艾滋病毒自我管理应用程序的随机对照试验之一。该试验还可能为美国经济上被剥夺权利和服务不足的人群带来新的进步机会。WiseApp的实时监测有可能帮助提供者启动干预措施，帮助患者在耐药性开始之前恢复治疗。本试验于2017年7月2日在ClinicalTrials.gov（NCT 03205982）上注册。
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. 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. 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. This trial was registered with ClinicalTrials.gov (NCT03205982) on July 2, 2017.
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影响因子：
15.8
作者：
Mills EJ;Nachega JB;Bangsberg DR;Singh S;Rachlis B;Wu P;Wilson K;Buchan I;Gill CJ;Cooper C
通讯作者：
Cooper C
影响因子：
5.5
作者：
Kumar, Santosh;Nilsen, Wendy J.;Abernethy, Amy;Atienza, Audie;Patrick, Kevin;Pavel, Misha;Riley, William T.;Shar, Albert;Spring, Bonnie;Spruijt-Metz, Donna;Hedeker, Donald;Honavar, Vasant;Kravitz, Richard;Lefebvre, R. Craig;Mohr, David C.;Murphy, Susan A.;Quinn, Charlene;Shusterman, Vladimir;Swendeman, Dallas
通讯作者：
Swendeman, Dallas
DOI：
10.2174/1874613620130812003
发表时间：
2013
期刊：
The open AIDS journal
影响因子：
--
作者：
Catalani C;Philbrick W;Fraser H;Mechael P;Israelski DM
通讯作者：
Israelski DM
DOI：
10.1080/09540120500465160
发表时间：
2006-10-01
影响因子：
1.7
作者：
Mannheimer, S. B.;Mukherjee, R.;Finkelstein, R.
通讯作者：
Finkelstein, R.
DOI：
10.1016/j.ijmedinf.2018.11.012
发表时间：
2019-02-01
影响因子：
4.9
作者：
Beauchemin, Melissa;Gradilla, Melissa;Schnall, Rebecca
通讯作者：
Schnall, Rebecca