mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial.

mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial.
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移动健康干预,以改善艾滋病毒使用者的治疗结果:试点随机对照试验方案。

DOI:
10.2196/28332
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发表时间:
2022-03-07
影响因子:
1.7
通讯作者:
Altice FL
Altice FL
中科院分区:
其他
文献类型:
--
作者:
Ranjit YS;Krishnan A;Ghosh D;Cravero C;Zhou X;Altice FL

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抗逆转录病毒疗法可有效降低艾滋病毒相关的发病率、死亡率和艾滋病毒感染者的传播。然而,坚持和坚持抗逆转录病毒治疗是艾滋病毒治疗取得成功的关键。使用可卡因的艾滋病毒感染者难以获得艾滋病毒服务,继续接受护理的人数也较少。本文的主要目标是详细描述移动的健康干预措施。这项研究旨在改善使用可卡因的艾滋病毒感染者的药物依从性。第二个目标是列出研究设计中包含的重要挑战和调整。这项名为Project SMART的研究使用了一种基于无线技术的干预措施,包括名为TowerView Health的蜂窝电子药盒和智能手机,以提供有关依从行为的提醒和反馈。干预设计是基于自我决定理论和动机技术模型提供的理论框架。为期12周的四组随机对照试验提供了三种类型的反馈:自动反馈,自动+临床医生反馈和自动反馈+社交网络反馈。该研究于2016年8月1日由国家药物滥用研究所(R21 DA 039842)资助。该研究的机构审查委员会于2017年3月21日获得耶鲁大学的批准。数据收集时间为2017年6月至2020年1月。最终招募了71名参与者,其中57名(80%)完成了研究。目前正在对数据进行分析,并正在编写手稿,以便在2022年初出版。为高风险和边缘化人群实施复杂的移动的健康干预措施,包括多方面的干预措施,带来了一定的挑战,例如寻找拥有足够客户技术和财务稳定性的公司,以及最大限度地减少研究人群的研究相关负担。进行可行性研究对于认识这些挑战以及通过解决方案解决这些挑战的机会非常重要,同时保持随机对照试验的设计尽可能真实。Clinicaltrials.gov NCT 04418076; https://clinicaltrials.gov/ct2/show/NCT04418076 DERR 1 -10.2196/28332
Antiretroviral therapy is effective in reducing HIV-related morbidity, mortality, and transmission among people with HIV. However, adherence and persistence to antiretroviral therapy are crucial for successful HIV treatment outcomes. People with HIV who use cocaine have poor access to HIV services and lower retention in care. The primary goal of this paper is to provide a detailed description of a mobile health intervention. This study is designed to improve medication adherence among people with HIV who use cocaine. A secondary goal is to list the important challenges and adaptations incorporated in the study design. This study, titled Project SMART, used a wireless technology–based intervention, including cellular-enabled electronic pillboxes called TowerView Health and smartphones, to provide reminders and feedback on adherence behavior. The intervention design was based on the theoretical frameworks provided by the self-determination theory and the Motivation Technology Model. The 12-week pilot randomized controlled trial with four arms provided three types of feedback: automated feedback, automated+clinician feedback, and automated feedback+social network feedback. The study was funded by the National Institute of Drug Abuse (R21DA039842) on August 1, 2016. The institutional review board for the study was approved by Yale University on March 21, 2017. Data collection lasted from June 2017 to January 2020. The final enrollment was 71 participants, of whom 57 (80%) completed the study. The data are currently undergoing analysis, and the manuscript is being developed for publication in early 2022. Implementing complex mobile health interventions for high-risk and marginalized populations with multicomponent interventions poses certain challenges, such as finding companies with adequate technology for clients and financial stability and minimizing the research-related burden for the study population. Conducting feasibility studies is important to recognize these challenges and the opportunity to address these challenges with solutions while keeping the design of a randomized controlled trial as true as possible. Clinicaltrials.gov NCT04418076; https://clinicaltrials.gov/ct2/show/NCT04418076 DERR1-10.2196/28332
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