iVY: protocol for a randomised clinical trial to test the effect of a technology-based intervention to improve virological suppression among young adults with HIV in the USA.
iVY: protocol for a randomised clinical trial to test the effect of a technology-based intervention to improve virological suppression among young adults with HIV in the USA.
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DOI：
10.1136/bmjopen-2023-077676
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发表时间：
2023-10-06
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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感染艾滋病毒的年轻人（YWH）的临床结果比成年人更差，并且药物使用（SU）和精神疾病的发生率很高，这影响了他们对护理的参与和对抗逆转录病毒治疗（ART）的坚持。青少年病毒学抑制干预措施（iVY）旨在采用适合青少年的差异化护理方法，以量身定制的方式解决治疗参与/依从性、心理健康（MH）和SU问题。研究结果将提供有关iVY对HIV病毒学抑制，MH和SU在YWH中的影响的信息，YWH受HIV影响不成比例，并且健康状况不佳的风险较高。iVY研究将在200名YWH（18-29岁）中采用适应性治疗策略的随机临床试验中，测试基于技术的干预措施在不同资源需求水平（即财务和人员时间）下的效果。主要结果是通过干血斑测量的HIV病毒学抑制。这种试点和协议化的干预措施结合了：（1）通过视频聊天平台（视频咨询）每周与咨询师进行简短的会议，讨论MH、SU、艾滋病毒护理参与/坚持和其他护理障碍;（2）移动的健康应用程序，以解决ART遗忘和社会孤立等障碍。iVY有可能解决重要的，独特的和不断变化的障碍，艾滋病毒护理参与（如MH，SU），以增加病毒学抑制青年妇女在高风险的健康状况不佳的结果。本研究及其方案已获得加州大学弗朗西斯科分校机构审查委员会的批准。研究工作人员将与青年顾问小组合作，向青年工作者、参与者和学术界传播研究结果。 NCT 05877729。
Young adults with HIV (YWH) experience worse clinical outcomes than adults and have high rates of substance use (SU) and mental illness that impact their engagement in care and adherence to antiretroviral therapy (ART). The intervention for Virologic Suppression in Youth (iVY) aims to address treatment engagement/adherence, mental health (MH) and SU in a tailored manner using a differentiated care approach that is youth friendly. Findings will provide information about the impact of iVY on HIV virological suppression, MH and SU among YWH who are disproportionately impacted by HIV and at elevated risk for poor health outcomes. The iVY study will test the effect of a technology-based intervention with differing levels of resource requirements (ie, financial and personnel time) in a randomised clinical trial with an adaptive treatment strategy among 200 YWH (18–29 years old). The primary outcome is HIV virological suppression measured via dried blood spot. This piloted and protocolised intervention combines: (1) brief weekly sessions with a counsellor via a video-chat platform (video-counselling) to discuss MH, SU, HIV care engagement/adherence and other barriers to care; and (2) a mobile health app to address barriers such as ART forgetfulness, and social isolation. iVY has the potential to address important, distinct and changing barriers to HIV care engagement (eg, MH, SU) to increase virological suppression among YWH at elevated risk for poor health outcomes. This study and its protocols have been approved by the University of California, San Francisco Institutional Review Board. Study staff will work with a Youth Advisory Panel to disseminate results to YWH, participants and the academic community. NCT05877729.
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