Comprehensive, tailored, technology-based intervention to improve virologic suppression among youth and young adults living with HIV

摘要/项目摘要： 在美国，青少年和青年艾滋病毒携带者(YLWH)的抗逆转录病毒治疗(ART)率较低 启动、次佳的ART依从性和在护理中的保留，以及较高的病毒学失败率 年龄较大的群体。此外，物质依赖、精神障碍和 年龄越小，使用药物的风险越大，死亡率越高。精神健康(MH)和物质使用(SU) 影响艾滋病毒护理连续过程的每一步，从诊断到病毒抑制，并加剧 联系和可持续获得医疗保健的社会经济挑战。鉴于有强有力的证据证明 MH和SU对不良的艾滋病毒健康结局的影响，显然需要增加获得和 提供这些服务。尽管需要解决妇女健康院护理方面的这些关键障碍，但仍存在 全国MH专业人员严重短缺，缺乏针对这一年龄段的干预措施。 与非营利性艾滋病保健基金会(最大的艾滋病毒护理提供者)和一个 青年咨询小组，拟议的研究旨在以量身定制的方式利用 差别化护理方法是“对青年友好的”。我们的目标是测试量身定做的基于技术的 对200名长寿妇女采用适应性治疗策略的随机临床试验(RCT)的干预 (18-29岁)。干预措施包括：(1)每周与辅导员进行简短的咨询会议，讨论 MH、SU、HIV关怀参与度和通过视频聊天平台提供的其他护理障碍，以及(2)移动 使用以人为本的设计(HCD)和YLWH设计和开发的健康应用程序，以满足 参与护理的障碍。没有被病毒抑制的个体将被随机分配到视频- 咨询应用程序或护理标准(SOC)。通过这项完全远程进行的研究，我们将能够： 目的1：比较视频咨询APP与SOC对青少年儿童医院病毒学的抑制效果。我们会比较一下 HIV病毒学抑制那些在16周时通过随机对照试验随机分为干预组和对照组的患者。 目的2：评估视频咨询APP与SOC对青少年儿童MH和SU的影响。我们将对MH进行评估 16周时干预组与对照组的SU差异通过随机对照试验。 目标3：探索一种ATS以通过分配以下各项来个体化干预： (A)对强化视频咨询应用程序的干预臂中的病毒学“无应答者”又持续16周， (B)干预臂中的病毒学“响应者”，只继续使用应用程序16周。 因此，在MH供应商严重短缺的时代，YLWH的MH和SU挑战至关重要 护理的障碍，检查使用HCD和差异化护理方法开发的创新干预 专门针对YLWH，建立在良好的护理和形成性研究的理论模型基础上， 与社区的伙伴关系对于“零增长”和结束艾滋病毒流行是必要的。

Abstract/Project Summary: In the US, youth and young adults living with HIV (YLWH) have lower rates of antiretroviral therapy (ART) initiation, suboptimal ART adherence and retention in care, and higher rates of virologic failure, compared to older age groups. Additionally, there is an increased risk of substance dependence, psychiatric disorders, and mortality with increased risk of substance use at a younger age. Mental health (MH) and substance use (SU) impact every step of the HIV care continuum from diagnosis to viral suppression and exacerbate socioeconomic challenges of linkage and sustained access to healthcare. Given the strong evidence for the influence of MH and SU on poor HIV health outcomes, there is a clear need for increased access to and provision of these services. Despite the need to address these critical barriers to care in YLWH, there is a severe shortage of MH professionals nationwide and a lack of interventions tailored to this age group. In collaboration with the nonprofit AIDS Healthcare Foundation (the largest provider of HIV care) and a Youth Advisory Panel, the proposed study aims to address these barriers in a tailored manner using a differentiated care approach that is “youth-friendly.” Our goal is to test the effect of a tailored technology-based intervention in a randomized clinical trial (RCT) with an adaptive treatment strategy (ATS) among 200 YLWH (18–29 years old). The intervention includes: (1) brief weekly counseling sessions with a counselor to discuss MH, SU, HIV care engagement, and other barriers to care delivered via a video-chat platform, and (2) a mobile health application designed and developed using Human-Centered Design (HCD) with YLWH to address barriers to engagement in care. Individuals who are not virologically suppressed will be randomized to video- counseling+app or standard of care (SOC). Through this entirely remotely-conducted study, we will be able to: Aim 1: Test the efficacy of video-counseling+app vs SOC on virologic suppression in YLWH. We will compare HIV virologic suppression of those randomized to the intervention vs control arms at 16 weeks via an RCT. Aim 2: Assess the impact of video-counseling+app vs SOC on MH and SU in YLWH. We will evaluate the MH and SU differences between the intervention vs control arms at 16 weeks via an RCT. Aim 3: Explore an ATS to individualize the intervention by assigning the: (a) virologic “non-responders” in the intervention arm to intensified video-counseling+app for 16 more weeks, (b) virologic “responders” in the intervention arm to continue only app use for 16 more weeks. Therefore, in an era of severe shortages of MH providers when MH and SU challenges of YLWH are critical barriers to care, examining an innovative intervention developed using HCD with a differentiated care approach directed specifically to YLWH, grounded in a well-established theoretical model of care and formative research, and with community partnership is necessary for “getting to zero” and ending the HIV epidemic.