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

全面、量身定制、基于技术的干预措施，以改善艾滋病毒感染者的病毒抑制

• 批准号: 10546315
• 负责人: Parya Saberi
• 金额: $ 95.13万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10546315
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adult; Age; Algorithms; Behavioral; Caring; Characteristics; Clinical; Collaborations; Communities; Continuity of Patient Care; Counseling; Data; Diagnosis; Economics; Epidemic; Evidence based intervention; Face; Failure; Foundations; Geography; Goals; HIV; Health; Health Personnel; Health Professional; Healthcare; Home; Human Resources; Individual; Intervention; Life Expectancy; Logistics; Medication Management; Mental Health; Mental disorders; Methods; Mobile Health Application; Modeling; Morbidity - disease rate; Motivation; Outcome; Participant; Professional counselor; Protocols documentation; Provider; Randomized; Randomized Clinical Trials; Research; Resources; Risk; Service provision; Services; Social Workers; Social isolation; Substance Addiction; Technology; Testing; Theoretical model; Time; Training; Treatment Efficacy; Viral; Youth; age group; antiretroviral therapy; arm; barrier to care; base; community partnership; design; disability; efficacy testing; experience; forgetting; health care availability; health disparity; human centered design; improved; innovation; mortality; primary outcome; responders and non-responders; skills; social; social stigma; socioeconomics; standard of care; substance use; substance use treatment; therapy adherence; transmission process; treatment arm; treatment services; treatment strategy; video chat; video coaching; young adult

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.

摘要/项目摘要： 在美国，年轻人和年轻成人艾滋病毒感染者（YLWH）接受抗逆转录病毒治疗（ART）的比例较低 启动，次优的ART依从性和护理保留，以及更高的病毒学失败率，与 老年群体。此外，物质依赖、精神障碍和 在较年轻的年龄使用药物的风险增加的死亡率。精神健康（MH）和物质使用（SU） 影响从诊断到病毒抑制的艾滋病毒护理连续体的每一步， 联系和可持续获得保健的社会经济挑战。鉴于强有力的证据表明， 由于MH和SU对艾滋病毒健康结果不佳的影响，显然需要增加获得 提供这些服务。尽管需要解决这些关键的障碍，以照顾在YLWH，有一个 全国严重缺乏卫生保健专业人员，缺乏针对这一年龄组的干预措施。 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，拟议的研究旨在以一种有针对性的方式， 差异化护理方法，即“青年友好型”。我们的目标是测试量身定制的基于技术的 在200名YLWH中采用适应性治疗策略（ATS）的随机临床试验（RCT）中进行干预 （18-29岁）。干预措施包括：（1）每周与辅导员进行简短的辅导， MH、SU、HIV护理参与以及通过视频聊天平台提供护理的其他障碍，以及（2）移动的 使用以人为本的设计（HCD）和YLWH设计和开发的健康应用程序， 参与护理的障碍。未被病毒学抑制的个体将被随机分配至视频- 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：测试视频咨询+应用程序与SOC在YLWH病毒学抑制中的有效性。我们将比较 通过随机对照试验，随机分配至干预组与对照组的患者在16周时的HIV病毒学抑制。 目的2：评估视频咨询+应用程序与SOC对YLWH中MH和SU的影响。我们将评估MH 通过随机对照试验，观察16周时干预组与对照组之间的SU差异。 目标3：探索ATS，通过分配以下内容来个性化干预： (a)干预组中的病毒学“无应答者”接受强化视频咨询+应用程序治疗16周以上， (b)干预组中的病毒学“应答者”继续只使用应用程序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与差异化护理方法开发的创新干预措施 专门针对YLWH，扎根于护理和形成性研究的成熟理论模型， 并与社区伙伴关系是必要的“达到零”和结束艾滋病毒流行病。