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: 10693334
• 负责人: Parya Saberi
• 金额: $ 105.62万
• 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/10693334
• 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; Event; Evidence based intervention; Face; Failure; Foundations; Friends; 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; Provider; Quality of life; Randomized; 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; community partnership; design; disability; efficacy testing; experience; forgetting; health care availability; health disparity; human centered design; human old age (65+); improved; innovation; mortality; primary outcome; randomized, clinical trials; responders and non-responders; skills; 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，艾滋病毒感染者 (YLWH) 的青少年接受抗逆转录病毒治疗 (ART) 的比例较低 与 年龄较大的群体。此外，物质依赖、精神疾病和精神疾病的风险也会增加 死亡率与年轻时物质使用风险增加有关。心理健康 (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 联系和持续获得医疗保健的社会经济挑战。鉴于有强有力的证据 MH 和 SU 对不良艾滋病毒健康结果的影响，显然需要增加获得和 提供这些服务。尽管需要解决 YLWH 护理中的这些关键障碍，但仍有一个问题 全国性的MH专业人员严重短缺，并且缺乏针对该年龄段的干预措施。 与非营利性艾滋病医疗保健基金会（最大的艾滋病毒护理提供者）和 青年咨询小组提出，拟议的研究旨在利用 “青年友好”的差异化护理方法。我们的目标是测试基于技术的定制效果 在一项针对 200 名 YLWH 的随机临床试验 (RCT) 中采用适应性治疗策略 (ATS) 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咨询会议，讨论 MH、SU、艾滋病毒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) 移动设备 使用以人为本的设计 (HCD) 和 YLWH 设计和开发的健康应用程序，以解决 参与护理的障碍。未受到病毒学抑制的个体将被随机分配到视频组 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： 目标 1：测试视频咨询+应用程序与 SOC 对 YLWH 病毒学抑制的功效。我们会比较 通过随机对照试验，在 16 周时对随机分配到干预组和对照组的患者进行 HIV 病毒学抑制。 目标 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 RCT 得出干预组与对照组在 16 周时的 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“无反应者”对强化视频咨询+应用程序再持续 16 周， (b) 干预组中的病毒学“反应者”继续仅使用应用程序 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 护理障碍，检查使用 HCD 和差异化护理方法开发的创新干预措施 专门针对 YLWH，以完善的护理和形成性研究理论模型为基础， 与社区合作对于“实现零排放”和结束艾滋病毒流行至关重要。

项目成果

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.

• DOI: 10.1136/bmjopen-2023-077676
• 发表时间: 2023-10-06
• 期刊: BMJ open
• 影响因子: 2.9