Strategies to Achieve Viral Suppression for Youth with HIV (The SAVVY Study)

项目摘要 12-30岁的青少年和年轻人（AHIV）在整个国家的结果不成比例地较差。 艾滋病毒护理连续性，包括口服抗逆转录病毒疗法（oART）和病毒抑制（VS）的依从率低于 老年人，与健康状况不佳和疾病进展的个人风险以及 二次传输。艾滋病毒感染者是美国结束艾滋病毒流行的优先人群 倡议（EHE）。独特的多层次因素（例如，认知发展，心理社会决定因素，系统 障碍）是AHIV不依从和VS的基础;因此，需要针对AHIV的干预措施来解决 这些因素，并最终改善VS。朝着这个目标，我们的小组已经表明，AHIV更有可能是 如果在具有青年友好结构和服务的诊所接受护理， 与多片口服ART（oART）方案相比，单片方案（STR）更有可能实现VS， 对非口服抗逆转录病毒疗法的高度兴趣，特别是长效注射抗逆转录病毒疗法（LAI-ART）。这些发现 强调让艾滋病毒/艾滋病参与决策和提供替代生物医学服务的重要性， 他们应该选择的策略，如LAI-ART，以减少日常坚持。虽然采用和推出一直是 缓慢的LAI-ART（cabotegravir/rilpivirine）给药q4-8周已被批准用于治疗那些 >12岁的人已经实现VS-由于VS的可能性降低，排除了高达50%的所有AHIV。 我们已经报道了提供者的偏见和差异，在ART启动患者的年龄，并担心AHIV 可能减少了LAI-ART的使用，导致分层系统排除了LAI-ART的使用， 最想要并从中获益的人艾滋病毒需要生物医学和护理提供创新，以解决其 通过优化为AHIV提供新型生物医学工具的可行性来实现EHE目标的挑战， 最大限度地减少医疗和保健系统的障碍。实现战略的核心假设 艾滋病毒感染青年的病毒抑制研究是知情选择，对ART选择的咨询， 并促进获得，将增加艾滋病毒感染者实现和维持VS的比率。研究 建议在有和没有VS的AHIV患者中提出并征求知情的ART选择，包括 促进LAI-ART（如果能够实现VS）。对于喜欢LAI-ART的AHIV患者，SAVVY干预将支持 AHIV成功满足或维持LAI-ART考虑的标准（VL<50拷贝/mL），并部署 一个专注的团队，促进获得LAI-ART。研究结果包括VS和健康相关的生活质量 （HRQOL）对于接受SAVVY干预的AHIV，利用 建立了执行科学框架，并使用一个 经济流行病学模型我们的跨学科团队拥有实施SAVVY研究的专业知识， 预计SAVVY研究的结果将为LAI的实际实施和优化提供信息- 抗逆转录病毒疗法旨在减少结果的差异，并结束艾滋病毒主要人群的流行。

PROJECT SUMMARY Adolescents and young adults (AHIV) ages 12-30 years have disproportionately poorer outcomes across the HIV care continuum, including lower rates of adherence to oral ART (oART) and viral suppression (VS) than older adults, correlating with individual risk of poor health and disease progression and public health risk of secondary transmission. AHIV are a priority population in the Ending the HIV Epidemic in the United States Initiative (EHE). Unique multi-layered factors (e.g., cognitive development, psychosocial determinants, system barriers) underlie AHIV's nonadherence and VS; therefore, AHIV-specific interventions are needed to address those factors and ultimately improve VS. Toward this aim, our group has shown that AHIV are more likely to be retained in care and achieve and maintain VS if cared for at clinics with youth-friendly structures and services, more likely to achieve VS with single tablet regimens (STR) vs. multi-tablet oral ART (oART) regimens, and have high interest in ART strategies not taken orally, specifically long-acting injectable ART (LAI-ART). These findings underscore the importance of engaging AHIV in decision-making and providing access to alternative biomedical strategies that obviate daily adherence, like LAI-ART, should they choose. Though uptake and rollout has been slow, LAI-ART (cabotegravir/rilpivirine) administered q4-8 weeks has been approved for HIV treatment in those >12 years-old who have achieved VS—excluding up to 50% of all AHIV due to their decreased likelihood of VS. We have reported provider biases and disparities in ART initiation by patient age and have concern that AHIV may have decreased access to LAI-ART, resulting in a tiered system that precludes LAI-ART access from those who may want and benefit from it most. AHIV need biomedical and care delivery innovations to address their challenges meeting EHE goals by optimizing feasibility of delivering novel biomedical tools for AHIV through minimizing medication and healthcare system barriers. The central hypothesis of the Strategies to AchieVe Viral Suppression for Youth with HIV (SAVVY) Study is that informed choice, counseling on ART options, and facilitating access, will increase rates of achieving and sustaining VS among AHIV. The study proposes to present and solicit informed choice of ART among both AHIV with and without VS, including facilitating LAI-ART (if VS can be achieved). For AHIV who prefer LAI-ART, the SAVVY intervention will support AHIV in successfully meeting or maintaining criteria (VL<50 copies/mL) for LAI-ART consideration, and deploy a focused team that facilitates access to LAI-ART. Study outcomes include VS and health-related quality of life (HRQOL) for AHIV undergoing the SAVVY intervention, identification of implementation barriers utilizing an established implementation science framework, and assessment of the cost-effectiveness of SAVVY using an economic-epidemiologic model. Our interdisciplinary team has expertise to implement the SAVVY study and we anticipate that the results of The SAVVY study will inform the real-world implementation and optimization of LAI- ART AHIV toward reducing disparities in outcomes and ending the epidemic for the key population of AHIV.