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

青少年艾滋病病毒感染者实现病毒抑制的策略（SAVVY 研究）

基本信息

批准号：
10762109
负责人：
ALLISON L AGWU
金额：
$ 49.88万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-21 至 2028-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10762109
关键词：
12 year old Address Adherence Adolescent and Young Adult Adult Age Baltimore Caring Case Series Characteristics Clinic Clinical Consolidated Framework for Implementation Research Continuity of Patient Care Cost Analysis Counseling Data Decision Making Diagnosis Disease Progression Disparity Dose Economics Elderly Eligibility Determination Enrollment Epidemic Epidemiology Exclusion Friends Goals HIV HIV diagnosis HIV disparities Health Healthcare Systems Immune Individual Injectable Injections Intervention Knowledge Life Oral Outcome Outcome Study Patients Pharmaceutical Preparations Population Provider Public Health Publishing Regimen Reporting Risk Services Structure Surveys System Tablets Time Treatment Protocols Uncertainty United States Viral Viral Load result Viremia Youth adherence rate antiretroviral therapy care delivery cognitive development comorbidity comparison intervention cost cost effective cost effectiveness cost-effectiveness ratio disparity reduction epidemiological model health related quality of life implementation barriers implementation framework improved incremental cost-effectiveness innovation interest mathematical model meetings novel patient-level barriers preference programs provider-level barriers psychosocial scale up social determinants systemic barrier tool transmission process treatment adherence treatment choice treatment strategy uptake young adult

项目摘要

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.

项目摘要青少年和年轻人（AHIV）12-30岁 HIV护理连续体，包括对口腔艺术（OART）和病毒抑制（VS）的依从性较低（VS）老年人，与个人健康和疾病进展不良的个人风险以及公共卫生风险相关次要传输。 AHIV是美国艾滋病毒流行病的优先人群倡议（EHE）。独特的多层因素（例如，认知发展，社会心理决定者，系统障碍）AHIV的不遵守和VS；因此，需要针对AHIV特定的干预措施来解决这些因素并最终改善VS。为了实现这一目标，我们的小组表明，AHIV更有可能是如果在诊所接受青年友好的结构和服务，请保留并实现和维护VS，更有可能使用单片治疗方案（STR）与多台式口服艺术（OART）方案实现VS，并且具有对未口服的艺术策略的浓厚兴趣，特别是长效注射艺术（LAI-ART）。这些发现强调让AHIV参与决策并提供替代生物医学的重要性应该选择的策略，例如Lai-Art，他们应该选择的策略。虽然吸收和推出已经慢速，LAI-ART（Cabotegravir/rilpivirine）管理的Q4-8周已被批准用于艾滋病毒治疗 >已经实现的12岁与12岁的人相比，由于其可能性下降，最多可占所有AHIV的50％。我们已经报告了患者年龄在ART计划中的提供商的偏见和分布，并担心AHIV 可能已经减少了进入LAI-ART的访问权限，从而导致了一个分层系统，该系统排除了LAI-ART的访问谁可能想要和受益最大。 AHIV需要生物医学和护理交付创新来解决他们的通过优化为AHIV提供新颖的生物医学工具的可行性来实现EHE目标的挑战最小化药物和医疗保健系统障碍。实现策略的核心假设艾滋病毒（精明）研究的青年抑制病毒抑制是明智的选择，关于艺术选择的咨询，并支持访问，将提高AHIV中实现和维持的比率。研究提出提出和征求AHIV中有和没有VS的AHIV的明智选择的建议，包括促进Lai-Art（如果可以实现VS）。对于喜欢Lai-Art的AHIV，精明的干预将支持 AHIV在成功开会或维护标准（VL <50副本/毫升）中进行LAI-ART考虑，并部署一支专注的团队，可帮助进入Lai-Art。研究成果包括VS和与健康相关的生活质量（HRQOL）用于接受精明干预的AHIV，使用一个识别实施障碍建立的实施科学框架以及使用一个精明的成本效益的评估经济流行病学模型。我们的跨学科团队具有实施精明研究的专业知识，我们预计精明研究的结果将为现实世界的实施和优化提供信息 Art Ahiv旨在减少结果的差异，并结束AHIV关键人群的流行病。