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.

项目概要 12-30 岁的青少年和年轻人 (AHIV) 的预后较差 HIV 护理连续性，包括口服 ART (oART) 和病毒抑制 (VS) 的坚持率低于老年人，与个人健康状况不佳和疾病进展的风险以及公共卫生风险相关 AHIV 是终结美国艾滋病流行的重点人群。主动性（EHE）。独特的多层因素（例如认知发展、社会心理决定因素、系统）障碍）是 AHIV 不依从和 VS 的根源，因此需要针对 AHIV 的干预措施来解决为了实现这一目标，我们的团队已经证明 AHIV 更有可能被感染。如果在具有青年友好结构和服务的诊所接受护理，则可以保留护理并实现和维持 VS，与多片口服 ART (oART) 方案相比，采用单片方案 (STR) 更有可能实现 VS，并且对非口服抗逆转录病毒疗法（ART）策略高度感兴趣，特别是长效注射抗逆转录病毒疗法（LAI-ART）。强调让 AHIV 参与决策并提供替代生物医学的重要性避免日常坚持的策略，如 LAI-ART，如果他们选择的话，尽管已经被采用和推广。慢速、LAI-ART（卡博替拉韦/利匹韦林）每 4-8 周给药一次已被批准用于 HIV 治疗已实现 VS 的 12 岁以上儿童 — 排除高达 50% 的 AHIV，因为他们发生 VS 的可能性降低。我们报告了按患者年龄划分的提供者在开始 ART 方面的偏见和差异，并担心 AHIV 可能会减少对 LAI-ART 的访问，从而导致分层系统阻止这些人访问 LAI-ART AHIV 患者最需要生物医学和护理服务创新来解决他们的问题。通过优化为 AHIV 提供新型生物医学工具的可行性来实现 EHE 目标的挑战药物和医疗保健系统障碍的实现策略的中心假设。青少年艾滋病病毒感染者病毒抑制 (SAVVY) 研究是关于 ART 选择的知情选择、咨询、并促进获得，将提高 AHIV 人群实现和维持 VS 的比率。建议在有或没有 VS 的 AHIV 患者中提出并征求 ART 的知情选择，包括促进 LAI-ART（如果可以实现 VS），对于喜欢 LAI-ART 的 AHIV，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 研究成果，包括 VS 和健康相关的生活质量。 (HRQOL) 对于接受 SAVVY 干预的 AHIV，识别实施障碍并利用建立了实施科学框架，并使用 SAVVY 的成本效益评估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 ART AHIV 旨在减少结果差异并结束 AHIV 重点人群的流行。