Designing Next Generation Treatment Strategies for Adolescents and Young Adults Living with HIV (The NextGen Study)

项目摘要/摘要 这项研究的目标是引出偏好驱动的策略，以量身定做适合背景的抗逆转录病毒药物 治疗(ART)包，包括长效注射剂(LAI)，用于南方艾滋病毒携带者(YLWH) 非洲。青少年和青壮年占南部和东部非洲所有新感染病例的42%， 在南非的这些人群中，病毒抑制的估计范围从10%到50%。LAI提供了一个 YLWH面临的抗逆转录病毒药物坚持和保留挑战的潜在解决方案，但可能不适用于所有年轻人。 我们假设，如果在偏好的指导下，并配合适当的实施策略，LAI可以 改善青梅竹马医院的治疗结果。具体目标1：以综合框架为指导 实施研究(CFIR)，我们将对12-29岁的YLWH、父母和 儿科和成人艾滋病毒提供者(顾问、护士、医生)，以确定背景信息瓶颈 未来的实施和LAI交付的机会。具体目标2：评估可接受性， 部分患者偏好中18-29岁青少年儿童对LAI的适宜性和显性偏好 试飞员。YLWH将在包括8周(2个月)LAI和2个月的治疗方案之间进行选择 标准口腔艺术药丸；那些没有偏爱的人将被随机(1：1)接受LAI与药丸。积极关注- UP将持续6个月；在每个手臂上，青年会将被允许在临床监督下交叉手臂 在8-16周之间。主要终点将显示艺术偏好(药丸与LAI对比无偏好) 在0个月时；在6个月时，药片与LAI。次要临床终点将包括病毒抑制(&lt；50份 每毫升)和对ART的保留；其他次要终点将包括可接受性、可行性的评估 以及LAI和邻近战略的适当性，以保持青瓦台在护理中的地位。具体目标3：使用偏好 和来自Aim 2的临床结果数据以及其他临床试验和新出现的观察数据一起建模 YLWH之间的结果情景。这些目标将为全功率R01实施试验提供参考， 使用序贯试验比较青海医院的病毒负载知晓、量身定做的LAI交付和支持策略 多分配随机试验(SMART)设计。

Project Summary/Abstract The goal of this study is to elicit preference-driven strategies to tailor contextually appropriate antiretroviral therapy (ART) packages, including long-acting injectables (LAI), for youth living with HIV (YLWH) in South Africa. Adolescents and young adults comprise 42% of all new infections in southern and eastern Africa, and among this population in South Africa, estimated ranges of viral suppression are from 10-50%. LAIs offer a potential solution for ART adherence and retention challenges faced by YLWH but may not work for all youth. We hypothesize that if guided by preferences and paired with appropriate implementation strategies, LAI can improve treatment outcomes among YLWH. Specific Aim 1: Guided by the Consolidated Framework for Implementation Research (CFIR), we will conduct 32 interviews with YLWH aged 12-29 years, parents, and pediatric and adult HIV providers (counselors, nurses, doctors) to identify context-informed bottlenecks to future implementation and opportunities for LAI delivery. Specific Aim 2: Evaluate acceptability, appropriateness and revealed preferences for LAI among YLWH 18-29 years in a partial patient preference trial pilot. YLWH will choose between treatment packages that include 8-weekly (2-monthly) LAI vs 2-monthly standard oral ART pills; those with no preference will be randomized (1:1) to receive LAI vs. pills. Active follow- up will continue for 6-months; in each arm, YLWH will be allowed to cross-over arms with clinical supervision between 8-16 weeks. The primary endpoints will be revealed ART preference (pills vs. LAI vs. no preference) at 0-months; and pill vs. LAI at 6-mos. Secondary clinical endpoints will include viral suppression (<50 copies per ml) and retention on ART; other secondary endpoints will include assessments of acceptability, feasibility and appropriateness of LAIs and adjacent strategies to retain YLWH in care. Specific Aim 3: Use preference and clinical outcomes data from Aim 2 along with other clinical trial and emerging observational data to model outcomes scenarios amongst YLWH. These aims will inform a fully powered R01 implementation trial, comparing viral load-informed, tailored LAI delivery and support strategies for YLWH using a sequential multiple assignment randomized trial (SMART) design.