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

项目总结/摘要 本研究的目的是引出偏好驱动的策略，以定制适合情境的抗逆转录病毒药物 在南部非洲，为感染艾滋病毒的青年提供一揽子抗逆转录病毒疗法，包括长效注射剂 非洲在南部和东部非洲，青少年和年轻人占所有新感染者的42%， 在南非的这一人群中，病毒抑制的估计范围为10- 50%。莱什提供 YLWH面临的ART坚持和保留挑战的潜在解决方案，但可能不适用于所有青年。 我们假设，如果在偏好的指导下，并与适当的实施策略相结合，LAI可以 改善YLWH的治疗结果。具体目标1：以《综合框架》为指导， 实施研究（CFIR），我们将进行32次采访，年龄在12-29岁之间的YLWH，父母， 儿童和成人艾滋病毒提供者（咨询师，护士，医生），以确定上下文知情的瓶颈， 未来的实施和LAI交付的机会。具体目标2：评价可接受性， 在部分患者偏好中，YLWH 18-29岁人群对LAI的适当性和显示的偏好 试航员YLWH将选择治疗套餐，包括8周（2个月）LAI与2个月 标准口服抗逆转录病毒药物;没有偏好的患者将随机（1：1）接受LAI和药物。主动跟随- 将持续6个月;在每一组中，YLWH将被允许在临床监督下交叉治疗 8-16周之间。主要终点将显示ART偏好（药丸vs. LAI vs.无偏好） 0个月时;以及6个月时药丸与LAI。次要临床终点将包括病毒抑制（<50拷贝 其他次要终点将包括对可接受性、可行性和有效性的评估。 和适当的莱什和邻近的战略，以保持YLWH在照顾。具体目标3：使用偏好 目标2沿着的临床结局数据以及其他临床试验和新出现的观察数据， 在YLWH中的结果情景。这些目标将为全功率R 01实施试验提供信息， 比较病毒载量的信息，定制的LAI交付和支持策略，为YLWH使用顺序 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.