Suubi+Adherence4Youth: Optimizing the Suubi Intervention for Adherence to HIV Treatment for Youth Living with HIV in Uganda

项目摘要 乌干达感染艾滋病毒的青少年人数超过170 000人，而且还在增加。乌干达ALHIV 由于社会和结构性不平等，使他们极易感染艾滋病毒， 最佳的获得和坚持抗逆转录病毒治疗（ART）。在乌干达，不到50%的ALHIV是ART- 粘附，导致病毒抑制率低和艾滋病毒护理的高损耗。为了响应呼吁， 我们寻求扩大针对ALHIV的差异化护理方法和新形式的艾滋病毒综合干预措施， 干预加剧病毒载量不抑制风险的社会和结构性不平等。解决 这些困难可以改善ALHIV的生计，并为他们提供可持续发展的知识和资源 管理艾滋病毒。我们已经在乌干达的四个NIH资助的RCT中证明了Suubi（希望）的有效性。苏比群岛 一个基于证据和理论的组合干预措施，包括四个组成部分：1）金融知识 培训; 2）鼓励将青年储蓄账户与创收活动相匹配; 3） 对坚持抗逆转录病毒治疗和减少耻辱感的干预;以及4）参与艾滋病毒治疗经验的角色 分享艾滋病毒生活经历的模特。Suubi在病毒抑制和ART方面表现出强大的效果 依从性、心理健康和心理社会结果以及家庭财务稳定性。然而，不知道是否每一个 Suubi中的组件是否具有积极的影响，组件如何相互作用，或者更少的组件是否可以 产生了相同的效果。因此，我们提出了一个析因实验来解包和优化Suubi，以提高 利用多阶段优化战略（MOST）扩大卫生系统的规模。我们定义了“优化 目标”作为最具成本效益的干预措施组合，考虑到三个现实世界， 限制：1）效率，2）可负担性，以及3）可扩展性。然后，我们评估干预组件的效果 根据真实世界的信息和成本计算数据调整和平衡这些数据，以根据经验实现优化。 本研究的目的是：目的1。进行析因实验（优化试验），以测试每个因素的主效应 四种Suubi干预成分和成分组合（相互作用）对病毒抑制的影响 （主要结果）;目标2。测试中介者并探索解释和修改关系的调节者 四种Suubi干预成分中的每一种与病毒抑制之间的关系;以及目标3。比较成本和 这四个Suubi干预措施组成部分中的每一个组成部分以及组成部分的每一种组合的成本效益。我们 将使用24因子实验，其中16个条件代表4个组分的所有组合。健康 诊所（N=48）将随机分配至16种条件（每个诊所12例ALHIV），产生主要效应和相互作用 4种组分对持续病毒抑制的作用（定义为在12-，24-， 和36个月的随访评估）。在SSA的现实世界限制内构建的优化干预， 高优先级组是一种创新和有前途的方式，以促进全球艾滋病毒护理的干预科学。

PROJECT ABSTRACT The number of adolescents living with HIV (ALHIV) in Uganda is over 170,000 and growing. Ugandan ALHIV are a priority due to social and structural inequities that make them highly vulnerable to HIV infection and sub- optimal access and adherence to antiretroviral therapy (ART). Less than 50% of ALHIV in Uganda are ART- adherent, leading to low rates of viral suppression and high attrition from HIV care. In response to calls for expanding differentiated care approaches for ALHIV and new forms of combination HIV interventions, we seek to intervene on social and structural inequities that exacerbate the risk for viral load non-suppression. Addressing these hardships can improve ALHIV’s livelihoods and give them the knowledge and resources to sustainably manage HIV. We have shown the effectiveness of Suubi (Hope) in four NIH-funded RCTs in Uganda. Suubi is an evidence-based and theory-informed combination intervention with four components: 1) Financial Literacy Training; 2) Incentivized Matched Youth Savings Accounts with income-generating activities; 3) a manualized intervention for ART adherence and stigma reduction; and 4) Engagement with HIV treatment-experienced role models who share lived experiences of HIV. Suubi has shown robust effects on viral suppression and ART adherence, mental health and psychosocial outcomes, and family financial stability. Yet, it is unknown if each component in Suubi had a positive effect, how the components interacted, or if fewer components could have produced equivalent effects. Hence, we propose a factorial experiment to unpack and optimize Suubi to enhance scale up in health systems using the multi-phase optimization strategy (MOST). We define our “optimization objective” as the most cost-effective combination of intervention components considering three real-world constraints: 1) efficiency, 2) affordability, and 3) scalability. We then evaluate the intervention component effect sizes and balance these data against real-world information and costing data to empirically arrive at optimization. The study aims are: Aim 1. Conduct a factorial experiment (optimization trial) to test the main effects of each of the four Suubi intervention components and combinations of components (interactions) on viral suppression (primary outcome); Aim 2. Test mediators and explore moderators that explain and modify the relationship between each of the four Suubi intervention component and viral suppression; and Aim 3. Compare the cost and cost-effectiveness of each of the four Suubi intervention components and every combination of components. We will use a 24 factorial experiment with 16 conditions representing all combinations of the 4 components. Health clinics (N=48) will be randomized to 16 conditions (12 ALHIV per clinic), yielding main effects and interaction effects for the 4 components on sustained viral suppression (defined as an undetectable viral load at 12-, 24- and 36-month follow-up assessments). An optimized intervention built within real-world constraints in SSA for a high-priority group is an innovative and promising way to advance intervention science for HIV care globally.