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

项目摘要 乌干达的青少年艾滋病毒携带者人数超过17万人，而且还在增加。乌干达ALHIV 是一个优先事项，因为社会和结构性不平等使他们非常容易受到艾滋病毒感染和亚 最佳获得和坚持抗逆转录病毒治疗(ART)。在乌干达，只有不到50%的ALHIV是抗逆转录病毒药物- 粘附性，导致低病毒抑制率和艾滋病毒护理的高自然流失率。为响应要求 扩大ALHIV的差异化护理方法和新形式的组合艾滋病毒干预措施，我们寻求 对加剧病毒载量不受抑制风险的社会和结构性不平等进行干预。寻址 这些困难可以改善艾滋病病毒感染者的生计，并为他们提供可持续发展的知识和资源 管理艾滋病毒。我们已经在乌干达由美国国立卫生研究院资助的四项随机对照试验中展示了Suubi(希望)的有效性。Suubi是 循证与理论相结合的干预方法，包括四个组成部分：1)金融知识 培训；2)通过创收活动激励匹配的青年储蓄账户；3)手册 干预：坚持抗逆转录病毒疗法和减少耻辱；以及4)参与艾滋病毒治疗--有经验的角色 分享艾滋病毒亲身经历的模特。Suubi在病毒抑制和ART方面显示出强大的效果 坚持性、心理健康和心理社会结果，以及家庭经济稳定。然而，目前还不清楚是否每个人 Suubi中的组件有积极的影响，组件如何交互，或者更少的组件是否可以 产生了同等的效果。因此，我们提出了一个析因实验来拆解和优化Suubi，以增强 使用多阶段优化战略(MOST)扩大卫生系统的规模。我们定义了我们的“优化” 目标“作为最具成本效益的干预组件组合，考虑到了三个现实世界 限制：1)效率，2)可负担性，3)可伸缩性。然后，我们评估干预组件的效果 调整这些数据的大小，并根据实际信息和成本计算数据进行权衡，以达到经验上的最优化。 本研究的目的是：目的1.进行析因实验(优化试验)，以检验每一个因素的主效应 抑制病毒的四种苏必干预成分及其组合(相互作用) (主要结果)；目标2.测试调解人并探索解释和修改关系的调解人 四种Suubi干预成分和病毒抑制之间的关系；以及目标3。比较成本和 四个Suubi干预组件和每个组件组合的成本效益。我们 将使用代表4种成分的所有组合的16个条件的24次析因实验。健康状况 诊所(N=48)将被随机分成16种情况(每个诊所12种ALHIV)，产生主要影响和相互作用 这4个组分对持续病毒抑制的影响(定义为12-，24- 和36个月的跟踪评估)。在SSA中的现实世界约束下构建的优化干预 高优先级小组是一种创新和有前途的方式，可以在全球范围内推动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.