Using MOST to optimize an HIV care continuum intervention for vulnerable populations

在美国，超过一半的艾滋病毒/艾滋病携带者(PLHA)没有充分参与艾滋病毒的初级治疗 护理和不接受抗逆转录病毒治疗(ART)，主要是非裔美国人和拉丁裔。在建议的 项目中，两名经验丰富且多产的行为科学家将利用一项强有力的创新研究 方法论，多阶段优化策略(MOST)，以开发高效、高效、 可扩展的、具有成本效益的干预措施，以增加艾滋病毒护理连续体系的参与度。鉴于 随机对照试验(RCT)对于评价多组分干预措施的有效性是有价值的 作为一个整体，它们并不是为了评估哪些特定成分对疗效有贡献而设计的。大多数，a 开创性的、受工程启发的框架，通过高效的随机化解决了这个问题 评估单个干预组件及其相互作用的性能的实验。我们 建议使用MOST来设计干预措施，以增加艾滋病毒护理连续体系的参与度 非裔和拉丁裔PLHA没有很好地从事护理和学习艺术。此外，干预将 针对成本效益进行优化。这种效率和成本效益在一个受限制的时代是至关重要的 资源，还将增加干预措施未来的可扩展性。NIH已经表示对MOST感兴趣， 这是将其应用于成人艾滋病毒治疗领域的第一项研究。一组相似的多层次因素阻碍了 非裔美国人和拉丁裔PLHA的艾滋病毒护理和ART启动，其中主要是个人(例如， 物质使用、不信任、恐惧)、社会(例如，污名)和结构性障碍(例如，难以获得 辅助服务)。在多层次社会认知理论的指导下，该研究将评估5种不同的干预措施 组成部分(即激励性面谈会议、遵守前准备、支持小组、同伴 指导和患者导航)，每个都旨在解决艾滋病毒护理和抗逆转录病毒治疗启动的特定障碍。 这些组件在经验文献中有很好的基础，并且被发现是可接受的、可行的和 在初步研究中，在疗效方面很有希望。研究目标是：1)使用高效的 实验设计，确定5种成分中哪些对改善病毒有意义 在艾滋病毒初级保健中坚持和参与抗逆转录病毒疗法的抑制和次要结果；2)确定 3)使用数学建模方法，构建组件效能的 最具性价比和效率的干预套餐由有效成分组成。一种异类 非裔美国人和拉丁裔PLHA样本(关于年龄、药物使用和性少数地位) 将在社区环境和同龄人中使用经过验证的混合抽样方法进行招募 招聘(N=512人)。这项极具创新性和重大意义的研究解决了一项高度优先的研究 地区(NIH NOT-OD-15-137)，将为全国最脆弱的人群提供艾滋病毒护理连续干预 PLHA，针对成本效益进行了优化，具有卓越的功效、效率和可扩展性。

More than half of persons living with HIV/AIDS (PLHA) in the U.S. are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans and Latinos. In the proposed project, two experienced and productive behavioral scientists will employ a potent and innovative research methodology, the Multiphase Optimization STrategy (MOST), to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials (RCTs) are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American and Latino PLHA not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. This efficiency and cost-effectiveness are critical in a time of constrained resources, and will also increase the intervention's future scalability. NIH has signaled its interest in MOST, and this is the first study to apply it in the field of adult HIV treatment. A similar set of multi-level factors impede both HIV care and ART initiation for African American and Latino PLHA, primary among them individual (e.g., substance use, distrust, fear), social (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, the study will evaluate 5 distinct intervention components (i.e., Motivational Interviewing sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. Study aims are: 1) using a highly efficient experimental design, identify which of 5 components contribute meaningfully to improvement in viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American and Latino PLHA (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N=512). This highly innovative and significant study, which addresses a high-priority research area (NIH NOT-OD-15-137), will produce an HIV care continuum intervention for the nation's most vulnerable PLHA, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.