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

 描述(申请人提供)：在美国，超过一半的艾滋病毒/艾滋病患者(PLHA)没有充分参与艾滋病毒初级保健，也没有接受抗逆转录病毒治疗(ART)，主要是非洲裔美国人和拉美裔美国人。在拟议的项目中，两名经验丰富且多产的行为科学家将采用一种强有力的创新研究方法--多阶段优化战略(MOST)，以开发一种高效、高效、可扩展和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。尽管随机对照试验(RCT)对于综合评价多组分干预措施的有效性很有价值，但它们并不是用来评价哪些特定组分对疗效有贡献的。MOST是一个开创性的、受工程启发的框架，通过高效的随机实验来评估单个干预组件及其相互作用的性能，从而解决这个问题。我们建议使用MOST来设计一项干预措施，以增加对非裔美国人和拉丁裔PLHA没有很好地从事护理和不接受ART的艾滋病毒护理连续体的参与度。此外，干预措施将针对成本效益进行优化。在资源有限的情况下，这种效率和成本效益至关重要，也将增加干预措施未来的可扩展性。NIH已经表示对MOST感兴趣，这是第一次将其应用于成人HIV治疗领域的研究。一组类似的多层面因素阻碍了非裔美国人和拉丁裔PLHA的艾滋病毒护理和抗逆转录病毒治疗的启动，其中主要是个人因素(例如药物使用、不信任、恐惧)、社会因素(例如耻辱)和结构层面的障碍(例如获得辅助服务的困难)。在多层次社会认知理论的指导下，这项研究将评估5个不同的干预组成部分(即动机访谈会议、遵守前准备、支持小组、同伴指导和患者导航)，每个组成部分都旨在解决艾滋病毒护理和ART启动的特定障碍。这些成分在经验性文献中有很好的基础，在初步研究中被发现是可接受的、可行的和有希望的疗效。研究的目标是：1)使用高效的实验设计，确定5种成分中哪些对改善病毒抑制有意义，以及抗逆转录病毒疗法的坚持和参与艾滋病毒初级保健的次要结果；2)确定成分疗效的中介和调节因素；3)使用数学建模方法，从有效成分中构建最具成本效益和效率的干预方案。非裔和拉丁裔PLHA的不同样本(关于年龄、药物使用和性少数地位)将通过在社区环境中使用定向抽样和同伴招募(N=512)的经过验证的混合抽样方法进行招募。这项极具创新性和重大意义的研究涉及一个高度优先的研究领域(NIH NOT-OD-15-137)，将为全国最脆弱的PLHA产生艾滋病毒护理连续干预措施，优化成本效益，并具有非凡的效力、效率和可扩展性。

 DESCRIPTION (provided by applicant): 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 ield 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 accesing 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.