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

使用 MOST 优化针对弱势群体的 HIV 护理连续干预

• 批准号: 9137118
• 负责人: LINDA M COLLINS
• 金额: $ 116.15万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9137118
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Adult; African American; Age; Alcohol or Other Drugs use; Area; Behavioral; Biological Markers; Caring; Clinic; Continuity of Patient Care; Discipline of Nursing; Engineering; Enrollment; Experimental Designs; Fright; Funding; Future; HIV; Hair; Healthcare; Hybrids; Individual; Intervention; Intervention Studies; Latino; Life; Literature; Mediator of activation protein; Medical Records; Mental Health; Mentorship; Methods; Morbidity - disease rate; NIH Office of AIDS Research; Participant; Patients; Performance; Persons; Population; Preparation; Prevention; Primary Health Care; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Research; Research Methodology; Research Priority; Resources; Risk Factors; Sampling; Science; Scientist; Self Determination; Services; Signal Transduction; Support Groups; Testing; Time; Treatment Efficacy; United States National Institutes of Health; Viral; Viral Load result; Vulnerable Populations; antiretroviral therapy; behavior change; college; community setting; cost effective; cost effectiveness; design; ethnic health disparity; experience; innovation; interest; intrinsic motivation; mathematical model; men who have sex with men; mortality; motivational enhancement therapy; multi-component intervention; peer; primary outcome; public health relevance; racial and ethnic; racial and ethnic disparities; secondary outcome; sexual minority; social; social cognitive theory; social stigma; theories; therapy adherence; transmission process

 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.

 描述（由申请人提供）：在美国，超过一半的艾滋病毒/艾滋病（PLHA）感染者没有充分参与艾滋病毒的初级保健，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丁美洲人。在拟议的项目中，两位经验丰富、富有成效的行为科学家将采用一种有效的创新研究方法--多阶段优化战略（MOST），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沿着参与度。尽管随机对照试验（RCT）对于评价多组分干预措施作为一个整体的疗效很有价值，但它们并不是为了评价哪些特定组分有助于疗效。MOST是一个开创性的、受工程启发的框架，它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，从而解决了这一问题。我们建议利用社会变革管理计划来设计一项干预措施，以增加参与沿着艾滋病毒护理连续体的非洲裔美国人和拉丁美洲PLHA没有很好地参与护理和不采取抗逆转录病毒治疗。在资源有限的时期，这种效率和成本效益至关重要，而且还将提高干预措施的未来可扩展性。美国国立卫生研究院已经表示对MOST的兴趣，这是第一个将其应用于成人艾滋病治疗领域的研究。一组类似的多层次因素阻碍了非洲裔美国人和拉丁美洲人PLHA的艾滋病毒护理和ART启动，其中主要是个人因素（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，获得辅助服务的困难）。在多层次社会认知理论的指导下，该研究将评估5个不同的干预成分（即，动机访谈会议，坚持前准备，支持小组，同伴指导和患者导航），每一个都旨在解决艾滋病毒护理和ART启动的特定障碍。这些成分在经验文献中有充分的依据，并且在初步研究中发现其有效性可接受、可行且有前景。研究目的是：1）使用高效的实验设计，确定5个组件中的哪些组件对病毒抑制的改善有意义，以及ART依从性和参与艾滋病毒初级保健的次要结果; 2）确定组件功效的中介者和调节者; 3）使用数学建模方法，从有效组件中构建最具成本效益和最有效的干预方案。将采用经过验证的混合抽样方法，在社区环境中使用有针对性的抽样和同伴招募（N=512），招募非裔美国人和拉丁裔PLHA的异质样本（关于年龄、药物使用和性少数群体状态）。这项高度创新和重要的研究，解决了一个高优先级的研究领域（NIH NOT-OD-15-137），将为全国最脆弱的PLHA提供艾滋病毒护理连续干预，优化成本效益，并具有卓越的功效，效率和可扩展性。