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: 9925349
• 负责人: LINDA M COLLINS
• 金额: $ 8.55万
• 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/9925349
• 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; Health Care Costs; Hybrids; Individual; Intervention; Intervention Studies; Latino; 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; Research; Research Methodology; Research Priority; Resources; Risk Factors; Sampling; Science; Scientist; Self Determination; Services; Signal Transduction; Structure; Support Groups; Testing; Time; Treatment Efficacy; Triad Acrylic Resin; United States National Institutes of Health; Viral; Viral Load result; Vulnerable Populations; antiretroviral therapy; behavior change; college; community setting; cost effective; cost effectiveness; design; effective intervention; 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; racial and ethnic; racial and ethnic disparities; recruit; secondary outcome; sexual minority; social; social cognitive theory; social stigma; theories; therapy adherence; transmission process; treatment services

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.

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教育。 护理和不采取抗逆转录病毒疗法（ART），主要是非洲裔美国人和拉丁美洲人。拟议 项目，两个经验丰富，富有成效的行为科学家将采用一个强大的和创新的研究 方法，多阶段优化战略（MOST），开发一个高效，高效， 可扩展的、具有成本效益的干预措施，以增加沿着艾滋病毒护理连续体的参与。而 随机对照试验（RCTs）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，它们的设计目的不是评估哪些特定成分有助于功效。至多 开创性的，工程启发的框架，解决了这个问题，通过高效的随机 实验，以评估个别干预措施及其相互作用的表现。我们 建议利用社会变革管理计划设计一项干预措施，以增加沿着艾滋病毒护理连续体的参与， 非裔美国人和拉丁裔PLHA没有很好地参与护理，没有接受ART。 优化成本效益。这种效率和成本效益是至关重要的，在一个时间的限制， 资源，并将增加干预措施的未来可扩展性。NIH已经表示对MOST感兴趣， 这是第一个将其应用于成人艾滋病治疗领域的研究。一系列类似的多层次因素阻碍了 为非洲裔美国人和拉丁裔PLHA提供艾滋病毒护理和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，本研究将评估5种不同的干预措施， 组件（即，激励性面试课程、遵守前准备、支持小组、同侪 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。 这些组成部分在经验文献中有很好的基础，被认为是可接受的、可行的， 在初步研究中有希望获得疗效。研究目的是：1）采用高效的 实验设计，确定5种组分中的哪一种对改善病毒 抑制，以及辅助治疗依从性和参与艾滋病毒初级保健的次要结果; 2）确定 调解人和调解人的组成部分的功效;和3）使用数学建模方法，建立 最具成本效益和有效的干预措施。异构 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） 将采用经过验证的混合抽样方法，在社区环境和同行中进行有针对性的抽样， 招募（N = 512）。这项高度创新和重要的研究，它解决了一个高优先级的研究 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，并具有出色的功效、效率和可扩展性。