Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

在进入 iENGAGE 时整合参与和遵守目标以控制 HIV

• 批准号: 8663187
• 负责人: MICHAEL J MUGAVERO
• 金额: $ 74.72万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-21 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8663187
• 关键词: AIDS prevention; Address; Adherence; Area Under Curve; Behavior; Behavioral; Biostatistics Core; Caring; Centers for Disease Control and Prevention (U.S.); Climacteric; Clinic; Clinic Visits; Clinical; Collaborations; Communities; Complex; Counseling; Data; Development; Diagnosis; Disclosure; Education; Epidemiology; Event; Evidence based intervention; Face; Failure; Fostering; Foundations; Goals; Growth; HIV; HIV Infections; HIV diagnosis; Health; Health Benefit; Health Care Visit; Human immunodeficiency virus test; Individual; Intervention; Intervention Studies; Life; Life Experience; Link; Measurement; Mediator of activation protein; Medical; Modeling; Monitor; Motivation; Outcome; Outcome Measure; Outpatients; Patients; Persons; Pharmaceutical Preparations; Plasma; Play; Prevention; Professional counselor; Qualifying; Relative (related person); Research Infrastructure; Research Personnel; Resources; Role; Science; Self Care; Structural Models; Subgroup; System; Testing; Time; Training; United States National Institutes of Health; Viral Load result; Viremia; Visit; Work; antiretroviral therapy; base; clinical care; cohort; data management; empowered; evidence base; experience; innovation; instrument; meetings; novel; population health; skills; standard of care; theories; therapy adherence

DESCRIPTION (provided by applicant): The first year of outpatient HIV medical care is a dynamic, formative and vulnerable time. While adjusting to a life changing diagnosis, patients must simultaneously develop HIV visit adherence and antiretroviral therapy (ART) adherence behavioral skills to achieve plasma viral load (VL) suppression. Moreover, maintaining "HIV adherence" in a broader context is essential to sustaining VL suppression over time, with vital consequences to individual health and profound implications for secondary HIV prevention. It is alarming that no existing evidence-based intervention supports the simultaneous development of patient information, motivation and behavioral skills for both HIV medical visit and ART adherence at this critical time. Accordingly, we will draw content from our existing, pilot-tested interventions that target these separate adherence behaviors to evaluate an integrated intervention approach tailored to the needs of an individual initiating outpatient HIV medical care. The proposed iENGAGE intervention (integrating ENGagement and Adherence Goals upon Entry) has two overarching goals: (1) to facilitate patient adjustment to a new diagnosis of HIV infection, and, (2) to develop the necessary patient information, motivation and skills for optimal HIV visit and ART adherence. The following specific aims are driven by a unified conceptual model, linked with explicit measurement instruments, and a detailed analysis plan. Aim 1: Integrate content from our pilot-tested and evidence-based CDC Retention in Care and PACT ART adherence interventions for the comprehensive iENGAGE intervention to promote VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care. Aim 2: Evaluate the efficacy of the iENGAGE intervention vs. standard of care in achieving 48-week VL suppression (<50 c/mL) among patients newly initiating outpatient HIV medical care. Aim 3: Evaluate (a) modifiers and (b) mediators of iENGAGE efficacy, using (a) subgroup analysis to estimate important subgroup effects and (b) marginal structural models to estimate the role of intervention components in the overall effect. Identify (c) baseline and longitudinal predictors of VL outcomes using marginal structural models among patients receiving standard of care. Our investigative team has a strong track record of collaboration and the collective expertise in HIV behavioral, clinical, and epidemiological sciences to successfully complete this innovative scope of work. Considerable emphasis and resources have appropriately focused on expanding HIV testing, and interventions have proven efficacious in linking patients from the community to an HIV clinic. In contrast, a paucity of intervention research has focused on patients newly initiatin outpatient HIV medical care. The iENGAGE intervention aims to convert this vulnerable time to a teachable moment during which patients develop information, motivation and adherence skills to achieve and sustain VL suppression. Study findings will play a pivotal role in addressing the scientific void around this dynamic period - a critical time if we are to maximally realize the individual and population health benefits (i.e., treatment as prevention) of VL suppression.

描述（由申请人提供）：艾滋病毒门诊医疗护理的第一年是一个充满活力、形成和脆弱的时期。在适应改变生活的诊断的同时，患者必须同时培养艾滋病毒就诊依从性和抗逆转录病毒治疗 (ART) 依从性行为技能，以实现血浆病毒载量 (VL) 抑制。此外，在更广泛的背景下保持“艾滋病毒依从性”对于长期维持VL抑制至关重要，这对个人健康产生重大影响，并对艾滋病毒二级预防产生深远影响。令人震惊的是，现有的循证干预措施不支持在这一关键时刻同时发展患者信息、动机和行为技能，以进行艾滋病毒就诊和抗逆转录病毒疗法的依从性。因此，我们将从针对这些单独的依从行为的现有试点测试干预措施中汲取内容，以评估适合开始门诊艾滋病毒医疗护理的个人需求的综合干预方法。拟议的 iENGAGE 干预措施（整合参与和入院时的依从性目标）有两个总体目标：(1) 促进患者适应 HIV 感染的新诊断，以及 (2) 开发必要的患者信息、动机和技能，以实现最佳的 HIV 就诊和 ART 依从性。以下具体目标由统一的概念模型驱动，与明确的测量工具和详细的分析计划相联系。目标 1：整合我们经过试点测试和循证的 CDC 护理保留和 PACT ART 依从性干预措施的内容，进行全面的 iENGAGE 干预，以促进新开始门诊 HIV 医疗护理的患者的 VL 抑制（<50 c/mL）。目标 2：评估 iENGAGE 干预与标准护理在新开始门诊 HIV 医疗护理的患者中实现 48 周 VL 抑制 (<50 c/mL) 的效果。目标 3：评估 iENGAGE 功效的 (a) 调节因素和 (b) 调节因素，使用 (a) 亚组分析来估计重要的亚组效应，并使用 (b) 边际结构模型来估计干预成分在总体效果中的作用。确定 (c) 基线和纵向预测因素 在接受标准护理的患者中使用边缘结构模型的 VL 结果。我们的调查团队在艾滋病毒行为、临床和流行病学科学方面拥有良好的合作记录和集体专业知识，能够成功完成这一创新工作范围。相当多的重点和资源适当地集中在扩大艾滋病毒检测上，事实证明，干预措施在将社区患者与艾滋病毒诊所联系起来方面是有效的。相比之下，很少有干预研究关注新开始门诊艾滋病毒医疗护理的患者。 iENGAGE 干预旨在将这段脆弱的时间转变为一个受教育的时刻，在此期间患者发展信息、动机和坚持技能，以实现和维持 VL 抑制。研究结果将在解决这一动态时期的科学空白方面发挥关键作用——如果我们要最大限度地实现 VL 抑制对个人和人群健康的益处（即治疗作为预防），那么这是一个关键时刻。