Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

描述(申请人提供)：HIV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，患者必须同时培养遵守HIV访问和遵守抗逆转录病毒治疗(ART)的行为技能，以实现血浆病毒载量(VL)的抑制。此外，在更广泛的背景下保持“对艾滋病毒的遵守”对于长期维持对VL的抑制至关重要，这对个人健康具有重要后果，并对艾滋病毒二级预防产生深远影响。令人震惊的是，在这个关键时刻，没有任何现有的循证干预措施支持同时发展患者信息、动机和行为技能，以支持艾滋病毒就诊和对抗逆转录病毒治疗的遵守。因此，我们将从针对这些独立遵守行为的现有、试点测试的干预措施中提取内容，以评估针对发起门诊艾滋病毒医疗护理的个人需求而量身定做的综合干预方法。拟议的iEngage干预措施(在进入时将参与度和坚持目标结合在一起)有两个总体目标：(1)促进患者适应新的艾滋病毒感染诊断，(2)发展必要的患者信息、动机和技能，以实现最佳的艾滋病毒访问和对抗逆转录病毒治疗的坚持。以下具体目标由统一的概念模型驱动，并与明确的测量工具和详细的分析计划相联系。目的1：将我们的试点测试和循证CDC保留护理和PACT遵守干预措施的内容整合到全面的iEngage干预措施中，以促进在新开始门诊HIV医疗护理的患者中抑制VL(&lt；50c/ml)。目的2：评估iEngage干预与标准护理在新开始门诊HIV医疗服务的患者中实现48周VL抑制(&lt；50c/mL)的效果。目的3：使用(A)亚组分析来估计重要的亚组效应，(B)使用边际结构模型来估计干预成分在总体效应中的作用，从而评估(A)iEngage有效性的修饰物和(B)介体。确定(C)以下各项的基线和纵向预测指标 在接受标准护理的患者中使用边际结构模型的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，成功地完成了这一创新工作范围。相当大的重视和资源适当地侧重于扩大艾滋病毒检测，干预措施在将社区患者与艾滋病毒诊所联系起来方面证明是有效的。相比之下，很少有干预研究集中在新开始门诊艾滋病毒医疗护理的患者身上。IEngage干预旨在将这段脆弱的时间转化为一个可教的时刻，在此期间，患者可以发展信息、动机和坚持技能，以实现并维持VL抑制。研究结果将在解决围绕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好处(即，治疗即预防)，这是一个关键时期。

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.