Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

描述（由申请人提供）：门诊艾滋病毒医疗护理的第一年是一个动态的，形成和脆弱的时间。在适应改变生活的诊断的同时，患者必须同时发展HIV访视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，对个人健康具有重要影响，并对二级艾滋病毒预防产生深远影响。令人震惊的是，在这一关键时刻，没有任何现有的循证干预措施支持同时发展艾滋病毒医疗访问和抗逆转录病毒治疗依从性的患者信息，动机和行为技能。因此，我们将从我们现有的，试点测试的干预措施，针对这些单独的依从性行为，以评估一个综合的干预方法，适合个人的需要，启动门诊艾滋病毒医疗护理。拟议的iENGAGE干预（在入组时整合ENGYSIDE和依从性目标）有两个首要目标：（1）促进患者适应新的HIV感染诊断，以及（2）开发必要的患者信息，动机和技能，以实现最佳的HIV访视和ART依从性。以下具体目标是由一个统一的概念模型驱动的，与明确的测量工具和详细的分析计划相联系。目标1：整合我们的试点测试和循证CDC保留护理和PACT ART依从性干预措施的内容，用于综合iENGAGE干预，以促进新开始门诊HIV医疗护理的患者中的VL抑制（<50 c/mL）。目标二：在新开始门诊HIV医疗护理的患者中，评价iENGAGE干预与标准治疗在实现48周VL抑制（<50 c/mL）方面的疗效。目标3：评价iENGAGE疗效的（a）调节因子和（B）介导因子，使用（a）亚组分析估计重要的亚组效应，使用（B）边际结构模型估计干预成分在总体效应中的作用。确定（c）基线和纵向预测因素 在接受标准治疗的患者中使用边缘结构模型的VL结局。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有着良好的合作记录和集体专业知识，能够成功完成这一创新范围的工作。相当多的重点和资源适当地集中在扩大艾滋病毒检测上，干预措施在将社区病人与艾滋病毒诊所联系起来方面证明是有效的。与此相反，干预研究的重点是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化为一个可教的时刻，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个人和人群健康益处，这是一个关键时刻（即，治疗作为预防）VL抑制。

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.