Integrating ENGagement and Adherence Goals Upon Entry iENGAGE to Control HIV

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动态的、形成的和脆弱的时期。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）的抑制。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，对个人健康产生重大影响，并对艾滋病毒的二级预防产生深远影响。令人震惊的是，没有任何现有的循证干预措施支持在这一关键时刻同时发展患者信息、动机和行为技能，以促进艾滋病毒医疗就诊和坚持抗逆转录病毒治疗。因此，我们将从现有的试点测试干预措施中提取内容，这些干预措施针对这些单独的依从性行为，以评估针对个人开始门诊艾滋病毒医疗护理需求的综合干预方法。拟议的iENGAGE干预（整合入院时的参与和坚持目标）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就诊和抗逆转录病毒治疗坚持。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关联。目标1：整合我们的试点测试和基于证据的CDC保留护理和PACT ART依从性干预措施的内容，用于综合iENGAGE干预措施，以促进新开始门诊艾滋病毒医疗护理的患者的VL抑制（<50 c/mL）。目的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）的疗效。目的3：评估iENGAGE疗效的(a)修饰因子和(b)中介因子，使用(a)亚组分析来估计重要的亚组效应，(b)边际结构模型来估计干预成分在整体效果中的作用。确定(c)基线和纵向预测因素

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.