Staged Low-Barrier and Mobile Care to Improve Retention and Viral Suppression in Hard-To-Reach Vulnerable People Living With HIV

分阶段进行低门槛和流动护理，以改善难以接触到的艾滋病毒感染者的保留和病毒抑制

• 批准号: 10663920
• 负责人: Katerina A Christopoulos
• 金额: $ 107.46万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-12 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663920
• 关键词: Address; Adoption; African American population; Appointment; Appointments and Schedules; Area; Black race; COVID-19 testing; COVID-19 vaccine; Caring; Case Management; Chronic; Clinic; Clinical; Clinical effectiveness; Communities; Community Healthcare; Complex; Consolidated Framework for Implementation Research; Control Groups; Cost Effectiveness Analysis; Costs and Cost Analysis; County; Criminal Justice; Data; Discipline of Nursing; Disparity; Drops; Effectiveness; Eligibility Determination; Epidemic; Evaluation; Federally Qualified Health Center; Food; Goals; HIV; Heterogeneity; Hispanic Populations; Homeless persons; Homelessness; Hybrids; Individual; Intervention; Knowledge; Latino; Learning; Literature; Maintenance; Maps; Medical; Medicine; Mental disorders; Methods; Modeling; Needle-Exchange Programs; Outcome; Patients; Persons; Pharmacy facility; Pilot Projects; Population; Population Sciences; Primary Care; Process; Psychiatry; Public Health; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recording of previous events; Research; Safety; San Francisco; Schedule; Site; Social Work; Structural Racism; Substance Use Disorder; Syringes; System; Testing; Treatment outcome; United States; Urban Population; Viral; Viral Load result; Vulnerable Populations; Work; addiction; antiretroviral therapy; barrier to care; care delivery; care systems; clinical effect; cohort; community burden; community clinic; design; effectiveness evaluation; effectiveness/implementation study; experience; flexibility; follow-up; health data; health equity; housing instability; implementation facilitators; implementation framework; implementation intervention; implementation outcomes; implementation research; implementation science; implementation strategy; implementation/effectiveness; improved; innovation; integrated care; interdisciplinary treatment approach; multidisciplinary; novel strategies; outreach; primary care visit; primary outcome; programs; psychosocial; safety net; service delivery; severe mental illness; substance use; treatment as usual

Project Summary/Abstract Existing HIV care systems in the United States, usually based on scheduled appointments, are often inadequate for people living with HIV who have significant psychosocial and structural barriers to engagement in care (i.e. homelessness/unstable housing, substance use disorders, severe mental illness). Rather than connect these individuals to an incompatible system of HIV care, new approaches are needed that reduce barriers to care engagement and offer increased flexibility. In this study, we seek to implement an evidence- informed multicomponent clinical intervention that includes drop-in (i.e. no appointments) multidisciplinary HIV primary care, mobile HIV care, staged escalation/de-escalation of care intensity as needed, and active referral of patients from community-based clinical and non-clinical sites into this care model. This clinical intervention will be implemented at four diverse care sites in San Francisco and Alameda counties, both priority jurisdictions in the U.S. Ending the HIV Epidemic (EHE) strategy: an academic safety net HIV clinic, a needle exchange program, and two federally qualified health centers. Eligibility criteria include: 1) current HIV viral load ≥200 copies/mL or off antiretroviral therapy, 2) history of poor HIV care engagement, and 3) homelessness/ unstable housing, any mental health disorder, or any illicit substance. We use the Consolidated Framework for Implementation Research (CFIR) and RE-AIM implementation frameworks to guide implementation strategy selection and our implementation and clinical effectiveness evaluation. In Aim 1, we will use implementation mapping to assess barriers and facilitators of implementation and convene key stakeholders to contextually integrate the clinical intervention and finalize the implementation strategies. In Aim 2, we will conduct a hybrid type 2 implementation-effectiveness study to evaluate the effect of clinical intervention implementation on co-primary outcomes of Reach (any HIV primary care visit) and Effectiveness (any HIV viral load <200 copies/mL) among patients referred to the care model over 12 months of follow-up (n=400), comparing outcomes to two propensity score matched control groups (400 contemporaneous controls identified using Department of Public Health data and 400 historical controls identified at study sites). We will also assess clinic-level implementation outcomes. In Aim 3, we will evaluate and model the individual, clinic, and population-level impacts of the intervention approach using heterogeneity and health equity analysis, cost/ cost-effectiveness analysis, scenario modeling of optimal and reduced component scenarios and population- level impact. Our multidisciplinary study team has a strong track record of implementation research to improve HIV care engagement among vulnerable populations. The proposed study will provide robust evidence for a drop-in/mobile HIV care approach and strategies to support implementation at a diverse set of clinic sites. By codifying these implementation strategies to facilitate wider-scale implementation, we seek to contribute to improving EHE Treatment outcomes among those for whom traditional models of care are sub-optimal.

项目总结/摘要 美国现有的艾滋病护理系统通常基于预约， 对于在参与方面存在重大心理和结构障碍的艾滋病毒感染者来说， （即无家可归/住房不稳定、药物使用障碍、严重精神疾病）。而不是 将这些人与不兼容的艾滋病毒护理系统联系起来，需要新的方法， 减少护理参与的障碍，并提高灵活性。在这项研究中，我们试图实现一个证据- 知情的多学科临床干预，包括直接（即无需预约）多学科艾滋病毒 初级保健、移动的艾滋病毒护理、根据需要分阶段提高/降低护理强度以及主动转诊 将社区临床和非临床站点的患者纳入这种护理模式。这种临床干预 将在旧金山弗朗西斯科和阿拉米达县的四个不同的护理点实施， 结束艾滋病毒流行（EHE）战略：一个学术安全网艾滋病毒诊所，一个针头 交换计划和两个联邦合格的健康中心。合格标准包括：1）目前的艾滋病毒 载量≥200拷贝/mL或停止抗逆转录病毒治疗，2）不良HIV护理参与史，以及3） 无家可归/不稳定的住房，任何精神健康障碍，或任何非法物质。我们利用联合 实施研究框架和RE-AIM实施框架， 实施策略的选择和我们的实施以及临床效果评价。目标1： 将使用执行情况摸底调查来评估执行的障碍和促进因素， 利益相关者根据具体情况整合临床干预并最终确定实施策略。在Aim中 2，我们将进行混合型2实施效果研究，以评估临床 干预措施在Reach（任何HIV初级保健就诊）和Effectiveness的共同主要结局上的实施 (any艾滋病毒载量<200拷贝/mL），在12个月的随访中， （n=400），将结果与两个倾向评分匹配的对照组（400个同期对照组）进行比较 使用公共卫生部数据和研究中心确定的400个历史对照确定）。我们将 还评估了临床层面的实施结果。在目标3中，我们将评估和建模个人，诊所， 使用异质性和健康公平性分析，成本/ 成本效益分析，最佳和减少组成部分的情景和人口的情景建模- 水平影响。我们的多学科研究团队在实施研究方面有着良好的记录， 在弱势群体中开展艾滋病毒护理工作。拟议的研究将提供有力的证据， 在不同的诊所实施的直接/移动的艾滋病毒护理方法和战略。通过 为了编纂这些执行战略，以促进更广泛的执行，我们力求促进 改善传统护理模式不理想的患者的EHE治疗结果。