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

项目摘要/摘要 美国现有的艾滋病毒护理系统通常基于预定的预约，通常 不适合艾滋病毒携带者，他们在参与方面存在严重的心理社会和结构性障碍 在护理中(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 将这些人连接到一个不兼容的艾滋病毒护理系统，需要新的方法来减少 关爱参与的障碍，并提供更大的灵活性。在这项研究中，我们寻求实施一项证据- 知情的多组分临床干预，包括插播(即不预约)多学科艾滋病毒 初级保健、流动艾滋病毒护理、根据需要阶段性增加/降低护理强度，以及积极转诊 将患者从以社区为基础的临床和非临床站点转变为这种护理模式。这项临床干预 将在旧金山和阿拉米达县的四个不同的护理地点实施，这两个县都是优先考虑的 美国司法管辖区结束艾滋病毒流行(EHE)战略：学术安全网艾滋病毒诊所，针头 交流计划，以及两个联邦合格的健康中心。资格标准包括：1)当前的艾滋病毒病毒 负载≥200拷贝/毫升或停止抗逆转录病毒治疗，2)艾滋病毒护理参与度差的病史，以及3) 无家可归/住房不稳定，任何精神健康障碍，或任何非法物质。我们使用整合的 实施研究框架(CFIR)和RE-AIM实施框架 实施策略选择及我们的实施和临床效果评估。在目标1中，我们 将使用实施映射来评估实施的障碍和促进者，并召开关键会议 利益攸关方根据背景整合临床干预并最终确定实施策略。在AIM 2、我们将进行混合型2实施-效果研究，以评估临床效果 REACH(任何艾滋病毒初级保健访问)共同初级结果的干预实施和有效性 (任何HIV病毒载量&200拷贝/毫升)转诊到护理模式的患者超过12个月的随访 (n=400)，将结果与两个倾向分数匹配的对照组(400名同期对照)进行比较 使用公共卫生部的数据和在研究地点确定的400个历史对照来确定)。我们会 还要评估临床层面的实施结果。在目标3中，我们将评估和模拟个体、临床、 以及使用异质性和健康公平性分析的干预方法对人口水平的影响，成本/ 成本效益分析、最佳和减少组件方案的方案建模以及总体情况- 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，以改进 弱势人群中的艾滋病毒护理参与度。拟议的研究将提供强有力的证据，证明 即插即用/流动艾滋病毒护理方法和战略，以支持在不同的诊所实施。通过 将这些实施战略编成法典，以促进更广泛的实施，我们力求为 改善那些传统护理模式不太理想的患者的EHE治疗结果。

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.