Implementation Science of a Data-to-Care Strategy to Improve HIV Continuum and Drug Treatment Outcomes for Out of Care PLWH in Ukraine

该项目的目标是开发和试点一项数据到护理的战略，以改善 在乌克兰的不在看护的PLWH。数据到医疗(D2C)是一项高影响力的公共卫生战略，它集成了 多个数据来源，例如来自医疗信息系统的临床数据、监视数据和持续数据 与客户一起进行病例管理评估，以确定哪些PLWH不在护理中，让他们参与护理，以及 管理艾滋病护理连续体。D2C策略是对艾滋病毒护理的循证实践的补充 通过整合艾滋病毒护理连续体上多个点的临床和病例管理数据来坚持， 使用系统评估来确定未得到满足的需求，如药物滥用治疗和使 适当的护理转诊，并使用数据为实践变化提供信息，并改善与 关心。D2C战略在美国各地的司法管辖区得到了有效实施，但 在乌克兰等低收入和中等收入国家(LMIC)，这不是护理标准。在乌克兰， 据估计，乌克兰约有24.4万艾滋病毒携带者，只有44%的人接受了抗逆转录病毒治疗。至少50% 乌克兰的PLWH通过静脉吸毒感染了艾滋病毒，很可能是注射毒品的活跃者 药物(PWID)。在HIV阳性的PWID中，抗逆转录病毒药物的使用率特别低，只有38%的人使用ART，28%的人使用ART 病毒被抑制了。本研究的具体目标是：(1)适应和发展D2C实施策略 乌克兰；(2)试行D2C策略与护理标准的随机临床试验；以及(3)评估 D2C战略的可行性、可接受性和与实施相关的进程和成果。我们将使用 在乌克兰PEPFAR指定的高优先级地区进行的整群随机对照试验(4个临床设置和 共有160人参加)。感兴趣的主要成果是：参与/重新参与艾滋病毒护理、MAT和其他 辅助护理服务；抗逆转录病毒治疗的启动/重新启动；以及病毒抑制。结果将在6点和6点进行评估 基线后12个月。乌克兰处于有利地位，可以确定D2C战略如何 在LMIC中实施。在PEPFAR等国际利益攸关方的支持下，乌克兰外交部 卫生部正在积极推动在艾滋病毒诊所一级使用医疗信息系统。管理信息系统 包含患者级别的信息，有关保留的艾滋病毒护理预约、药物处方、所有诊断为 发病率、临床和实验室检测结果。这种信息可以在D2C战略中动员起来， 在整个护理过程中跟踪患者，使用数据做出有关患者护理的决策并改善病例 管理实践，关注影响服药依从性的心理社会因素(例如，精神健康， )，并协调提供非临床社会服务。该项目旨在开发和测试 影响组织结构、气候和文化的干预措施，以促进传播和 采用循证做法；并评估适应进程和随后的有效性 在现实世界环境中实施的循证干预。

The goal of this project is to develop and pilot a data-to-care strategy to improve HIV care outcomes among not-in-care PLWH in Ukraine. Data-to-Care (D2C) is a high-impact public health strategy that integrates multiple sources of data such as clinical data from medical information systems, surveillance data, and ongoing case management assessments with clients to identify PLWH who are not in care, engage them in care, and manage the HIV Care Continuum. D2C strategies complement evidence-based practices for HIV care adherence by integrating clinical and case management data at multiple points along the HIV care continuum, using systematic assessments to identify unmet needs such as substance abuse treatment and make appropriate care referrals, and using data to inform practice changes and improve linkage to and retention in care. D2C strategies have been effectively implemented in jurisdictions throughout the United States but are not standard of care in low- and middle-income countries (LMICs) such as Ukraine. In Ukraine, of the approximately 244,000 estimated people living with HIV in Ukraine, only 44% are receiving ART. At least 50% of PLWH in Ukraine acquired HIV though intravenous drug use and are likely to be active people who inject drugs (PWID). ART use rates are particularly low among HIV-positive PWID, with only 38% on ART and 28% virally suppressed. This study’s Specific Aims are: (1) to adapt and develop a D2C implementation strategy for Ukraine; (2) to pilot a randomized clinical trial of a D2C strategy versus standard of care; and (3) to assess the feasibility, acceptability, and implementation-related processes and outcomes of the D2C strategy. We will use a cluster randomized control trial in PEPFAR-designated high priority regions in Ukraine (4 clinical settings and 160 total participants). Main outcomes of interest are: engagement/re-engagement in HIV care, MAT and other ancillary care service; ART initiation/re-initiation; and viral suppression. Outcomes will be assessed at 6 and 12- months post-baseline. Ukraine is well-positioned as a site to identify how D2C strategies can be implemented in LMICs. With the support of international stakeholders such as PEPFAR, the Ukrainian Ministry of Health is actively promoting the use of a medical information system (MIS) at the HIV clinic level. The MIS contains patient-level information on HIV care appointments kept, medication prescriptions, all diagnosed co- morbidities, and clinical and laboratory test results. This information can be mobilized in a D2C strategy that tracks patients through the care continuum, uses data to make decisions about patient care and improve case management practices, attends to psychosocial factors that affect medication adherence (e.g., mental health, addiction), and coordinates the provision of non-clinical social services. This project seeks to develop and test an intervention that influence organizational structure, climate, and culture to promote dissemination and adoption of evidence-based practices; and evaluate the adaptation process, and subsequent effectiveness of evidence-based interventions when implemented in real-world settings.