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.

Project Narrative This proposed R34 study addresses a highly relevant public health question: how to identify people who are living with HIV who are not in care, assess their HIV medical and psychosocial support services need, and provide these individuals with the appropriate scope, type, and intensity of care and support to achieve ART adherence and viral suppression. This study will take place in Ukraine, which continues to experience one of the highest HIV rates in Eastern Europe and will use rapidly expanding medical information systems. The information gained through this study has the potential to inform expanded use of clinical data to improve HIV clinical outcomes among a highly vulnerable population.