Feasibility and Preliminary Effectiveness of a Data-to-Care Intervention for HIV-Positive People Who Inject Drugs in Ukraine: A Pilot Cluster-Randomized Trial

Antiretroviral therapy (ART) interruptions are common among people who inject drugs (PWID) and contribute to viral rebound, disease progression, and onward transmission. Data-to-Care (D2C) strategies, which use routine health data to identify and re-engage people living with HIV who have fallen out of care, are widely used in high-income settings but rarely evaluated in low- and middle-income countries. We piloted a Ukrainian Data-to-Care (UD2C) intervention integrated into the national HIV Medical Information System among HIV-positive PWID recently out of care. Four specialized HIV clinics were randomized to UD2C or care as usual (CAU), with 40 participants enrolled per clinic (n = 160). UD2C combined an optimized data query to identify out-of-care patients with multidisciplinary, acuity-based case management. Recruitment, data extraction, and intervention delivery were feasible across all clinics. Because recruitment required clinic attendance, the pilot assessed UD2C's post-linkage care component rather than its re-engagement function. The primary analysis accounted for clinic-level clustering using cluster-robust standard errors. Median ART coverage during follow-up was higher in UD2C than CAU (97% vs. 89%; adjusted rate ratio 1.15, 95% CI 0.87-1.51); this difference was significant in the model-based sensitivity analysis but not in the primary clustered analysis. Viral suppression was achieved or maintained more often in UD2C than CAU (58.8% vs. 28.8%; adjusted odds ratio 4.6, 95% CI 1.76-12.1). The UD2C model was feasible to implement and evaluate using a cluster-randomized design and showed promising improvements in longitudinal viral suppression. A fully powered definitive trial is warranted to confirm effectiveness and inform national scale-up. The trial is registered at www.clinicaltrials.gov as NCT05821413.