Feasibility and Preliminary Effectiveness of a Data-to-Care Intervention for HIV-Positive People Who Inject Drugs in Ukraine: A Pilot Cluster-Randomized Trial
4 affiliations
- 1Ukrainian Institute on Public Health Policy, 10 Bohdana Khmelnytskoho Str., Office 60, 01054 Kyiv, Ukraine
- 2National University of Kyiv-Mohyla Academy, Kyiv, Ukraine
- 3Department of Health, Behavior & Society, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA
- 4Department of Public Health Education, University of North Carolina Greensboro, Greensboro, NC, USA
Abstract
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.
Related
- SOFTPEERS: feasibility, acceptability, and preliminary effectiveness of a peer-led intervention to prevent binge drinking in adolescents. Results from a mixed-methods pilot cluster-randomized controlled trial
- Feasibility and Preliminary Effectiveness of a Health and Wellbeing Intervention for Adults With Mild to Moderate Intellectual Disabilities.
- Acceptability, Feasibility, and Preliminary Efficacy of a Digital Cognitive Intervention for Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) in Older Adults
- Feasibility, Safety, and Preliminary Efficacy of Partnered Rhythmic Rehabilitation in Prodromal Alzheimer's Disease: A 12-Month Pilot Randomized Controlled Trial
- Evaluating the Feasibility, Acceptability, and Preliminary Effectiveness of Interprofessional Enhanced Cognitive Behavior Therapy for Anorexia Nervosa and Atypical Anorexia Nervosa: A Pilot Study
BibTeX
@article{dumchev2026feasibility,
title = {{Feasibility and Preliminary Effectiveness of a Data-to-Care Intervention for HIV-Positive People Who Inject Drugs in Ukraine: A Pilot Cluster-Randomized Trial}},
author = {Kostyantyn Dumchev and Brian Weir and Khushee Prasad and Shannon Fuller and Farren Rodrigues and Julia Burlaka and Olena Makarenko and Tetiana Kiriazova and Jill Owczarzak},
journal = {AIDS and behavior},
year = {2026},
month = jul,
doi = {10.1007/s10461-026-05224-0},
url = {https://doi.org/10.1007/s10461-026-05224-0},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Feasibility and Preliminary Effectiveness of a Data-to-Care Intervention for HIV-Positive People Who Inject Drugs in Ukraine: A Pilot Cluster-Randomized Trial
AU - Kostyantyn Dumchev
AU - Brian Weir
AU - Khushee Prasad
AU - Shannon Fuller
AU - Farren Rodrigues
AU - Julia Burlaka
AU - Olena Makarenko
AU - Tetiana Kiriazova
AU - Jill Owczarzak
PY - 2026
DA - 2026/07/15
JO - AIDS and behavior
DO - 10.1007/s10461-026-05224-0
UR - https://doi.org/10.1007/s10461-026-05224-0
AB - 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.
SN - 1090-7165
SN - 1573-3254
ER -