Trial results for a study evaluating a data-to-care strategy to improve HIV continuum outcomes were posted on ClinicalTrials.gov on 2026-02-12. The strategy led to 64 participants demonstrating adherence to antiretroviral therapy (ART), compared to 40 in the standard of care group.
Background
Human Immunodeficiency Virus (HIV) infection requires consistent engagement in care and adherence to antiretroviral therapy (ART) to achieve viral suppression, improve health outcomes, and prevent transmission. A significant challenge in HIV care is re-engaging individuals who have fallen out of care. Strategies that leverage data to identify and support these individuals are crucial for improving public health outcomes, particularly in regions with high HIV prevalence. This study in Ukraine aimed to assess such a strategy.
Trial design
This completed study, which did not specify a phase (NA), enrolled 160 participants with HIV Infections in Ukraine. The trial compared a data-to-care strategy against standard of care for people living with HIV who were out of care. The primary goals were to determine if the data-to-care strategy could improve HIV care engagement, ART initiation or re-initiation, and viral suppression. Secondary goals included improving engagement in ancillary services like drug treatment and enhancing quality of life.
Key results
The trial results showed mixed outcomes for the data-to-care strategy:
- For "Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits," the Data to Care group had 34 participants, while the Standard of Care group had 58 participants. Statistical analysis yielded a p-value of 0.001, indicating a significant difference where standard care showed higher engagement.
- Regarding "Number of Participants Initiating ART (re-)Initiation," the Data to Care group had 80 participants, and the Standard of Care group had 78 participants. The p-value was 0.5, suggesting no significant difference between the groups for this outcome.
- For "Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication," the Data to Care group reported 64 participants, compared to 40 in the Standard of Care group. This difference was statistically significant with a p-value of 0.001.
- In terms of "Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test," there were 57 participants in the Data to Care group and 54 in the Standard of Care group. The p-value of 0.73 indicated no significant difference.
- For "Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10)," the Data to Care group had 13 participants, while the Standard of Care group had 33 participants. This was a statistically significant reduction in substance use for the Data to Care group, with a p-value of 0.001.
- Finally, for "Number of Participants With Moderate or Severe Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)," the Data to Care group had 15 participants, compared to 20 in the Standard of Care group. The p-value was 0.34, indicating no significant difference between the groups.
What this means
The findings suggest that a data-to-care strategy can be effective in improving specific aspects of HIV care for individuals who are out of care. Notably, the strategy significantly improved ART adherence and led to a substantial reduction in participants reporting substantial or severe substance use. These are critical outcomes for successful HIV management and overall patient well-being. However, the strategy did not show a significant advantage over standard care in improving viral suppression or depressive symptoms, and standard care actually resulted in higher rates of care engagement. These mixed results indicate that while data-to-care interventions hold promise, their implementation may require further optimization to achieve comprehensive improvements across all HIV continuum outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05821413, titled "Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine", were posted on 2026-02-12 on clinicaltrials.gov.