N/A
Completed N=160
Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine
Source: ClinicalTrials.gov NCT05821413 ↗Enrolled (actual)
160
Serious AEs
4.4%
Results posted
Feb 2026
Primary outcomePrimary: Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits — 34; 58 Participants — p=<.001
Summary
The goal of this clinical trial is to study the preliminary effectiveness of a data to care intervention versus standard of care for people living with HIV in Ukraine. The main questions it aims to answer are:
* Does a data to care strategy improve primary outcomes of HIV care engagement, antiretroviral therapy initiation or re-initiation, and viral suppression among not-in-care people living with HIV?
* Does a data to care strategy improve secondary outcomes of engagement or re-engagement in ancillary services (e.g., drug treatment) and quality of life?
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits |
34; 58 | <.001 sig |
| PRIMARY Number of Participants Initiating ART (re-)Initiation |
80; 78 | .50 |
| PRIMARY Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication |
64; 40 | <.001 sig |
| PRIMARY Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test |
57; 54 | .73 |
| SECONDARY Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10) |
13; 33 | <.001 sig |
| SECONDARY Number of Participants With Moderate or Severe Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9) |
15; 20 | .34 |
| SECONDARY Health-Related Quality of Life as Assessed by SF12 |
48.5; 43.8 | .001 sig |
| SECONDARY HIV-related Risk Behaviors |
0; 0 | .57 |
| SECONDARY Trust in Physicians as Assessed by the Trust in Physician Scale (TPS) |
39.2; 38.5 | .64 |
Eligibility Criteria
Inclusion Criteria
- Registered in the Ukrainian Medical Information System as having received an HIV diagnosis at any time in the past
- missed a clinical visit (medication pick-up or other) more than 7 days ago
- registered with injection drug use (IDU) as probable mode of HIV transmission, or history of IDU documented at any clinical visit
- not been contacted by other clinical staff after the current missed visit
- 18 years or older
Exclusion Criteria
- Patient is already re-engaged in care and visited the clinic recently
- Patient has sufficient supply of medications (available to him for any reason)
- Patient moved to another clinic, city, country, or penitentiary institution
Data sourced from ClinicalTrials.gov (NCT05821413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.