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HIV InfectionsNCT05821413

Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine

A study testing Data to care in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Data to care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUkraine
Study dates
16 Jun 2023to 13 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ukraine1 site
  • Ukrainian Institute on Public Health Policy

    Kyiv, 21211

Other trials in Ukraine

About this study

Official title: Implementation, Evaluation, and Cost Effectiveness of a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care PLWH in Ukraine

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?
Read the detailed description

The goal of this project is to develop and pilot a data-to-care strategy to improve HIV care outcomes among HIV-positive people who inject drugs (PWID) 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 people living with HIV (PLWH) who are not in care, engage the participants 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 250,000 estimated people living with HIV in Ukraine, only 44% are receiving antiretroviral therapy (ART). At least 50% of PLWH in Ukraine acquired HIV though intravenous drug use and are likely to be active 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 a D2C implementation strategy for Ukraine; (2) to study preliminary effectiveness of a D2C strategy versus standard of care on primary outcomes of HIV care engagement, ART initiation or re-initiation, and viral suppression among not-in-care PWID living with HIV (n=160);and (3) to assess the feasibility, acceptability, implementation-related processes and costs of the D2C strategy. This study will use a cluster randomized control trial in high priority regions in Ukraine (4 clinical settings and 160 total participants). 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, 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.

Conditions
HIV Infections
Being tested
Data to care, Standard of Care
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data to careBehavioural

    Participants meet with a case manager who asks about health, basic needs such as housing and finances, and relationships and support systems. A score is assigned that reflects how much support is needed. A care plan is developed to address areas of need. The case manager meets regularly with participants to determine if needs are being met and identify strategies for meeting those needs. Participants with higher scores will receive more intensive contact with case managers, typically every month, until their level of need goes down. All participants will have their level and types of needs reassessed to determine if they need additional support or are moving toward self-management. Participants work with case managers for 6 months.

  • Standard of CareBehavioural

    Participants can use standard case management and other services offered by the clinic.

Study groups in NCT05821413
Study groupRoleWhat they receive
Data to CareExperimentalClinics randomized to the intervention arm will implement the data to care strategy, which includes a 5-step process: (1) identify not-in-care PLWH using the a medical information system, (2) verify eligibility criteria, (3) contact patients and invite to visit the clinic, (4) determine care status and reengage into care, and (5) provide case management services and confirm engagement in care.
Receives: Behavioral: Data to care
Standard of CareActive comparatorParticipants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits

    At least 3 clinical visits with at least 3 months apart within 12 months after study enrollment

    Measured: 12 months

  2. Number of Participants Initiating ART (re-)Initiation

    Initiating or re-initiating ART within 3 months after study enrollment

    Measured: 3 months

  3. Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication

    Number of participants ART adherent assessed by the percentage of days in possession of medication (pharmacy refill gap method)

    Measured: One month

  4. Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test

    Having at least one VL test with <200cp/ml and none with >=200cp/ml within 12 months after study enrollment

    Measured: 12 months

Secondary outcomes (5)
  1. Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10)

    The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool. Each question requires a yes or no response. This tool assesses drug use, not including alcohol or tobacco use. Scores of 0 indicates no problems; 1-2 indicates low level, 3-5 indicates moderate level, 6-8 indicates substantial level, and 9-10 is severe.

    Measured: 6 months

  2. Number of Participants With Moderate or Severe Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)

    The Patient Health Questionnaire (PHQ-9) assesses degree of depression severity. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. The PHQ-9 scores range from 0-27. Scores of 10 or higher are indicative of moderate or severe depressive symptoms.

    Measured: 6 months

  3. Health-Related Quality of Life as Assessed by SF12

    General Health Function as measured by the Physical Component of the Medical Outcomes Study SF-12. The t-scores are based on a standardized reference population with m = 50 and SD = 10. Higher scores indicate higher functioning.

    Measured: 6 months

  4. HIV-related Risk Behaviors

    HIV transmission risk score based on self-reported episodes of sexual intercourse. The score is the expected number of onward HIV transmissions over one year (X10000) estimated from Bernoulli transmission models. Higher scores indicate higher risk of onward HIV transmission. The index does not have an upper limit. The Lower limit is 0, and the observed range is 0 - 158.8.

    Measured: 6 months

  5. Trust in Physicians as Assessed by the Trust in Physician Scale (TPS)

    Assesses beliefs, opinions, and attitudes about doctors and health issues. The Trust in Physician Scale is an 11-item self-report instrument developed to assess an individual's trust in his/her physician. The items use a five point scale (1=Strongly Disagree to 5= Strongly Agree), and the scale has a possible range of 11-55 with higher scores indicating higher trust in physicians.

    Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start16 Jun 2023
  3. Primary completion13 Nov 2024
  4. Study completion13 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05821413
Sponsor's protocol ID
00018465
Other IDs
R34DA053143, IRB00018465
Status last verified
Jan 2026
First submitted
7 Apr 2023
Last updated
12 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dumchev K, Weir B, Prasad K, Fuller S, Rodrigues F, Burlaka J, Makarenko O, Kiriazova T, Owczarzak J. Feasibility and Preliminary Effectiveness of a Data-to-Care Intervention for HIV-Positive People Who Inject Drugs in Ukraine: A Pilot Cluster-Randomized Trial. AIDS Behav. 2026 Jul 15. doi: 10.1007/s10461-026-05224-0. Online ahead of print.

    PubMed 42455468

Questions about this trial

What is this clinical trial studying?

A study testing Data to care in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05821413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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Clinical Trial NCT05821413 | AzTrials