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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Data to Care | Experimental | Clinics 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 Care | Active comparator | Participants 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.
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
Number of Participants Initiating ART (re-)Initiation
Initiating or re-initiating ART within 3 months after study enrollment
Measured: 3 months
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
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)
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
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
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
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
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.
- First posted20 Apr 2023
- Study start16 Jun 2023
- Primary completion13 Nov 2024
- Study completion13 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ukrainian Institute on Public Health Policy, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jill Owczarzak, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05821413
- Acronym / sponsor ID
- 00018465
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Ukrainian Institute on Public Health Policy, National Institute on Drug Abuse (NIDA)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 13 Nov 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data to Care | Experimental | Behavioral: Data to careClinics 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. |
| Standard of Care | Active comparator | Behavioral: Standard of CareParticipants in the standard of care sites will receive existing case management and supportive services from the HIV clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data to careParticipants 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. | Behavioural | Data to Care |
| Standard of CareParticipants can use standard case management and other services offered by the clinic. | Behavioural | Standard of Care |
Primary outcome
Number of Participants Engaged in HIV Care as Assessed by Number of Clinical Visits
Time frame: 12 months
At least 3 clinical visits with at least 3 months apart within 12 months after study enrollment
Number of Participants Initiating ART (re-)Initiation
Time frame: 3 months
Initiating or re-initiating ART within 3 months after study enrollment
Number of Participants ART Adherent as Assessed by the Percentage of Days in Possession of Medication
Time frame: One month
Number of participants ART adherent assessed by the percentage of days in possession of medication (pharmacy refill gap method)
Number of Participants With HIV Viral Suppression as Assessed by Viral Load (VL) Test
Time frame: 12 months
Having at least one VL test with <200cp/ml and none with >=200cp/ml within 12 months after study enrollment
5 secondary outcomes
Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10)
Time frame: 6 months
Number of Participants With Moderate or Severe Depressive Symptoms as Assessed by the Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Health-Related Quality of Life as Assessed by SF12
Time frame: 6 months
HIV-related Risk Behaviors
Time frame: 6 months
Trust in Physicians as Assessed by the Trust in Physician Scale (TPS)
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42455468Dumchev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Owczarzak, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
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.