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

NCT ID: NCT05821413

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2024-11-13

Brief 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?

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Data to Care

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.

Group Type: EXPERIMENTAL

Data to care

Intervention Type: BEHAVIORAL

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 Care

Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

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

Interventions

Data to care

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.

Intervention Type: BEHAVIORAL

Standard of Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ukrainian Institute on Public Health Policy

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill Owczarzak, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Ukrainian Institute on Public Health Policy

Kyiv, , Ukraine

Countries

Ukraine

Other Identifiers

R34DA053143

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00018465

Identifier Type: OTHER

Identifier Source: secondary_id

00018465

Identifier Type: -

Identifier Source: org_study_id