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

NCT05821413 | Completed Results DMC

• 3 other identifiers: 00018465R34DA053143IRB00018465
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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?

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• 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

  12 months

• Number of Participants Initiating ART (re-)Initiation

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

  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)

  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

  12 months

Secondary Outcomes (5)

• Number of Participants With Substantial or Severe Substance Use as Assessed by the Drug Abuse Screening Test (DAST-10)

  6 months

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

  6 months

• Health-Related Quality of Life as Assessed by SF12

  6 months

• HIV-related Risk Behaviors

  6 months

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

  One Year

Study Arms (2)

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.

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.

Behavioral: Standard of Care

Interventions

Data to care 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.

Data to Care

Standard of Care BEHAVIORAL

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Institute on Public Health Policy: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Ukrainian Institute on Public Health Policy

Kyiv, 21211, Ukraine

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Jill Owczarzak
• Organization: Johns Hopkins University

jillowczarzak@jhu.edu

410-502-0026

Study Officials

• Jill Owczarzak, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: June 16, 2023
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)