Clinical trial NCT05821413: Implementation a Data-to-Care Strategy to Improve HIV Continuum Outcomes for Out of Care People Living With HIV (PLWH) in Ukraine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Ukrainian Institute on Public Health Policy
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of participants engaged in HIV care as assessed by number of clinical visits
timeFrame: 12 months
measure: Number of participants initiating ART (re-)initiation
timeFrame: 3 months
measure: Number of participants ART adherent as assessed by the percentage of days in possession of medication
timeFrame: One month
measure: Number of participants with HIV Viral Suppression as assessed by viral load (VL) test
timeFrame: 12 months
Secondary outcomes:
measure: Substance use as assessed by the Drug Abuse Screening Test (DAST-10)
timeFrame: 3 months
measure: Depressive Symptoms as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: 2 weeks
measure: HIV Related Quality of Life as assessed by Patient Reported Outcome Measure (PROM)
timeFrame: one week
measure: Risk Behaviors as assessed by the Risk Behavior Assessment Scale
timeFrame: past 30 days
measure: Trust in Physicians as assessed by the Trust in Physician Scale (TPS)
timeFrame: One Year
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Ukrainian Institute on Public Health Policy
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Jill Owczarzak, PhD
role: PRINCIPAL_INVESTIGATOR
References: