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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Data to care
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Data to Care<br>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<br>* 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.<br>|
| Active Comparator: Standard of Care<br>Participants in the standard of care sites will receive existing case management and supportive services from the HIV clinic. | Behavioral: Standard of Care<br>* Participants can use standard case management and other services offered by the clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Patients receive 1 point for every yes answer with the exception of question #3, for which a no answer receives 1 point. 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. | 3 months | 
| 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. Higher scores indicate more depressive symptoms. | 2 weeks | 
| HIV Related Quality of Life as assessed by Patient Reported Outcome Measure (PROM) | HIV Related Quality of Life a new Patient Reported Outcome Measure (PROM) that has been developed to assess the quality of life. | one week | 
| Risk Behaviors as assessed by the Risk Behavior Assessment Scale | Assess drug use and sex-related HIV risk behaviors and patterns. | past 30 days | 
| 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 measure uses a five point scale (1=Strongly Disagree to 5= Strongly Agree). | One Year |