Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine

Study Overview
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Brief Summary
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This study proposes to assess whether a modified Antiretroviral Treatment Access Study intervention, proved to be effective in the U.S. and based on the nurse case management approach, can impact the enrollment in HIV care of recently detected HIV-positive patients in specialized health care clinics in three regions in Ukraine, using the existing local infrastructure. The proposed study addresses a significant public health issue of non-/late enrollment of HIV-positive persons in HIV care and treatment.

Detailed Description
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Individual, parallel, two-arm, 1:1 RCT. The study participants were recruited between October 2015 and December 2016 at 9 clinics located in Dnipropetrovsk region (Dnipropetrovsk Regional Narcological Dispensary; Dnipropetrovsk Regional Dermatovenereologic Dispensary; Kryvyi Rih Infectious Disease Clinic No. 1), Mykolaiv region (Mykolaiv Regional Narcological Dispensary; Mykolaiv Regional Dermatovenereologic Dispensary; Mykolaiv Regional Infectious Disease Clinic), and Odesa region (Odesa Regional Dermatovenereologic Dispensary; Odesa Infectious Disease Clinic; Odesa Regional Center of Mental Health). These three types of clinical sites (treating addiction, sexually transmitted infections [STIs], and infectious diseases [IDs]) were located in the regions with the highest HIV prevalence in Ukraine, but were not co-located with HIV care facilities. Participants assigned to the standard of care (SOC) arm and the MARTAS arm received referrals to the local AIDS Centers (Dnipropetrovsk Regional AIDS Center, Kryvyi Rih AIDS Center, Mykolaiv Regional Center for Palliative Care and Integrated Services (former Mykolaiv AIDS Center), and Odesa Regional AIDS Center) or their departments (Trust offices) located in each study region. Investigators affiliated with The Ukrainian Institute on Public Health Policy (UIPHP) were responsible for all aspects of study design, management, and analysis.

Official Title
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Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Modified Antiretroviral Treatment Access Study intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ years; Tested HIV-positive Fluent in Russian or Ukrainian; Able to read/understand and sign an informed consent Exclusion Criteria: Enrolled in HIV care; Plan to move out of the study region before the end of their follow-up period Cognitive impairment Have pending legal issues, independent of their lifetime history of incarceration Subject is a part of another intervention or/and research study with similar linkage-to-care objectives

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: MARTAS intervention<br>Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care. | Behavioral: Modified Antiretroviral Treatment Access Study intervention<br> <br> |
| No Intervention: Standard of care<br>Oral referrals to a network of government AIDS Centers or their departments (Trust offices) located in each study region. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of referred intervention patients who enroll in HIV care | Linkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine