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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338024
Recruitment Status : Completed
First Posted : January 14, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Oleksandr Neduzhko, Ukrainian Institute on Public Health Policy

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Modified Antiretroviral Treatment Access Study intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
Actual Study Start Date : October 22, 2015
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: MARTAS intervention
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
No Intervention: Standard of care



Primary Outcome Measures :
  1. The proportion of referred intervention patients who enroll in HIV care [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338024


Locations
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Ukraine
Dermatovenereological dispensary
Dnipropetrovsk, Ukraine
Narcological dispensary
Dnipropetrovsk, Ukraine
Infectious disease clinic
Kryvyi Rih, Ukraine
Ukrainian Institute on Public Health Policy
Kyiv, Ukraine
Dermatovenereological dispensary
Mykolaiv, Ukraine
Infectious disease clinic
Mykolaiv, Ukraine
Narcological dispensary
Mykolaiv, Ukraine
Center of psychical health
Odesa, Ukraine
Dermatovenereological dispensary
Odesa, Ukraine
Infectious disease clinic
Odesa, Ukraine
Sponsors and Collaborators
Ukrainian Institute on Public Health Policy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oleksandr Neduzhko, Researcher, Ukrainian Institute on Public Health Policy
ClinicalTrials.gov Identifier: NCT02338024    
Other Study ID Numbers: 3U01GH000752-01 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Keywords provided by Oleksandr Neduzhko, Ukrainian Institute on Public Health Policy:
Enrollment in HIV care
Recently detected HIV-positive
specialized health care clinics
Ukraine
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents