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

Primary Purpose

HIV

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Modified Antiretroviral Treatment Access Study intervention
Sponsored by
Ukrainian Institute on Public Health Policy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatovenereological dispensary
  • Narcological dispensary
  • Infectious disease clinic
  • Ukrainian Institute on Public Health Policy
  • Dermatovenereological dispensary
  • Infectious disease clinic
  • Narcological dispensary
  • Center of psychical health
  • Dermatovenereological dispensary
  • Infectious disease clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MARTAS intervention

Standard of care

Arm Description

Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care.

Oral referrals to a network of government AIDS Centers or their departments ("Trust" offices) located in each study region.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2015
Last Updated
April 27, 2021
Sponsor
Ukrainian Institute on Public Health Policy
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1. Study Identification

Unique Protocol Identification Number
NCT02338024
Brief Title
Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
Acronym
MARTAS
Official Title
Enhancing Linkage to HIV Care for Newly Detected HIV-positive Persons in Ukraine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 22, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ukrainian Institute on Public Health Policy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MARTAS intervention
Arm Type
Experimental
Arm Description
Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Oral referrals to a network of government AIDS Centers or their departments ("Trust" offices) located in each study region.
Intervention Type
Behavioral
Intervention Name(s)
Modified Antiretroviral Treatment Access Study intervention
Primary Outcome Measure Information:
Title
The proportion of referred intervention patients who enroll in HIV care
Description
Linkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dermatovenereological dispensary
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Narcological dispensary
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Infectious disease clinic
City
Kryvyi Rih
Country
Ukraine
Facility Name
Ukrainian Institute on Public Health Policy
City
Kyiv
Country
Ukraine
Facility Name
Dermatovenereological dispensary
City
Mykolaiv
Country
Ukraine
Facility Name
Infectious disease clinic
City
Mykolaiv
Country
Ukraine
Facility Name
Narcological dispensary
City
Mykolaiv
Country
Ukraine
Facility Name
Center of psychical health
City
Odesa
Country
Ukraine
Facility Name
Dermatovenereological dispensary
City
Odesa
Country
Ukraine
Facility Name
Infectious disease clinic
City
Odesa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32333208
Citation
Neduzhko O, Postnov O, Sereda Y, Kulchynska R, Bingham T, Myers JJ, Flanigan T, Kiriazova T. Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage-to-Care Intervention Among HIV-Positive Patients in Ukraine. AIDS Behav. 2020 Nov;24(11):3142-3154. doi: 10.1007/s10461-020-02873-7.
Results Reference
derived

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

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