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

April 27, 2021 updated by: Oleksandr Neduzhko, Ukrainian Institute on Public Health Policy
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Dermatovenereological dispensary
      • Dnipropetrovsk, Ukraine
        • Narcological dispensary
      • Kryvyi Rih, Ukraine
        • Infectious disease clinic
      • Kyiv, Ukraine
        • Ukrainian Institute on Public Health Policy
      • Mykolaiv, Ukraine
        • Dermatovenereological dispensary
      • Mykolaiv, Ukraine
        • Infectious disease clinic
      • Mykolaiv, Ukraine
        • Narcological dispensary
      • Odesa, Ukraine
        • Center of psychical health
      • Odesa, Ukraine
        • Dermatovenereological dispensary
      • Odesa, Ukraine
        • Infectious disease clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Institute on Public Health Policy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2015

Primary Completion (Actual)

October 3, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3U01GH000752-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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