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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatovenereological dispensary, Dnipropetrovsk, Ukraine

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Antiretroviral Treatment Access Study intervention

Behavioral

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ukrainian Institute on Public Health Policy

Other

Registry information

Acronym: MARTAS

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Jan 14, 2015
Registry last updated: Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed