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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02338024
Acronym
MARTAS
Enrollment
276
Registered
2015-01-14
Start date
2015-10-22
Completion date
2017-10-03
Last updated
2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

Enrollment in HIV care, Recently detected HIV-positive, specialized health care clinics, Ukraine

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.

Interventions

BEHAVIORALModified Antiretroviral Treatment Access Study intervention

Sponsors

Ukrainian Institute on Public Health Policy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The proportion of referred intervention patients who enroll in HIV care3 monthsLinkage (registration) to HIV care within the 3-month period after study enrollment-both self-reported and confirmed by the medical record.

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026