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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Modified Antiretroviral Treatment Access Study intervention

• Registration Number: NCT02338024
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-13
• Study First Posted: 2015-01-14
• Study Start: 2015-10-22
• Primary Completion: 2017-10-03
• Study Completion: 2017-10-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MARTAS intervention	Modified Antiretroviral Treatment Access Study intervention	Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care.

Primary Outcome Measures

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

Trial Locations

Locations (5)

Narcological dispensary; 🇺🇦 Mykolaiv, Ukraine

Dermatovenereological dispensary; 🇺🇦 Odesa, Ukraine

Ukrainian Institute on Public Health Policy; 🇺🇦 Kyiv, Ukraine

Center of psychical health; 🇺🇦 Odesa, Ukraine

Infectious disease clinic; 🇺🇦 Odesa, Ukraine