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

HIV Clinical Trial

— MARTAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338024
• Other study ID #: 3U01GH000752-01
• Status: Completed
• Phase: N/A
• Start date: October 22, 2015
• Est. completion date: October 3, 2017

Study information

• Verified date: April 2021
• Source: Ukrainian Institute on Public Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: October 3, 2017
• Est. primary completion date: October 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV
• HIV Seropositivity

Intervention

Behavioral:
• Modified Antiretroviral Treatment Access Study intervention

Locations

Country	Name	City	State
Ukraine	Dermatovenereological dispensary	Dnipropetrovsk
Ukraine	Narcological dispensary	Dnipropetrovsk
Ukraine	Infectious disease clinic	Kryvyi Rih
Ukraine	Ukrainian Institute on Public Health Policy	Kyiv
Ukraine	Dermatovenereological dispensary	Mykolaiv
Ukraine	Infectious disease clinic	Mykolaiv
Ukraine	Narcological dispensary	Mykolaiv
Ukraine	Center of psychical health	Odesa
Ukraine	Dermatovenereological dispensary	Odesa
Ukraine	Infectious disease clinic	Odesa

Sponsors (1)

Lead Sponsor	Collaborator
Ukrainian Institute on Public Health Policy

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months