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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-22

Study Completion Date

2017-10-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MARTAS intervention

Structured motivational sessions and further communication between linkage coordinators and HIV-positive patients focused on engagement in HIV medical care.

Group Type EXPERIMENTAL

Modified Antiretroviral Treatment Access Study intervention

Intervention Type BEHAVIORAL

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modified Antiretroviral Treatment Access Study intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No