Linking Infectious and Narcology Care in Russia

Study Overview
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Brief Summary
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The purpose of this study is to implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care.

Detailed Description
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The objective of this study Linking Infectious and Narcology Care (LINC) is to improve upon the treat and retain dimensions of the seek, test, treat, and retain paradigm in Eastern Europe. We will implement and assess a behavioral and structural intervention in Russia designed to support and motivate HIV-infected narcology heroin dependent patients (i.e., IDUs) to engage (i.e., initiate and retain) in HIV medical care and ultimately improve their HIV outcomes. LINC is a clinical model designed to coordinate narcology and HIV systems of care using elements shown to facilitate engagement in medical care: HIV case management and point-of-care CD4 testing. The central hypothesis is that an intervention that involves coordination between the narcology and HIV systems via HIV case management delivered by a peer to help motivate and reduce barriers to HIV care will lead to engagement in HIV care. Implementation research recognizes that effective interventions may not translate successfully across different contexts and systems. Hence, we will assess the organizational and operational issues that drive engagement in HIV care in Russia. The project will be undertaken by an international research team experienced in addressing HIV, substance use, and clinical interventions in Russia. This proposal's Specific Aims are to assess the effectiveness of the LINC intervention compared to standard of care on 4 distinct outcomes: 1) initiation of HIV care (> 1 visit to HIV medical care) within 6 months of enrollment; 2) retention in HIV care (> 1 visit to medical care in 2 consecutive 6 month periods) within 12 months; 3) appropriate HIV care (prescribed ART if CD4 cell count is <350 or having a second CD4 count if CD4 ≥350 within 12 months; and 4) improved HIV health outcomes (CD4 cell count at 12 months). The final Specific Aim is to establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia. If LINC can embed effectively within Eastern European medical systems, then it has the potential to be widely implemented in this region of the world and have a major impact on the HIV epidemic among IDUs.

Official Title
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Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes

Conditions
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HIV Infection, Drug Use

Intervention / Treatment
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* Behavioral: LINC Case Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 - 70 years HIV-infected hospitalized at a narcology hospital history of injection drug use available for CD4 testing has 2 contacts to assist with follow-up lives within 100 km of St. Petersburg, Russia has telephone willing to receive care at Botkin Infectious Disease Hospital Exclusion Criteria: currently on ART not fluent in Russian cognitive impairment precluding informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Control participants will receive the narcology hospital's standard of care. With regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care - the outpatient clinic that is involved in the intervention. Control patients will be referred to outpatient narcology care as part of standard of care. If control participants are newly diagnosed with HIV infection at the addiction hospital, they will receive HIV post test counseling consistent with CDC recommendations (this represents an enhancement of the current standard of care in Russia). | |
| Experimental: LINC Case Management (Intervention)<br>LINC Case Management (study Intervention) - see Intervention description | Behavioral: LINC Case Management<br>* The 1st case management (CM) session will be at the Narcology Hospital and will follow a modified strengths-based case management curriculum. As part of this first session, the CM will show a 10 minute video clip produced by a Russian NGO of HIV-infected patients talking about accessing HIV care. The CM will also tell the patient what his/her CD4 cell count is and discuss what it means with the patient. The case manager will help the client identify the outpatient HIV clinic on a map and will discuss basic drug harm reduction ideas with the client. The remaining 4 CM sessions will happen over the following 6 months. Sessions may happen at the HIV clinic, NGOs, or in the community. The HIV CM helps the client understand the importance of HIV care, identify barriers to care acquisition and recognize one's own strengths, abilities and assets to reduce self-identified barriers to care. The HIV CM's primary aim is to have the client attend an appointment at the HIV outpatient clinic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) initiation of HIV care | Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment | 6 months | 
| 2) retention in HIV care | Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months | 12 months | 
| 3) appropriate HIV care | prescribed ART if CD4 cell count is less than 350 or having a second CD4 count if CD4 is greater than or equal to 350 within 12 months (Note: As guidelines change over time, this outcome may be updated accordingly.) | 12 months | 
| 4) improved HIV health outcomes | CD4 cell count at 12 months (compared to CD4 cell count at baseline) | 12 months | 
| 5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia | Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, drug addiction, Russia, case management