Linking Infectious and Narcology Care in Russia (LINC)

This study is currently recruiting participants.
Verified July 2013 by Boston Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01612455
First received: June 1, 2012
Last updated: July 30, 2013
Last verified: July 2013

June 1, 2012
July 30, 2013
July 2012
September 2015   (final data collection date for primary outcome measure)
  • 1) initiation of HIV care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment
  • 2) retention in HIV care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months
  • 3) appropriate HIV care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.)
  • 4) improved HIV health outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CD4 cell count at 12 months (compared to CD4 cell count at baseline)
  • 5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia and another Eastern European country (Ukraine) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualiatitve interviews in Russia; and formative evaluation in Ukraine
Same as current
Complete list of historical versions of study NCT01612455 on ClinicalTrials.gov Archive Site
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Linking Infectious and Narcology Care in Russia
Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes

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.

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 as well as a comparable setting in another former Soviet Union country, Ukraine.

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 and another Eastern European country. 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • HIV Infection
  • Drug Use
Behavioral: LINC Case Management
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.
  • No Intervention: Standard of Care
    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)
    LINC Case Management (study Intervention) - see Intervention description
    Intervention: Behavioral: LINC Case Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
April 2016
September 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Jeffrey Samet, MD, MA, MPH 617-414-7288 jsamet@bu.edu
Russian Federation
 
NCT01612455
R01DA032082, R01DA032082
No
Jeffrey Samet, Boston Medical Center
Boston Medical Center
National Institute on Drug Abuse (NIDA)
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
Boston Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP