Linking Infectious and Narcology Care in Russia (LINC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Samet, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01612455
First received: June 1, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
HIV Infection
Drug Use
Behavioral: LINC Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 350
Study Start Date: July 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612455

Locations
Russian Federation
Pavlov State Medical University
St. Petersburg, Russian Federation
City Addiction Hospital
St. Petersburg, Russian Federation
Botkin Infectious Disease Hospital
St. Petersburg, Russian Federation
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Jeffrey Samet, MD, MA, MPH Boston Medical Center
  More Information

No publications provided

Responsible Party: Jeffrey Samet, Chief, Section of General Internal Medicine, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01612455     History of Changes
Other Study ID Numbers: R01DA032082, R01DA032082
Study First Received: June 1, 2012
Last Updated: June 20, 2014
Health Authority: United States: Federal Government

Keywords provided by Boston Medical Center:
HIV
drug addiction
Russia
case management

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 29, 2014