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Completed

NCT Number: NCT01612455

Linking Infectious and Narcology Care in Russia

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.

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Key information

Conditions

HIV Infection Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Drug Use Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Botkin Infectious Disease Hospital, Saint Petersburg, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LINC Case Management

Behavioral

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.

Primary outcomes

  1. 1) initiation of HIV care

    Time frame: 6 months

    Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment

  2. 2) retention in HIV care

    Time frame: 12 months

    Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months

  3. 3) appropriate HIV care

    Time frame: 12 months

    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. 4) improved HIV health outcomes

    Time frame: 12 months

    CD4 cell count at 12 months (compared to CD4 cell count at baseline)

  5. 5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia

    Time frame: 4 years

    Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: LINC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 5, 2012
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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