Linking Infectious and Narcology Care in Russia
- Conditions
- HIV InfectionDrug Use
- Interventions
- Behavioral: LINC Case Management
- Registration Number
- NCT01612455
- Lead Sponsor
- Boston Medical Center
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
- 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
- currently on ART
- not fluent in Russian
- cognitive impairment precluding informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LINC Case Management (Intervention) LINC Case Management LINC Case Management (study Intervention) - see Intervention description
- Primary Outcome Measures
Name Time Method 1) initiation of HIV care 6 months Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment
2) retention in HIV care 12 months Greater than or equal 1 visit to medical care in 2 consecutive 6 month periods within 12 months
3) appropriate HIV care 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) improved HIV health outcomes 12 months 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 4 years Qualitative implementation science analysis, including pre-implementation focus groups, interviews, and surveys in Russia; post-implementation qualitative interviews in Russia.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Botkin Infectious Disease Hospital
🇷🇺St. Petersburg, Russian Federation
City Addiction Hospital
🇷🇺St. Petersburg, Russian Federation
Pavlov State Medical University
🇷🇺St. Petersburg, Russian Federation