Clinical trial NCT01612455: Linking Infectious and Narcology Care in Russia
Official title: Linking Russian Narcology & HIV Care to Enhance Treatment, Retention, & Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Drug Use
Keywords: HIV
drug addiction
Russia
case management
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-06-05
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 1) initiation of HIV care
timeFrame: 6 months
measure: 2) retention in HIV care
timeFrame: 12 months
measure: 3) appropriate HIV care
timeFrame: 12 months
measure: 4) improved HIV health outcomes
timeFrame: 12 months
measure: 5) Establish the contextual factors that influence adoption and sustainability of the LINC intervention in Russia
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: Botkin Infectious Disease Hospital
city: St. Petersburg
country: Russian Federation
facility: City Addiction Hospital
city: St. Petersburg
country: Russian Federation
facility: Pavlov State Medical University
Study officials:
affiliation: Boston Medical Center
name: Jeffrey Samet, MD, MA, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnatienko N, Han SC, Krupitsky E, Blokhina E, Bridden C, Chaisson CE, Cheng DM, Walley AY, Raj A, Samet JH. Linking Infectious and Narcology Care (LINC) in Russia: design, intervention and implementation protocol. Addict Sci Clin Pract. 2016 May 4;11(1):10. doi: 10.1186/s13722-016-0058-5.