Linking Infectious and Narcology Care in Russia

NCT ID: NCT01612455

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-01-31

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.

Conditions

HIV Infection; Drug Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

LINC Case Management (Intervention)

LINC Case Management (study Intervention) - see Intervention description

Group Type: EXPERIMENTAL

LINC Case Management

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Samet

Chief, Section of General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Samet, MD, MA, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Botkin Infectious Disease Hospital

Saint Petersburg, , Russia

City Addiction Hospital

Saint Petersburg, , Russia

Pavlov State Medical University

Saint Petersburg, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 27141834 (View on PubMed)

Other Identifiers

R01DA032082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-30414

Identifier Type: -

Identifier Source: org_study_id