Linking Infectious and Narcology Care in Russia

NCT01612455 | Completed

• 2 other identifiers: H-30414R01DA032082
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 3

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.

Conditions

HIV Infection; Drug Use

Keywords

HIV; drug addiction; Russia; case management

Outcome Measures

Primary Outcomes (5)

• 1) initiation of HIV care

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

  6 months

• 2) retention in HIV care

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

  12 months

• 3) appropriate HIV care

  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.)

  12 months

• 4) improved HIV health outcomes

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

  12 months

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

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

  4 years

Study Arms (2)

Standard of Care

NO INTERVENTION

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).

LINC Case Management (Intervention)

EXPERIMENTAL

LINC Case Management (study Intervention) - see Intervention description

Behavioral: LINC Case Management

Interventions

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.

LINC Case Management (Intervention)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• currently on ART
• not fluent in Russian
• cognitive impairment precluding informed consent

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Botkin Infectious Disease Hospital

Saint Petersburg, Russia

Location

City Addiction Hospital

Saint Petersburg, Russia

Location

Pavlov State Medical University

Saint Petersburg, Russia

Location

Related Publications (1)

• 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.

  PMID: 27141834 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jeffrey Samet, MD, MA, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of General Internal Medicine

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 5, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 21, 2018

Record last verified: 2018-06

Locations

RU (3)