Linking Infectious and Narcology Care in Russia

HIV Infection Clinical Trial

— LINC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01612455
• Other study ID #: H-30414
• Secondary ID: R01DA032082
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• HIV Infection
• HIV Infections

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Russian Federation	Botkin Infectious Disease Hospital	St. Petersburg
Russian Federation	City Addiction Hospital	St. Petersburg
Russian Federation	Pavlov State Medical University	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1) initiation of HIV care	Greater than or equal to 1 visit to HIV medical care within 6 months of enrollment	6 months
Primary	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
Primary	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
Primary	4) improved HIV health outcomes	CD4 cell count at 12 months (compared to CD4 cell count at baseline)	12 months
Primary	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