Linking Infectious and Narcology Care-Part II (LINC-II)

This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load suppression), impact on care systems and cost-effectiveness of the intervention.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Drug Use
• Intervention / Treatment: Other: Rapid ART initiation; Drug: Pharmacotherapy for opioid use disorder; Behavioral: Strengths-based HIV case management

Detailed Description

Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the world, with highest transmission risks among people who inject drugs (PWID) and their sexual partners. While routine HIV testing within addiction treatment systems in Russia (i.e., narcology hospitals) is the norm, links between the narcology and HIV care systems are limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this population less than 10% are on antiretroviral therapy (ART). For Russia to make progress toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is required. The objective of this study, "Linking Infectious and Narcology Care - Part II (LINC-II)," is to implement and evaluate, via a two-armed randomized controlled trial among 240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management.

The central hypothesis is that LINC-II will lead to marked progress toward the achievement of the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current standard of care, and that LINC-II will facilitate health system coordination of narcology and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed methods data from health care providers, administrators, and patients; and 3) evaluate the cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II approach both within Russia and other countries with HIV epidemics driven by injection drug use.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • St. Petersburg, Russian Federation, 197022
    • First St. Petersburg Pavlov State Medical University
  • St. Petersburg, Russian Federation
    • City Addiction Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older
• HIV infected
• Hospitalized at narcology hospital
• History of injection drug use
• Current diagnosis of opioid use disorder
• Provision of information for 2 contacts to assist with follow-up
• Address within 100 kilometers of St. Petersburg
• Possession of a telephone (home or cell)
• Able and willing to comply with all study protocols and procedures

Exclusion Criteria:

• Not fluent in Russian
• Cognitive impairment
• Pregnancy, planning to become pregnant, or breastfeeding
• ART use in past 30 days prior to hospitalization
• Known hypersensitivity to naltrexone
• Acute severe psychiatric illness (i.e. ,answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)
• Known history of liver failure
• ALT or AST >5 times the upper limit of normal
• Known severe thrombocytopenia (<50k)
• Known coagulation disorder/taking anticoagulation medications
• Body habitus that precludes intramuscular injection
• Known hypersensitivity to naloxone
• Known history of Raynaud's disease
• Known history of Itsenko-Cushing syndrome
• Known history of generalized mycoses
• Known history of glaucoma
• Known history of osteoporosis.
• Planned surgeries in the next 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LINC-II; LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems.	Other: Rapid ART initiation; The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.; Drug: Pharmacotherapy for opioid use disorder; Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).; Other Names: Naltrexone; Behavioral: Strengths-based HIV case management; Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.
No Intervention: Standard of Care; Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Undetectable HIV Viral Load at 12 Months	Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter)	12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of Antiretroviral Therapy (ART)	Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.	Within 28 days of randomization
Change in Mean CD4 Count From Baseline to 12 Months	The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results	Change from baseline to 12 months
Retention in HIV Care	Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record.	12 months
Undetectable HIV Viral Load at 6 Months	Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter).	6 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jeffrey Samet, MD MA MPH, Boston University

Publications and helpful links

General Publications

• Gnatienko N, Lioznov D, Raj A, Blokhina E, Rosen S, Cheng DM, Lunze K, Bendiks S, Truong V, Bushara N, Toussova O, Quinn E, Krupitsky E, Samet JH. Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia. Addict Sci Clin Pract. 2020 Jan 13;15(1):1. doi: 10.1186/s13722-020-0179-8.
• Bovell-Ammon BJ, Kimmel SD, Cheng DM, Truong V, Michals A, Vetrova M, Hook K, Idrisov B, Blokhina E, Krupitsky E, Samet JH, Lunze K. Incarceration history, antiretroviral therapy, and stigma: A cross-sectional study of people with HIV who inject drugs in St. Petersburg, Russia. Int J Drug Policy. 2023 Jan;111:103907. doi: 10.1016/j.drugpo.2022.103907. Epub 2022 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Russia; ART; Substance use; Peer case managers
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: H-36706; R01DA045547 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes