Linking Infectious and Narcology Care-Part II

NCT03290391 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: H-36706R01DA045547
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV Infection; Drug Use

Keywords

Russia; Substance use; Peer case managers; ART; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Initiation of Antiretroviral Therapy (ART)

  Within 28 days of randomization

• Change in Mean CD4 Count From Baseline to 12 Months

  Change from baseline to 12 months

• Retention in HIV Care

  12 months

• Undetectable HIV Viral Load at 6 Months

  6 months

Study Arms (2)

LINC-II

EXPERIMENTAL

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; Drug: Pharmacotherapy for opioid use disorder; Behavioral: Strengths-based HIV case management

Standard of Care

NO INTERVENTION

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.

Interventions

Rapid ART initiation OTHER

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.

LINC-II

Pharmacotherapy for opioid use disorder DRUG

Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).

Also known as: Naltrexone

LINC-II

Strengths-based HIV case management BEHAVIORAL

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.

LINC-II

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

First St. Petersburg Pavlov State Medical University

Saint Petersburg, 197022, Russia

Location

City Addiction Hospital

Saint Petersburg, Russia

Location

Related Publications (4)

• Rosen S, Blokhina E, Truong V, Bereznicka A, Gnatienko N, Quinn E, Lioznov D, Krupitsky E, Michals A, Lunze K, Samet JH. Comparative costs and potential affordability of a multifaceted intervention to improve treatment outcomes among people with HIV who inject drugs in Russia: economic evaluation of the LINC-II randomized controlled trial. J Int AIDS Soc. 2024 Feb;27(2):e26208. doi: 10.1002/jia2.26208.

  PMID: 38403887 DERIVED

• Samet JH, Blokhina E, Cheng DM, Rosen S, Lioznov D, Lunze K, Truong V, Gnatienko N, Quinn E, Bushara N, Raj A, Krupitsky E. Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II): an open-label, randomised controlled trial. Lancet HIV. 2023 Sep;10(9):e578-e587. doi: 10.1016/S2352-3018(23)00143-1.

  PMID: 37659841 DERIVED

• 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.

  PMID: 36402082 DERIVED

• 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.

  PMID: 31931884 DERIVED

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Interventions

Drug Therapy; Naltrexone

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

Intervention Hierarchy (Ancestors)

Therapeutics; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Jeffrey Samet, MD MA MPH
• Organization: Boston Medical Center and BU Chobanian & Avedisian School of Medicine

jsamet@bu.edu

(617) 414-7288

Study Officials

• Jeffrey Samet, MD MA MPH

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: September 19, 2018
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)