Clinical trial NCT03290391: Linking Infectious and Narcology Care-Part II
Official title: Linking Infectious and Narcology Care-Part II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Drug Use
Keywords: Russia
Substance use
Peer case managers
ART
HIV
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-09-21
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Undetectable HIV Viral Load at 12 Months
timeFrame: 12 months post randomization
Secondary outcomes:
measure: Initiation of Antiretroviral Therapy (ART)
timeFrame: Within 28 days of randomization
measure: Change in Mean CD4 Count From Baseline to 12 Months
timeFrame: Change from baseline to 12 months
measure: Retention in HIV Care
timeFrame: 12 months
measure: Undetectable HIV Viral Load at 6 Months
timeFrame: 6 months
Other outcomes:
Locations:
city: St. Petersburg
country: Russian Federation
facility: First St. Petersburg Pavlov State Medical University
city: St. Petersburg
country: Russian Federation
facility: City Addiction Hospital
Study officials:
affiliation: Boston University
name: Jeffrey Samet, MD MA MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.