Linking Infectious and Narcology Care-Part II
Condition: HIV Infection; Drug Use
MeSH terms: HIV Infections
Intervention: Rapid ART initiation; Pharmacotherapy for opioid use disorder; Strengths-based HIV case management
Intervention description: 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.; Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).; 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.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Russia; Substance use; Peer case managers; ART; HIV

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.
    

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