Linking Infectious and Narcology Care-Part II

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Naltrexone

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