Linking Infectious and Narcology Care-Part II

Phase 4

Completed

Conditions: HIV Infection
Drug Use

Interventions: Other: Rapid ART initiation
Drug: Pharmacotherapy for opioid use disorder
Behavioral: Strengths-based HIV case management

Registration Number: NCT03290391

Lead Sponsor: Boston Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 225

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LINC-II	Rapid ART initiation	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.
LINC-II	Pharmacotherapy for opioid use disorder	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.
LINC-II	Strengths-based HIV case management	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Undetectable HIV Viral Load at 6 Months	6 months	Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (\<40 copies per milliliter).
Initiation of Antiretroviral Therapy (ART)	Within 28 days of randomization	Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
Change in Mean CD4 Count From Baseline to 12 Months	Change 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
Retention in HIV Care	12 months	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.

Trial Locations

Locations (2): First St. Petersburg Pavlov State Medical University
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St. Petersburg, Russian Federation
City Addiction Hospital
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St. Petersburg, Russian Federation