Phase 4
Completed N=225
Linking Infectious and Narcology Care-Part II
HIV · Drug Use
Source: ClinicalTrials.gov NCT03290391 ↗
Enrolled (actual)
225
Serious AEs
9.8%
Results posted
Apr 2023
Primary outcomePrimary: Undetectable HIV Viral Load at 12 Months — 46.9; 22.7 percentage of participants
◆ Published Evidence
Emerging
10citations · ~2 / year
Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia.
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.
Linked Publications (4)
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Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia.
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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.
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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.
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Incarceration history, antiretroviral therapy, and stigma: A cross-sectional study of people with HIV who inject drugs in St. Petersburg, Russia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Undetectable HIV Viral Load at 12 Months |
46.9; 22.7 | — |
| SECONDARY Initiation of Antiretroviral Therapy (ART) |
73.9; 11.4 | — |
| SECONDARY Change in Mean CD4 Count From Baseline to 12 Months |
56; -8 | — |
| SECONDARY Retention in HIV Care |
51.4; 35.1 | — |
| SECONDARY Undetectable HIV Viral Load at 6 Months |
35.4; 12.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT03290391) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.