Status:
COMPLETED
Linking Infectious and Narcology Care-Part II
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infection
Drug Use
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-i...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT03290391
Start Date
September 19 2018
End Date
April 6 2022
Last Update
April 18 2023
Active Locations (2)
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1
First St. Petersburg Pavlov State Medical University
Saint Petersburg, Russia, 197022
2
City Addiction Hospital
Saint Petersburg, Russia