Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs.

Trials
Håvard MidgardOlav Dalgard

Abstract

Scaled-up direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) infection among people who inject drugs (PWID) is crucial to reach the World Health Organization HCV elimination targets within 2030. One of the critical obstacles to HCV care in this population is the lack of treatment models within specialist healthcare adapted to marginalized individuals. OPPORTUNI-C is a pragmatic stepped wedge cluster randomized trial comparing the efficacy of immediate initiation of HCV treatment with the current standard of care among PWID admitted for inpatient care. Screening for HCV RNA will be performed as soon as possible after admission. The intervention includes immediate non-invasive liver disease assessment, counseling, and initiation of pan-genotypic DAA treatment with individualized follow-up. Standard of care is a referral to outpatient care at discharge. To mimic usual clinical practice as closely as possible, we will use a pragmatic clinical trial approach utilizing clinical infrastructure, broad eligibility criteria, flexible intervention delivery, clinically relevant outcomes, and collection of data readily available from the electronic patient files. The stepped wedge design involves a sequential rollout of the ...Continue Reading

Associated Clinical Trials

References

Jul 3, 2013·Nature Reviews. Gastroenterology & Hepatology·Behzad HajarizadehGregory J Dore
Aug 2, 2013·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Philip Bruggmann, Alain H Litwin
Feb 11, 2015·BMJ : British Medical Journal·K HemmingR J Lilford
Sep 8, 2015·Journal of Clinical Epidemiology·Karla Hemming, Monica Taljaard
Sep 17, 2015·Clinical Trials : Journal of the Society for Clinical Trials·Robert M Califf, Jeremy Sugarman
May 6, 2016·Nature Reviews. Gastroenterology & Hepatology·Matthias Götte, Jordan J Feld
Sep 20, 2016·Journal of Hepatology·Håvard MidgardOlav Dalgard
Jul 8, 2017·The International Journal on Drug Policy·Jason GrebelyUNKNOWN International Network on Hepatitis in Substance Users
Aug 24, 2017·Nature Reviews. Gastroenterology & Hepatology·Jason GrebelyGregory J Dore
Aug 30, 2018·Liver International : Official Journal of the International Association for the Study of the Liver·Emma DayUNKNOWN International Network on Hepatitis in Substance Users (INHSU)
Sep 25, 2018·The Lancet. Gastroenterology & Hepatology·Behzad HajarizadehJason Grebely
Jan 3, 2019·The Journal of Infectious Diseases·Jayna RaghwaniKatrina A Lythgoe
Jul 28, 2019·The International Journal on Drug Policy·Jason GrebelyUNKNOWN International Network on Hepatitis in Substance Users
Nov 5, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Evan B CunninghamUNKNOWN SIMPLIFY and D3FEAT study groups

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Citations

Jun 24, 2021·Substance Abuse : Official Publication of the Association for Medical Education and Research in Substance Abuse·Ximena A LevanderHonora Englander
Jun 10, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Heather ValerioGregory J Dore

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Methods Mentioned

BETA
PCR
blood

Clinical Trials Mentioned

NCT04220645

Software Mentioned

OPPORTUNI
proLAR
FibroScan®
HCV
STATA
GLUE
MinIon

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