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

Abstract

Background: 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. Methods: 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 intervention over 16 months, in which seven participating clusters will be randomized from standard of care to intervention in a stepwise manner. Randomization will be stratified according to cluster size to keep high prevalence clusters separated. The trial will include approximately 220 HCV RNA positive individuals recruited from departments of

Peer support in small towns: A decentralized mobile Hepatitis C virus clinic for people who inject drugs

“…For instance, a recent RCT on integrated HCV treatment in OAT reported 72% treatment uptake in the standard of care arm with treatment provided at a hospital outpatient clinic 48 . Preliminary results from an ongoing trial of immediate treatment among hospitalized PWID indicate that only 30% of individuals referred to standard outpatient carecompleted treatment within 6 months 49 . Finally, treatment uptake after 7 years of ambulant work among HCV RNA positive PWID in a low‐threshold clinic in downtown Oslo was 74% 16 …”

“…48 Preliminary results from an ongoing trial of immediate treatment among hospitalized PWID indicate that only 30% of individuals referred to standard outpatient carecompleted treatment within 6 months. 49 Finally, treatment uptake after 7 years of ambulant work among HCV RNA positive PWID in a low-threshold clinic in downtown Oslo was 74%. 16 Evidence from qualitative studies and RCTs show that peer support is valuable to remove barriers to HCV care, including stigma, and to improve engagement with healthcare services.…”

Exploring how Hospitalization Can Alter Hepatitis C Virus Treatment Prioritization and Trajectories in People who Use Drugs: A Qualitative Analysis

“…An area of future policy advocacy could include changes to this repayment structure to improve population-level HCV elimination efforts. Studies are underway internationally to investigate the effectiveness of initiating HCV treatment during admission 47 . Hospitalization could serve as a time to complete needed testing for those wanting to start HCV treatment right away and is an important area of future study.…”

“…Studies are underway internationally to investigate the effectiveness of initiating HCV treatment during admission. 47 Hospitalization could serve as a time to complete needed testing for those wanting to start HCV treatment right away and is an important area of future study. Given many participants voicing desire for HCV information, interventions to improve knowledge of hospital-based clinicians around HCV treatment eligibility are worth exploring.…”

Opportunistic Treatment of Hepatitis C Infection Among Hospitalized People Who Inject Drugs (OPPORTUNI-C): A Stepped Wedge Cluster Randomized Trial

“…Seven departments (clusters) of internal medicine (n = 3), addiction medicine (n = 2), and psychiatry (n = 2) at 3 hospitals in Oslo, Norway, were assigned to change from control (standard of care) to intervention conditions in a random order until all clusters were exposed to the intervention ( Supplementary Figure 1 ). The study protocol has been published previously [ 22 ] and a full methods description is available in the Supplementary materials and the Statistical Analysis Plan. The study was registered with ClinicalTrials.gov (NCT04220645) on 1 October 2019.…”