NCT02755402

Brief Summary

Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population. The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly. By using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit. The aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

April 20, 2016

Last Update Submit

July 26, 2021

Conditions

Hepatitis CIntravenous Drug Users

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who initiate treatment after first visit

    Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls

    1 year

Secondary Outcomes (8)

  • Proportion of patients who attend at least two visits in 6 months

    6 months

  • Proportion of patients who initiate opioid substitution therapy during follow-up

    6 months

  • Difference in number of injection between the month prior to study entry and the last month of follow-up

    6 months

  • Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment

    12 weeks post-treatment

  • Proportion of patients with a re-infection within six months of end-of-treatment

    6 months post-treatment

  • +3 more secondary outcomes

Study Arms (1)

Rapid evaluation

EXPERIMENTAL

Transient elastography, Xpert HCV Viral load, medical and nurse visits

Device: Xpert HCV Viral loadDevice: Transient elastography

Interventions

Xpert HCV Viral loadDEVICE

HCV viral load testing

Rapid evaluation
Transient elastographyDEVICE

Evaluation of liver fibrosis

Rapid evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Person who inject drugs, defined as having injected in the past year
  • Able to give an informed consent
  • Unknown treatment eligibility status

You may not qualify if:

  • Patients actively engaged in HCV follow up
  • Patients visibly intoxicated at initial study visit
  • Pregnant or breastfeeding women
  • Pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J4, Canada

Location

Related Publications (1)

  • Martel-Laferriere V, Brissette S, Wartelle-Bladou C, Juteau LC, Popa M, Goyer ME, Bruneau J. Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs. Subst Abuse. 2022 Aug 12;16:11782218221119068. doi: 10.1177/11782218221119068. eCollection 2022.

    PMID: 35990750DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Valérie Martel-Laferrière, MD, MSc

    CRCHUM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical microbiologist

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 28, 2016

Study Start

January 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Locations

CA(1)