NCT03106194

Brief Summary

To study the impact of case management on the outcome of the care of chronic hepatitis C in people who inject drugs (PWID). By creating the function of case manager, the investigators will target all the barriers to care of the HCV care continuum. Partial objectives are to measure the impact of case management on the uptake for screening, the uptake and outcome of treatment, and the rate of reinfection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration 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

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

February 22, 2017

Last Update Submit

January 23, 2020

Conditions

Drug Abuse, Intravenous

Outcome Measures

Primary Outcomes (6)

  • Uptake for screening (%)

    percentage of clients screened in relation to number of clients in follow-up at CAD

    screening

  • Uptake for treatment assessment (%)

    percentage of HCV positive clients who attented a hepatology consultation in relation of total of HCV positive clients

    day 1

  • Uptake for treatment (%)

    percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment

    day 1

  • Compliance to therapy (%)

    percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment

    up to three years

  • Rate of sustained viral response (SVR) (%)

    percentage of patients who clear the hepatitis C virus in relation to total patients treated

    up to three years

  • Rate of reinfection (%)

    percentage of patients who get reinfected with HCV in relation to total cured patients

    up to three years

Study Arms (1)

history of injection drug use

OTHER

Men and women ≥ 18 years old with a history of injection drug use, enrolled in the opiate substitution program of CAD Limburg. Case management

Other: case management

Interventions

case managementOTHER
history of injection drug use

Eligibility Criteria

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

You may qualify if:

  • ≥ 18 years of age
  • History of injection drug use with substitution program
  • Written informed consent obtained

You may not qualify if:

  • Possible acute HCV infection within the previous 6 months defined by one of the following: acute hepatitis symptoms, ALT ≥ 10x ULN, negative or unknown HCV antibody status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3590, Belgium

Location

Related Publications (1)

  • Busschots D, Bielen R, Koc OM, Heyens L, Dercon E, Verrando R, Janssens F, Van den Bergh L, Van Lint P, Bruckers L, Nevens F, Robaeys G. On-site testing and case management to improve hepatitis C care in drug users: a prospective, longitudinal, multicenter study in the DAA era. BMC Public Health. 2021 Aug 20;21(1):1574. doi: 10.1186/s12889-021-11608-9.

    PMID: 34416867DERIVED

MeSH Terms

Conditions

Substance Abuse, Intravenous

Interventions

Case Management

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Geert Robaeys, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Rob Bielen, drs.

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

February 22, 2017

First Posted

April 10, 2017

Study Start

July 1, 2016

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

BE(1)