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Case Management in HCV Infected PWID (CM-HCV)

Primary Purpose

Drug Abuse, Intravenous

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
case management
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Drug Abuse, Intravenous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

history of injection drug use

Arm Description

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

Outcomes

Primary Outcome Measures

Uptake for screening (%)
percentage of clients screened in relation to number of clients in follow-up at CAD
Uptake for treatment assessment (%)
percentage of HCV positive clients who attented a hepatology consultation in relation of total of HCV positive clients
Uptake for treatment (%)
percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment
Compliance to therapy (%)
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
Rate of sustained viral response (SVR) (%)
percentage of patients who clear the hepatitis C virus in relation to total patients treated
Rate of reinfection (%)
percentage of patients who get reinfected with HCV in relation to total cured patients

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
January 23, 2020
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg, CAD Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT03106194
Brief Title
Case Management in HCV Infected PWID
Acronym
CM-HCV
Official Title
Case Management in Hepatitis C Virus Infected People Who Inject Drugs in Belgium
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg, CAD Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Hepatitis C virus infection (HCV) is nowadays one of the leading causes of chronic liver disease, with prevalence of liver cirrhosis still increasing. The hepatitis C virus (HCV) is primarily transmitted through blood-to-blood contact. In the Western world, overall prevalence of HCV antibodies is low. In Belgium, prevalence of HCV in the general population is estimated around 1% by expert opinion. However, in high-risk populations prevalence of HCV increases. Data for HCV antibody prevalence in Belgium show rates of 60-80% in people who inject drugs (PWID). Populations at increased risk of HCV infection include: PWID recipients of infected blood products or invasive procedures in health-care facilities with inadequate infection control practices (western world: before 1992) children born to mothers infected with HCV people with sexual partners who are HCV-infected people with HIV infection prisoners or previously incarcerated persons people who have used intranasal drugs people who have had tattoos or piercings Based on international guidelines, the Belgian Association for the Study of the Liver (BASL) recommends targeted screening for these populations to assess HCV prevalence. This is not yet executed in Belgium, despite the severe health and economic burden accompanied with chronic hepatitis C virus infection (CHC). In response to this lacuna in the Belgium health care, the "Hepatitis C Plan (2014-2019)" was developed. This action plan aims to improve the following goals: Uptake for screening in high-risk populations Creation of a national systematic screening procedure Development of an HCV expertise network to improve care and linkage-to-care Furthermore, in April of 2015 the federal government of Belgium distributed a pact with the pharmaceutical industry, called "The Future Pact". This pact between industry and government focuses on accessibility to care, specifically for high-risk groups. Goals are to create a national registry for therapy and develop patient support programs, next to the expansion of reimbursement of therapy for HCV infection in fibrosis stadium II. However, despite the international guidelines and despite the strategic aims in the Hepatitis C plan and the Future Pact, no specific actions are described, and screening is not systematically executed in high-risk groups in Belgium. The importance of this screening cannot be underestimated as HCV is now curable, with success rates of 60-100% according to other associated factors (e.g. use of direct acting antivirals (DAAs), severity of liver disease, HCV genotype, resistance). Furthermore, different studies state that treatment of patients with CHC in an early stage has the potential to be cost-effective, as hospitalization costs after development of liver disease far exceed the cost of antiviral therapy. Nonetheless, treatment uptake also remains low. One of the reasons why PWIDs were excluded from treatment in the past was stigmatization based on greater risk of reinfection. Latest studies show low rates of reinfection among PWID, even with continued injection drug use during and after treatment. The pooled HCV reinfection risk was 2.4 per 100 person years, combined for six studies, across the UK, Australia, the Netherlands and Greece, suggesting that HCV treatment should not be withheld due to concerns about reinfection alone. However, with ongoing risk behaviour, current guidelines recommend monitoring with annual HCV RNA assessments. Furthermore, data from the National Scottish Hepatitis C Clinical Database show that an increasing significant minority of PWID continue to inject post-SVR at an intensity which leads to either hospitalisation or death and increased risk of reinfection. Thus, harm reduction and counselling remain necessary. With this trial, the investigators want to evaluate a possible approach to reach the different goals defined in the Hepatitis C plan and the future pact. The investigators will study the impact of case management on the outcome of care for HCV infected PWID in Belgium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Abuse, Intravenous

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
history of injection drug use
Arm Type
Other
Arm Description
Men and women ≥ 18 years old with a history of injection drug use, enrolled in the opiate substitution program of CAD Limburg. Case management
Intervention Type
Other
Intervention Name(s)
case management
Primary Outcome Measure Information:
Title
Uptake for screening (%)
Description
percentage of clients screened in relation to number of clients in follow-up at CAD
Time Frame
screening
Title
Uptake for treatment assessment (%)
Description
percentage of HCV positive clients who attented a hepatology consultation in relation of total of HCV positive clients
Time Frame
day 1
Title
Uptake for treatment (%)
Description
percentage of HCV positive clients who started treatment in relation of total of HCV positive clients needing treatment
Time Frame
day 1
Title
Compliance to therapy (%)
Description
percentage of patients reaching end-of treatment response, who present at the consultation, in relation to total patients in treatment
Time Frame
up to three years
Title
Rate of sustained viral response (SVR) (%)
Description
percentage of patients who clear the hepatitis C virus in relation to total patients treated
Time Frame
up to three years
Title
Rate of reinfection (%)
Description
percentage of patients who get reinfected with HCV in relation to total cured patients
Time Frame
up to three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria ≥ 18 years of age History of injection drug use with substitution program Written informed consent obtained Exclusion criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rob Bielen, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3590
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34416867
Citation
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.
Results Reference
derived

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Case Management in HCV Infected PWID

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