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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
| CAD Limburg | UNKNOWN |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| case management | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Geert Robaeys, prof. dr. | Hasselt University | Principal Investigator |
| Rob Bielen, drs. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3590 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34416867 | Derived | 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. |
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| ID | Term |
|---|---|
| D015819 | Substance Abuse, Intravenous |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019090 | Case Management |
| ID | Term |
|---|---|
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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