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| Name | Class |
|---|---|
| Ziekenhuis Oost-Limburg | OTHER |
| Jessa Hospital | OTHER |
| Algemeen Ziekenhuis Vesalius | OTHER |
| CAD Limburg |
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The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population.
Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.
This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users.
Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV reinfection after DAA therapy in PWID | Experimental | Hepatitis C virus reinfection after directly acting antiviral treatment in persons who inject drugs. DAA therapy is an inclusion criteria, not an intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Blood sampling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reinfections in people who inject drugs after cure for hepatitis C infection with direct antiviral therapy | Number of reinfections with hepatitis C per 100 persons | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| questionnaire to Identify risk factors associated with HCV reinfection | day 1 | |
| questionaire to Identify risk factors associated with HCV reinfection | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geert Robaeys, prof. dr. | Contact | +32 89 32 15 60 | geert.robaeys@zol.be | |
| Rob Bielen, dr. | Contact | +32 89 32 15 60 | rob.bielen@zol.be |
| Name | Affiliation | Role |
|---|---|---|
| Geert Robaeys, prof. dr. | Hasselt University | Principal Investigator |
| Rob Bielen, dr. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Free Clinic Antwerp | Recruiting | Antwerp | 2000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34641896 | Derived | Busschots D, Bielen R, Koc OM, Heyens L, Verrando R, de Galocsy C, Van Steenkiste C, Nevens F, Midgard H, Dalgard O, Robaeys G. Hepatitis C reinfection in former and active injecting drug users in Belgium. Harm Reduct J. 2021 Oct 12;18(1):102. doi: 10.1186/s12954-021-00552-x. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
| Sint-Trudo | UNKNOWN |
| Free Clinic Antwerp | UNKNOWN |
| Ziekenhuis Netwerk Antwerpen (ZNA) | OTHER |
| Clinique Saint Joseph, Liège | OTHER |
| Centre Hospitalier Universitaire Saint Pierre | OTHER |
| Algemeen Ziekenhuis Maria Middelares | OTHER |
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| questionaires |
| Other |
Included participants will complete a baseline questionnaire at end of treatment (EOT) and a follow-up questionnaire throughout the follow-up period (Table 1). The questionnaires collect information on socio-demographics (age, gender, ethnicity, employment status, education level, housing status, incarceration, medical history and OST), injecting drug use (drugs injected, injection frequency and sharing of needle/syringe, cookers, cotton/filter or water). Details on the received DAA regime including mode of administration (direct observed therapy, pill box, etc.) and self-reported data on treatment adherence will also be recorded. |
|
| ZNA Stuivenberg | Recruiting | Antwerp | 2000 | Belgium |
|
| CHU Saint-Pierre | Recruiting | Brussels | 1000 | Belgium |
|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
|
| AZ Maria-Middelares | Recruiting | Ghent | 9000 | Belgium |
|
| CAD Limburg | Recruiting | Hasselt | 3500 | Belgium |
|
| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
|
| CHC Saint-Josephe, Liège | Recruiting | Liège | 4000 | Belgium |
|
| Sint-Trudo Ziekenhuis | Recruiting | Sint-Truiden | 3800 | Belgium |
|
| AZ Vesalius | Recruiting | Tongeren | 3700 | Belgium |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |