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Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717856
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Geert Robaeys, Hasselt University

Study Description
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Brief Summary:
The results of the GX device are equivalent to standard venous blood sampling. With this study we are going to determine the prevalence in drug users with difficult venous access. On the other hand, we want to look at the place this device can have in primary care.

Condition or disease Intervention/treatment Phase
Drug Use Hepatitis C Other: screening: HCV RNA test and risk factors questionaire Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA Using a Finger Prick; a Cross-sectional, Multicentre Study Among Drug Users
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : October 21, 2021
Estimated Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
drug users Other: screening: HCV RNA test and risk factors questionaire
Screening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors.


Outcome Measures
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Primary Outcome Measures :
  1. Questionaire to determine the satisfaction of the use of the GenXpert [ Time Frame: baseline ]
    1. To determine how the caregiver and the client experience the use of the GenXpert and what place the device can have in primary care. a. A questionnaire to determine the satisfaction of the user and the person tested


Secondary Outcome Measures :
  1. The detection of HCV RNA [ Time Frame: Baseline ]
    a. One finger prick to measure the HCV RNA. These blood samples are processed directly using the HCV Viral Load fingerstick cartridge which is processed via the GenXpert device.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have recently or ever used drugs
  • Older than 18 years
  • Written informed consent

Exclusion Criteria:

  • Not being able to speak the Dutch language
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04717856


Contacts
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Contact: Geert Robaeys, prof. dr. +32 89 32 65 05 geert.robaeys@zol.be
Contact: Dana Busschots, drs. +32 89 21 20 61 dana.busschots@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Diepenbeek, Belgium, 3590
Contact: Dana Busschots, drs.    +32 89 21 20 61    dana.busschots@uhasselt.be   
Principal Investigator: Geert Robaeys, prof. dr.         
Sub-Investigator: Dana Busschotes, drs.         
Sponsors and Collaborators
Hasselt University
More Information
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Responsible Party: Geert Robaeys, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04717856    
Other Study ID Numbers: CEPHEID-01
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections