Back to resultsEvaluation of the Use of the GenXpert to Detect Hepatitis C RNA
Primary Purpose
Drug Use, Hepatitis C
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
screening: HCV RNA test and risk factors questionaire
Sponsored by
About this trial
This is an interventional screening trial for Drug Use
Eligibility 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
Sites / Locations
- Hasselt UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
drug users
Arm Description
Outcomes
Primary Outcome Measures
Questionaire to determine the satisfaction of the use of the GenXpert
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
The detection of HCV RNA
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04717856
Brief Title
Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
October 21, 2021 (Anticipated)
Study Completion Date
October 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Use, Hepatitis C
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drug users
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
screening: HCV RNA test and risk factors questionaire
Intervention Description
Screening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors.
Primary Outcome Measure Information:
Title
Questionaire to determine the satisfaction of the use of the GenXpert
Description
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
Time Frame
baseline
Secondary Outcome Measure Information:
Title
The detection of HCV RNA
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geert Robaeys, prof. dr.
Phone
+32 89 32 65 05
Email
geert.robaeys@zol.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Busschots, drs.
Phone
+32 89 21 20 61
Email
dana.busschots@uhasselt.be
Facility Information:
Facility Name
Hasselt University
City
Diepenbeek
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Busschots, drs.
Phone
+32 89 21 20 61
Email
dana.busschots@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Geert Robaeys, prof. dr.
First Name & Middle Initial & Last Name & Degree
Dana Busschotes, drs.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA
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