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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717856
• Other study ID #: CEPHEID-01
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: October 21, 2021

Study information

• Verified date: January 2021
• Source: Hasselt University
• Contact: Geert Robaeys, prof. dr.
• Phone: +32 89 32 65 05
• Email: geert.robaeys[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Use
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline
Secondary	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.	Baseline