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

Not Applicable

• Conditions: Drug Use; Hepatitis C

• Registration Number: NCT04717856
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Study First Submitted: 2020-11-26
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-10-21
• Study Completion: 2021-10-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Questionaire to determine the satisfaction of the use of the GenXpert	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

Name	Time	Method
The detection of HCV RNA	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.

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Diepenbeek, Belgium