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

Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA Using a Finger Prick; a Cross-sectional, Multicentre Study Among Drug Users

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04717856

Enrollment

300

Registered

2021-01-22

Start date

2020-10-21

Completion date

2021-10-21

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Hepatitis C

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.

Interventions

OTHERscreening: 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Belgium

Contacts

Primary ContactGeert Robaeys, prof. dr.

geert.robaeys@zol.be+32 89 32 65 05

Backup ContactDana Busschots, drs.

dana.busschots@uhasselt.be+32 89 21 20 61

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026