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

NCT ID: NCT04717856

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-10-21

Brief Summary

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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

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Conditions

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Drug Use Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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drug users

Group Type OTHER

screening: HCV RNA test and risk factors questionaire

Intervention Type OTHER

Screening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Geert Robaeys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hasselt University

Diepenbeek, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Geert Robaeys, prof. dr.

Role: CONTACT

+32 89 32 65 05

Dana Busschots, drs.

Role: CONTACT

+32 89 21 20 61

Facility Contacts

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Dana Busschots, drs.

Role: primary

+32 89 21 20 61

Other Identifiers

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CEPHEID-01

Identifier Type: -

Identifier Source: org_study_id

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