NCT04717856

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 21, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

November 26, 2020

Last Update Submit

January 20, 2021

Conditions

Drug UseHepatitis C

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The detection of HCV RNA

    Baseline

Study Arms (1)

drug users

OTHER
Other: screening: HCV RNA test and risk factors questionaire

Interventions

screening: HCV RNA test and risk factors questionaireOTHER

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

drug users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have recently or ever used drugs
  • Older than 18 years
  • Written informed consent

You may not qualify if:

  • Not being able to speak the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Central Study Contacts

Geert Robaeys, prof. dr.

CONTACT

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

Dana Busschots, drs.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2020

First Posted

January 22, 2021

Study Start

October 21, 2020

Primary Completion

October 21, 2021

Study Completion

October 21, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

BE(1)