Drug UseNCT04717856
Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA
A study testing screening: HCV RNA test and risk factors questionaire in people with Drug Use and Hepatitis C, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Use, Hepatitis C
- What is being tested?
- screening: HCV RNA test and risk factors questionaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Oct 2020to 21 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have recently or ever used drugs
- Older than 18 years
- Written informed consent
Who cannot join
- Not being able to speak the Dutch language
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Diepenbeek, 3590
Dana Busschots, drs., +32 89 21 20 61, dana.busschots@uhasselt.be
Geert Robaeys, prof. dr.
About this study
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
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.
- Conditions
- Drug Use, Hepatitis C
- Being tested
- screening: HCV RNA test and risk factors questionaire
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| drug users | Other | Not described Receives: Other: screening: HCV RNA test and risk factors questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionaire to determine the satisfaction of the use of the GenXpert
- 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
Measured: baseline
Secondary outcomes (1)
The detection of HCV RNA
- 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start21 Oct 2020
- Primary completion21 Oct 2021 (estimated)
- Study completion21 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geert Robaeys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717856
- Sponsor's protocol ID
- CEPHEID-01
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04717856
- Acronym / sponsor ID
- CEPHEID-01
- Conditions
- Drug Use, Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 21 Oct 2021 (estimated)
- Study completion
- 21 Oct 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug users | Other | Other: screening: HCV RNA test and risk factors questionaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have recently or ever used drugs
- Older than 18 years
- Written informed consent
Key exclusion criteria (1 listed)
- Not being able to speak the Dutch language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening: HCV RNA test and risk factors questionaireScreening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors. | Other | drug users |
Primary outcome
Questionaire to determine the satisfaction of the use of the GenXpert
Time frame: 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
1 secondary outcome
The detection of HCV RNA
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening: HCV RNA test and risk factors questionaire in people with Drug Use and Hepatitis C, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geert Robaeys, prof. dr. (+32 89 32 65 05, geert.robaeys@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionaire to determine the satisfaction of the use of the GenXpert (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.