Hepatitis C VirusParcoursVHCNCT02893046
HCV Care Pathway in Ile-de-France
An observational study of Hepatitis C Virus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Sep 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients newly screened positive for HCV among private practitioners, screening and diagnostic centers, precarious consultations addictology structures, associations of patients or medical units detention centers. Patients already diagnosed positive for HCV but not monitored in a care sector will also be included in the pathway
Who may be able to join
- 18 years old and more
- Positive Hepatitis C virus
- Patient having expressed a non-objection to participate in this research
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.
Read the detailed description
The current estimation of infected persons with chronic hepatitis C in France is over 200 ,000. It appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. Indeed, these new HCV infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (MSM) and who are supported too late and without real access to treatment.
- Conditions
- Hepatitis C Virus
- Being tested
- No intervention
- Keywords
- care pathway, hospital- private network, early consultation
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Population at Risk | Population with at least one risk factor of being infected with hepatitis C; MSM population; people in precarious situations and / or attending support from addictions care structures. Receives: Other: No intervention | |
| Prison population | Proposal of participation to a " consultation arrivants " by the staff of medical units correctional Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients effectively cared divided by number of patients eligible to care.
Measured: Year 3
Secondary outcomes (3)
Number of patients cared in the HCV care pathway in Ile-de-France
Measured: Year 3
Number of patients effectively treated divided by number of patients eligible to DAA treatment.
Measured: Year 3
Delay between HCV diagnosis and early consultation
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Responsible party
- Sponsor
- Investigators
- Stéphanie DOMINGUEZ, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893046
- Sponsor's protocol ID
- RARS 28
- Acronym
- ParcoursVHC
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HCV Care Pathway in Ile-de-France
- ClinicalTrials.gov ID
- NCT02893046
- Acronym / sponsor ID
- ParcoursVHC / RARS 28
- Conditions
- Hepatitis C Virus
- Keywords
- care pathway, hospital- private network, early consultation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence Regionale de Sante d'Ile de France
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- 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 main objective of this research is to evaluate a care pathway adapted to different category populations at risk of being infected with the hepatitis C virus in order to improve both the diagnosis turnaround times and the access to treatment. The aim is to allow a quick and effective access to diagnosis and treatment of HCV by strengthening the city hospital networks, access to early consultations and coordination of medical social actors.
Detailed description
The current estimation of infected persons with chronic hepatitis C in France is over 200 ,000. It appears that prevention, screening, care management, medical and social care of patients can be significantly improved especially among the most vulnerable populations. Indeed, these new HCV infections are mediated by drug-using people, prisoners, migrants, men who have sex with men (MSM) and who are supported too late and without real access to treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population at Risk | – | Other: No interventionPopulation with at least one risk factor of being infected with hepatitis C; MSM population; people in precarious situations and / or attending support from addictions care structures. |
| Prison population | – | Other: No interventionProposal of participation to a " consultation arrivants " by the staff of medical units correctional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly screened positive for HCV among private practitioners, screening and diagnostic centers, precarious consultations addictology structures, associations of patients or medical units detention centers. Patients already diagnosed positive for HCV but not monitored in a care sector will also be included in the pathway
Key inclusion criteria (3 listed)
- 18 years old and more
- Positive Hepatitis C virus
- Patient having expressed a non-objection to participate in this research
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| No intervention | Other | Population at Risk, Prison population |
Primary outcome
Number of patients effectively cared divided by number of patients eligible to care.
Time frame: Year 3
3 secondary outcomes
Number of patients cared in the HCV care pathway in Ile-de-France
Time frame: Year 3
Number of patients effectively treated divided by number of patients eligible to DAA treatment.
Time frame: Year 3
Delay between HCV diagnosis and early consultation
Time frame: Year 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
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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.
Stéphanie DOMINGUEZ, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 0 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 8 Sep 2016. 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 France. 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 Stéphanie DOMINGUEZ, MD ((0)1 49 81 25 26 ext. +33, stephanie.dominguez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients effectively cared divided by number of patients eligible to care. (time frame: Year 3). 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 8 Sep 2016.