Hepatitis CNCT02755402
Accelerated Pre-treatment Evaluation for HCV Infected Persons Who Inject Drugs
A study testing Xpert HCV Viral load and Transient elastography in people with Hepatitis C and Intravenous Drug Users, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population. The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Intravenous Drug Users
- What is being tested?
- Xpert HCV Viral load and Transient elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to May 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Person who inject drugs, defined as having injected in the past year
- Able to give an informed consent
- Unknown treatment eligibility status
Who cannot join
- Patients actively engaged in HCV follow up
- Patients visibly intoxicated at initial study visit
- Pregnant or breastfeeding women
- Pacemaker.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3J4
About this study
Official title: Impact of an Accelerated Pre-treatment Evaluation on Linkage-to-care and Linkage-to-treatment for HCV Infected Persons Who Inject Drugs
Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population.
The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly.
Read more
By using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit.
The aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.
Read the detailed description
This is a non-randomized, open-label study that aims to include HCV-infected patients who inject drugs and who do not know their treatment eligibility status. A total of 200 patients will be evaluated using our rapid evaluation protocol, which will include basic blood tests, viral load measurement using Cepheid's Xpert® HCV Viral Load technique (which will be controlled at the same time by COBAS® AmpliPrep/ COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche), available at the CHUM and approved by Health Canada), a liver fibrosis assessment and HCV genotyping. The results of the basic tests, viral load tests and FibroScan® test will be available on the same day as the patient's visit and will allow the investigator to determine straightaway whether or not the patient is treatable based on the RAMQ's reimbursement criteria at the time of the study.
If the patient is treatable, once the genotype result has been obtained, the most appropriate treatment for their medical condition, degree of liver fibrosis and genotype will be prescribed. There will be no other visits between the initial visit and the treatment initiation visit. The patient will be given an appointment for the treatment initiation visit once the medication has been approved by the RAMQ or the patient's private insurer. The patient will be seen again at weeks 2 and 4 of treatment, at the end of treatment (usually week 12), then 12, 24 and 36 weeks post-treatment.
If the patient is not treatable, he/she will be referred to the CHUM Addiction Medicine Clinic or the UHRESS (if HIV-coinfected status) for management, which will include longitudinal follow-up of his HCV and substance abuse. The patient will be seen again at 6 months and 1 year to determine whether or not there has been linkage-to-care, initiation of opioid substitution therapy if indicated and if the patient has reduced his injection drug use.
If an untreatable patient becomes treatable during follow-up, treatment will be offered.
At the same time, we will review the records of patients seen at the CHUM Addiction Medicine Clinic between October 2014 and June 2016 who meet the inclusion criteria for the study cohort and the RAMQ's treatment eligibility criteria. This cohort will be used as an historical cohort to determine the rate of linkage to treatment with the standard pre-treatment evaluation protocol.
- Conditions
- Hepatitis C, Intravenous Drug Users
- Being tested
- Xpert HCV Viral load, Transient elastography
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert HCV Viral loadDevice
HCV viral load testing
Transient elastographyDevice
Evaluation of liver fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Rapid evaluation | Experimental | Transient elastography, Xpert HCV Viral load, medical and nurse visits Receives: Device: Xpert HCV Viral load; Device: Transient elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who initiate treatment after first visit
Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls
Measured: 1 year
Secondary outcomes (8)
Proportion of patients who attend at least two visits in 6 months
To compare linkage-to-care proportion at one year of treated PWID with untreated PWID at one year.
Measured: 6 months
Proportion of patients who initiate opioid substitution therapy during follow-up
To compare opioid substitution therapy initiation rates at one year of treated and untreated PWID.
Measured: 6 months
Difference in number of injection between the month prior to study entry and the last month of follow-up
To compare drug use reduction during the study period of treated PWID with untreated PWID at one year.
Measured: 6 months
Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment
To compare proportion of treated patients who achieved SVR12 with historical controls treated in phase III trials.
Measured: 12 weeks post-treatment
Proportion of patients with a re-infection within six months of end-of-treatment
To evaluate rapid re-infection rates (<6 months) of patients who achieve end-of-treatment undetectability.
Measured: 6 months post-treatment
Difference in HCV viral load results between techniques
To compare Xpert HCV Viral Load® (Cepheid) viral loads results to HCV RealTime® (Abbott) results.
Measured: At enrollment
Recontact of initially untreatable patients
To determine the proportion of patients who change from untreatable to treatable that can be successfully recontacted and linked to care among patients initially classified as untreatable
Measured: 1 year
Treatment of initially untreatable patients
To determine the proportion of patients who will initiate HCV treatment among those who were initially classified as untreable.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2019
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Cepheid
- Responsible party
- Principal investigator, Valérie Martel-Laferrière, Centre hospitalier de l'Université de Montréal (CHUM)
- Investigators
- Valérie Martel-Laferrière, MD, MSc, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755402
- Sponsor's protocol ID
- IN-CA-337-2100
- Status last verified
- Jul 2021
- First submitted
- 20 Apr 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
Publications
Martel-Laferriere V, Brissette S, Wartelle-Bladou C, Juteau LC, Popa M, Goyer ME, Bruneau J. Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs. Subst Abuse. 2022 Aug 12;16:11782218221119068. doi: 10.1177/11782218221119068. eCollection 2022.
PubMed 35990750
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Accelerated Pre-treatment Evaluation on Linkage-to-care and Linkage-to-treatment for HCV Infected Persons Who Inject Drugs
- ClinicalTrials.gov ID
- NCT02755402
- Acronym / sponsor ID
- IN-CA-337-2100
- Conditions
- Hepatitis C, Intravenous Drug Users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Gilead Sciences, Cepheid
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 28 Apr 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.
Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population.
The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly.
By using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit.
The aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.
Detailed description
This is a non-randomized, open-label study that aims to include HCV-infected patients who inject drugs and who do not know their treatment eligibility status. A total of 200 patients will be evaluated using our rapid evaluation protocol, which will include basic blood tests, viral load measurement using Cepheid's Xpert® HCV Viral Load technique (which will be controlled at the same time by COBAS® AmpliPrep/ COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche), available at the CHUM and approved by Health Canada), a liver fibrosis assessment and HCV genotyping. The results of the basic tests, viral load tests and FibroScan® test will be available on the same day as the patient's visit and will allow the investigator to determine straightaway whether or not the patient is treatable based on the RAMQ's reimbursement criteria at the time of the study.
If the patient is treatable, once the genotype result has been obtained, the most appropriate treatment for their medical condition, degree of liver fibrosis and genotype will be prescribed. There will be no other visits between the initial visit and the treatment initiation visit. The patient will be given an appointment for the treatment initiation visit once the medication has been approved by the RAMQ or the patient's private insurer. The patient will be seen again at weeks 2 and 4 of treatment, at the end of treatment (usually week 12), then 12, 24 and 36 weeks post-treatment.
If the patient is not treatable, he/she will be referred to the CHUM Addiction Medicine Clinic or the UHRESS (if HIV-coinfected status) for management, which will include longitudinal follow-up of his HCV and substance abuse. The patient will be seen again at 6 months and 1 year to determine whether or not there has been linkage-to-care, initiation of opioid substitution therapy if indicated and if the patient has reduced his injection drug use.
If an untreatable patient becomes treatable during follow-up, treatment will be offered.
At the same time, we will review the records of patients seen at the CHUM Addiction Medicine Clinic between October 2014 and June 2016 who meet the inclusion criteria for the study cohort and the RAMQ's treatment eligibility criteria. This cohort will be used as an historical cohort to determine the rate of linkage to treatment with the standard pre-treatment evaluation protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapid evaluation | Experimental | Device: Xpert HCV Viral load, Device: Transient elastographyTransient elastography, Xpert HCV Viral load, medical and nurse visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Person who inject drugs, defined as having injected in the past year
- Able to give an informed consent
- Unknown treatment eligibility status
Key exclusion criteria (4 listed)
- Patients actively engaged in HCV follow up
- Patients visibly intoxicated at initial study visit
- Pregnant or breastfeeding women
- Pacemaker.
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 |
|---|---|---|
| Xpert HCV Viral loadHCV viral load testing | Device | Rapid evaluation |
| Transient elastographyEvaluation of liver fibrosis | Device | Rapid evaluation |
Primary outcome
Proportion of patients who initiate treatment after first visit
Time frame: 1 year
Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls
8 secondary outcomes
Proportion of patients who attend at least two visits in 6 months
Time frame: 6 months
Proportion of patients who initiate opioid substitution therapy during follow-up
Time frame: 6 months
Difference in number of injection between the month prior to study entry and the last month of follow-up
Time frame: 6 months
Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment
Time frame: 12 weeks post-treatment
Proportion of patients with a re-infection within six months of end-of-treatment
Time frame: 6 months post-treatment
Difference in HCV viral load results between techniques
Time frame: At enrollment
Recontact of initially untreatable patients
Time frame: 1 year
Treatment of initially untreatable patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 35990750Martel-Laferriere V, Brissette S, Wartelle-Bladou C, Juteau LC, Popa M, Goyer ME, Bruneau J. Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs. Subst Abuse. 2022 Aug 12;16:11782218221119068. doi: 10.1177/11782218221119068. eCollection 2022.
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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.
Valérie Martel-Laferrière, MD, MSc principal investigator
CRCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert HCV Viral load and Transient elastography in people with Hepatitis C and Intravenous Drug Users, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 27 Jul 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who initiate treatment after first visit (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755402, which also lists 1 linked publication.
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 27 Jul 2021.