Hepatitis CNCT02971488
The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID
An observational study of Hepatitis C and Drug Users, run by Hospital Universitario Infanta Leonor.
Trial summary
Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Drug Users, Harm Reduction
- What is being tested?
- Screening for HCV in PWID and Linkage-To-Care
- How many people
- 529 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2017to 10 May 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. It is estimated that between 4000 and 6000 people per day visit the shantytown for their dose. The regional government's Anti-Drug Agency has a mobile HRU operating daily in the area. The unit provides screening tests to anyone who is willing to take them, regardless of whether they are already aware of their serological status or not. Screening includes education on prevention of HCV infection and other transmissible diseases.
Who may be able to join
- PWID
- >18 years of age
- Signed consent form
Who cannot join
None listed.
About this study
Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.
- Conditions
- Hepatitis C, Drug Users, Harm Reduction, HIV
- Being tested
- Screening for HCV in PWID and Linkage-To-Care
- Keywords
- Hepatitis C, PWID, Linkage-to-care
- Medical subject headings
- Hepatitis C, Drug Misuse, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for HCV in PWID and Linkage-To-CareOther
Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy.
Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population.
| Study group | Role | What they receive |
|---|---|---|
| Persons who inject drugs (PWID) | The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. Receives: Other: Screening for HCV in PWID and Linkage-To-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to
Percentage of participants who had a positive HCV test and results of the test was delivered to them.
Measured: 2 years
Percentage of Participants Who Were Evaluated at a HCV Clinic.
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Measured: 2 years
Percentage of Participants Who Started HCV Antiviral Therapy.
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Measured: 2 years
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Measured: 2 years
Secondary outcomes (2)
Percentage of Participants With Active HCV in Screened Population
Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.
Measured: 2 years
Prevalence of Other Chronic Viral Infections in the Population Screened
Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start15 Jan 2017
- Primary completion31 Dec 2018
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 529 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Leonor
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacion SEIMC-GESIDA
- Responsible party
- Principal investigator, Pablo Ryan, Hospital Universitario Infanta Leonor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971488
- Sponsor's protocol ID
- HUIL 15/03
- Status last verified
- Aug 2019
- First submitted
- 13 Oct 2016
- Last updated
- 13 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: not shared in public
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Linkage-to-care of an Alternative Hepatitis C Screening Method in PWID
- ClinicalTrials.gov ID
- NCT02971488
- Acronym / sponsor ID
- HUIL 15/03
- Conditions
- Hepatitis C, Drug Users, Harm Reduction, HIV
- Keywords
- Hepatitis C, PWID, Linkage-to-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Hospital Universitario Infanta LeonorUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundacion SEIMC-GESIDA
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Posted 13 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screening, diagnosis and treatment of HCV in PWID, should be part of a harm reduction strategy. Treatment of HCV infected PWID should be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. More frequent diagnosis, new methods that prevent loss of tracking, and access to antiviral treatment are all strategies that must be implemented jointly if the prevalence of HCV infection in our setting is to be reduced.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons who inject drugs (PWID) | – | Other: Screening for HCV in PWID and Linkage-To-CareThe study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises persons who visit the Cañada Real Galiana shantytown on the outskirts of Madrid, where 90% of illegal drugs in the region are sold and consumed. It is estimated that between 4000 and 6000 people per day visit the shantytown for their dose. The regional government's Anti-Drug Agency has a mobile HRU operating daily in the area. The unit provides screening tests to anyone who is willing to take them, regardless of whether they are already aware of their serological status or not. Screening includes education on prevention of HCV infection and other transmissible diseases.
Key inclusion criteria (3 listed)
- PWID
- >18 years of age
- Signed consent form
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 |
|---|---|---|
| Screening for HCV in PWID and Linkage-To-CareScreening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy. Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population. | Other | Persons who inject drugs (PWID) |
Primary outcome
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to
Time frame: 2 years
Percentage of participants who had a positive HCV test and results of the test was delivered to them.
Percentage of Participants Who Were Evaluated at a HCV Clinic.
Time frame: 2 years
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Percentage of Participants Who Started HCV Antiviral Therapy.
Time frame: 2 years
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
Percentage of Participants Who Achieved a Sustained Virological Response (SVR)
Time frame: 2 years
Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).
2 secondary outcomes
Percentage of Participants With Active HCV in Screened Population
Time frame: 2 years
Prevalence of Other Chronic Viral Infections in the Population Screened
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. not shared in public
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Drug Users, run by Hospital Universitario Infanta Leonor.
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: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to (time frame: 2 years). The study lists 4 primary outcomes in all. 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 13 Sep 2019.