Drug UseICONENCT04008927
A Community-based Intervention Among Active Drug Users in Montpellier
A study testing HCV screening, Diagnosis of hepatitis C and HCV treatment in people with Drug Use and HCV Infection, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France. 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, HCV Infection
- What is being tested?
- HCV screening, Diagnosis of hepatitis C and HCV treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2020to 10 Sep 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
- Age> 18 years
- Be an active drug user defined by:
- Report current and regular (Last uptake no more than 3 days ago and at least 10 times a month) use of illicit psychoactive substances other than cannabis (heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or misused medications (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine) AND
- Positive urine test for a psychoactive substance other than cannabis (Heroin, amphetamines, cocaine, MDMA/ecstasy, cathinones) or a misused medication (methadone, buprenorphine, opiate drugs, methylphenidate, ketamine).
Who cannot join
- Inability to understand the study
- Be under guardianship, curatorship or future protection mandate
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.
The study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.
Read the detailed description
Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey
Secondary objectives of the research are:
- To estimate the seroprevalence of hepatitis C in active DUs in Montpellier;
- To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method;
- To estimate HCV care cascade steps in active DUs in Montpellier;
- To identify the factors associated with HCV treatment failure;
- To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment;
- To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.
- Conditions
- Drug Use, HCV Infection
- Being tested
- HCV screening, Diagnosis of hepatitis C, HCV treatment
- Keywords
- Hepatitis C, RDS survey, Communauty-based intervention, Viral hepatitis C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCV screeningDiagnostic test
All patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services.
Diagnosis of hepatitis CDiagnostic test
HCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL). In addition a measure of the liver stiffness will be performed.
HCV treatmentDrug
Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | All participants recruited during the RDS survey. Receives: Diagnostic Test: HCV screening |
| HCV infected patients | Other | HCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL) Receives: Diagnostic Test: Diagnosis of hepatitis C |
| Patients with hepatitis C | Other | Patients diagnosed with chronic hepatitis C will be prescribed with DAA treatment on research site. After one month they will be referred to conventional health structure for treatment follow-up. Receives: Drug: HCV treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of treated and cured DU participants.
Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion.
Measured: SVR12 (12 weeks after end of HCV treatment)
Secondary outcomes (7)
Proportion of participants with a HCV positive serology
Proportion of participants with a HCV positive serology among all participants
Measured: Screening RDS
Estimated number of drug users in the city of Montpellier
Estimated number of drug users in the city of Montpellier by capture/recapture survey
Measured: Screening RDS
Proportion of participants with detectable HCV-RNA
Proportion of patients with HCV RNA > 10 IU/mL among those with positive HCV serology
Measured: Screening RDS
Proportion of participants initiating anti-viral treatment
Proportion of patients with chronic hepatitis who initiate the treatment among patients with HCV-RNA >10 UI/mL
Measured: Day 0
Rate of reinfection
Proportion of cured participants re-infected within months after end of treatment defined by positive HCV-RNA of different genotype at SVR12 or by positive HCV-RNA at W44/48
Measured: Week 48
Hepatitis B infection rate
Proportion of participants with HBs antigene and positive B-DNA at baseline
Measured: Screening RDS
HIV infection rate and ART coverage
Proportion of participants with positive HIV serology at baseline and proportion of participants with anti-viral treatment among HIV positive participants at baseline
Measured: Screening RDS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start18 Sep 2020
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Effectiveness-implementation hybrid study type 2. This study design will simultaneously allow assessing the effectiveness of the model, using the percentage of HCV cure as criteria, and the feasibility by measuring potential obstacles during implementation.
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- HELENE DONNADIEU-RIGOLE, MD, PhD, Principal investigator, CHU Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008927
- Sponsor's protocol ID
- ANRS 95050 ICONE
- Acronym
- ICONE
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2019
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blackburn NA, Patel RC, Zibbell JE. Improving Screening Methods for Hepatitis C Among People Who Inject Drugs: Findings from the HepTLC Initiative, 2012-2014. Public Health Rep. 2016 May-Jun;131 Suppl 2(Suppl 2):91-7. doi: 10.1177/00333549161310S214.
PubMed 27168667Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, Hezode C, Pawlotsky JM. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect. 2016 May;22(5):459.e1-6. doi: 10.1016/j.cmi.2016.01.009. Epub 2016 Jan 22.
PubMed 26806260Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
PubMed 22310560Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.
PubMed 29432973Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.
PubMed 27178119Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9.
PubMed 27537841Leon L, Kasereka S, Barin F, Larsen C, Weill-Barillet L, Pascal X, Chevaliez S, Pillonel J, Jauffret-Roustide M, LE Strat Y. Age- and time-dependent prevalence and incidence of hepatitis C virus infection in drug users in France, 2004-2011: model-based estimation from two national cross-sectional serosurveys. Epidemiol Infect. 2017 Apr;145(5):895-907. doi: 10.1017/S0950268816002934. Epub 2016 Dec 22.
PubMed 28004616Nagot N, D'Ottavi M, Quillet C, Debellefontaine A, Castellani J, Langendorfer N, Hanslik B, Guichard S, Baglioni R, Faucherre V, Tuaillon E, Pageaux GP, Laureillard D, Donnadieu-Rigole H. Reaching Hard-to-Reach People Who Use Drugs: A Community-Based Strategy for the Elimination of Hepatitis C. Open Forum Infect Dis. 2022 Apr 14;9(6):ofac181. doi: 10.1093/ofid/ofac181. eCollection 2022 Jun.
PubMed 35774932
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Ending HCV Infection Among Active Drug Users: a Community-based Intervention in Montpellier.
- ClinicalTrials.gov ID
- NCT04008927
- Acronym / sponsor ID
- ICONE / ANRS 95050 ICONE
- Conditions
- Drug Use, HCV Infection
- Keywords
- Hepatitis C, RDS survey, Communauty-based intervention, Viral hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 5 Jul 2019 (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 study aims to assess the effectiveness of a community-based model of HCV mass screening associated with an immediate HCV treatment on the cascade of care among active drug users (DUs) in the city of Montpellier, France.
Detailed description
Active DUs will be recruited using a Respondent-Driven Sampling (RDS) method. Hosted in the temporary community care facility (the research site), located outside the existing care facilities in the city, participants will benefit from HCV/HIV/HBV screening, on-site measurement of HCV-RNA and liver fibrosis, early treatment, treatment follow-up and risk and harm reduction tools related to their risk practices. Peers will be present in this unique structure and will accompany participants throughout their treatment. Participants will be referred during treatment to existing care facilities but followed up in the research up to 44 to 48 weeks after initiation of treatment to assess the rate of re-infection. The number of active DUs in the population will be estimated by using a capture/recapture method nested in the RDS survey
Secondary objectives of the research are:
- To estimate the seroprevalence of hepatitis C in active DUs in Montpellier;
- To estimate the size of the active DUs population in the city of Montpellier using a capture/recapture method;
- To estimate HCV care cascade steps in active DUs in Montpellier;
- To identify the factors associated with HCV treatment failure;
- To determine the proportion of treated and cured HCV patients who re-infect within months after end of treatment;
- To estimate the seroprevalence of hepatitis B and HIV infection in active DUs in Montpellier.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Effectiveness-implementation hybrid study type 2. This study design will simultaneously allow assessing the effectiveness of the model, using the percentage of HCV cure as criteria, and the feasibility by measuring potential obstacles during implementation.
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Diagnostic Test: HCV screeningAll participants recruited during the RDS survey. |
| HCV infected patients | Other | Diagnostic Test: Diagnosis of hepatitis CHCV-RNA assay (GeneXpert, Cepheid) will be performed to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL) |
| Patients with hepatitis C | Other | Drug: HCV treatmentPatients diagnosed with chronic hepatitis C will be prescribed with DAA treatment on research site. After one month they will be referred to conventional health structure for treatment follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age> 18 years
- Be an active drug user defined by:
Key exclusion criteria (3 listed)
- Inability to understand the study
- Be under guardianship, curatorship or future protection mandate
- Lack of informed consent
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 |
|---|---|---|
| HCV screeningAll patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services. | Diagnostic test | All patients |
| Diagnosis of hepatitis CHCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL). In addition a measure of the liver stiffness will be performed. | Diagnostic test | HCV infected patients |
| HCV treatmentDirect-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment. | Drug | Patients with hepatitis C |
Primary outcome
Proportion of treated and cured DU participants.
Time frame: SVR12 (12 weeks after end of HCV treatment)
Proportion of treated and cured DU participants among those with a detectable HCV-RNA at pre-inclusion.
7 secondary outcomes
Proportion of participants with a HCV positive serology
Time frame: Screening RDS
Estimated number of drug users in the city of Montpellier
Time frame: Screening RDS
Proportion of participants with detectable HCV-RNA
Time frame: Screening RDS
Proportion of participants initiating anti-viral treatment
Time frame: Day 0
Rate of reinfection
Time frame: Week 48
Hepatitis B infection rate
Time frame: Screening RDS
HIV infection rate and ART coverage
Time frame: Screening RDS
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 22 Jul 2022.
- Background: PubMed 27168667Blackburn NA, Patel RC, Zibbell JE. Improving Screening Methods for Hepatitis C Among People Who Inject Drugs: Findings from the HepTLC Initiative, 2012-2014. Public Health Rep. 2016 May-Jun;131 Suppl 2(Suppl 2):91-7. doi: 10.1177/00333549161310S214.
- Background: PubMed 26806260Chevaliez S, Poiteau L, Rosa I, Soulier A, Roudot-Thoraval F, Laperche S, Hezode C, Pawlotsky JM. Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care. Clin Microbiol Infect. 2016 May;22(5):459.e1-6. doi: 10.1016/j.cmi.2016.01.009. Epub 2016 Jan 22.
- Background: PubMed 22310560Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
- Background: PubMed 29432973Des Jarlais D, Khue PM, Feelemyer J, Arasteh K, Thi Huong D, Thi Hai Oanh K, Thi Giang H, Thi Tuyet Thanh N, Vinh VH, Heckathorn DD, Moles JP, Vallo R, Quillet C, Rapoud D, Michel L, Laureillard D, Hammett T, Nagot N. Using dual capture/recapture studies to estimate the population size of persons who inject drugs (PWID) in the city of Hai Phong, Vietnam. Drug Alcohol Depend. 2018 Apr 1;185:106-111. doi: 10.1016/j.drugalcdep.2017.11.033. Epub 2018 Feb 2.
- Background: PubMed 27178119Des Jarlais D, Duong HT, Pham Minh K, Khuat OH, Nham TT, Arasteh K, Feelemyer J, Heckathorn DD, Peries M, Moles JP, Laureillard D, Nagot N; (The Drive Study Team). Integrated respondent-driven sampling and peer support for persons who inject drugs in Haiphong, Vietnam: a case study with implications for interventions. AIDS Care. 2016 Oct;28(10):1312-5. doi: 10.1080/09540121.2016.1178698. Epub 2016 May 13.
- Background: PubMed 27537841Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, Luetkemeyer A, Nahass R, Peng CY, Conway B, Grebely J, Howe AY, Gendrano IN, Chen E, Huang HC, Dutko FJ, Nickle DC, Nguyen BY, Wahl J, Barr E, Robertson MN, Platt HL; C-EDGE CO-STAR Study Group. Elbasvir-Grazoprevir to Treat Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy: A Randomized Trial. Ann Intern Med. 2016 Nov 1;165(9):625-634. doi: 10.7326/M16-0816. Epub 2016 Aug 9.
- Background: PubMed 28004616Leon L, Kasereka S, Barin F, Larsen C, Weill-Barillet L, Pascal X, Chevaliez S, Pillonel J, Jauffret-Roustide M, LE Strat Y. Age- and time-dependent prevalence and incidence of hepatitis C virus infection in drug users in France, 2004-2011: model-based estimation from two national cross-sectional serosurveys. Epidemiol Infect. 2017 Apr;145(5):895-907. doi: 10.1017/S0950268816002934. Epub 2016 Dec 22.
- Derived from this study: PubMed 35774932Nagot N, D'Ottavi M, Quillet C, Debellefontaine A, Castellani J, Langendorfer N, Hanslik B, Guichard S, Baglioni R, Faucherre V, Tuaillon E, Pageaux GP, Laureillard D, Donnadieu-Rigole H. Reaching Hard-to-Reach People Who Use Drugs: A Community-Based Strategy for the Elimination of Hepatitis C. Open Forum Infect Dis. 2022 Apr 14;9(6):ofac181. doi: 10.1093/ofid/ofac181. eCollection 2022 Jun.
- Combating Hepatitis B and C to reach elimination by 2030. WHO, 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
HELENE DONNADIEU-RIGOLE, MD, PhD principal investigator
CHU Montpellier, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCV screening, Diagnosis of hepatitis C and HCV treatment in people with Drug Use and HCV Infection, run by ANRS, Emerging Infectious Diseases 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 4 inclusion and 3 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 22 Jul 2022. 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?
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 treated and cured DU participants. (time frame: SVR12 (12 weeks after end of HCV treatment)). 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 NCT04008927, which also lists 8 linked publications.
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 Jul 2022.