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DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) (DRIVE-C)

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ClinicalTrials.gov Identifier: NCT03537196
Recruitment Status : Enrolling by invitation
First Posted : May 25, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date November 14, 2018
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
Proportion of all patients in success of the model of care [ Time Frame: Week 48 ]
Proportion of patients with HCV RNA < 15 IU/mL at the end of the study among patients who have signed the informed consent.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03537196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • Proportion of patients with detectable HCV RNA [ Time Frame: Screening pre-inclusion ]
    Proportion of patients with HCV RNA > 15 IU/mL among those with positive HCV Ab
  • Proportion of patients enrolled in care [ Time Frame: Pre-inclusion visit ]
    Proportion of patients with HCV RNA > 15 IU/mL who attended the pre inclusion visit at HCV clinic among those with hepatitis C infection;
  • Proportion of patients initiating DAA treatment [ Time Frame: Initiation treatment visit ]
    Proportion of patients who initiate the treatment among patients enrolled in care and eligible for treatment
  • Proportion of patients cured [ Time Frame: Week 24 ]
    Number of patients with HCV RNA < 15 IU/mL among those initiating the treatment eligible
  • Rate of reinfection [ Time Frame: Week 48 ]
    Number of patients with HCV RNA ≥ 15 IU/mL at the end of the study among cured patients
  • Rate of mortality [ Time Frame: Week 48 ]
    Rate of deaths among all participants with hepatitis C infection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)
Official Title  ICMJE Towards HCV Elimination: Evaluation of an Integrated Model of HCV Care Targeting People Who Inject Drugs in Hai Phong, Vietnam
Brief Summary The study aims to assess the effectiveness of a model of hepatitis C screening and integrated care, targeting people who inject drugs (PWIDs) in Hai Phong, Vietnam. In a wider perspective, this model linked to mass screening through repeated Respondent Driven Sampling (RDS) surveys, to simplified treatment protocol, and to large community-based support to improve referral to care, retention in care, adherence to treatment and prevention of reinfection, may have the potential to eliminate HCV among PWIDs in this city.
Detailed Description

Objectives :

The primary objective of this study is to assess the effectiveness of a model of hepatitis C screening and integrated care targeting PWIDs in Hai Phong, Vietnam.

This model will encompass all steps involved in achieving HCV cure among PWIDs:

i) Mass detection of hepatitis C infection among PWIDs: in the community through a large community-based Respondent Driven Sampling survey (RDS); and in HIV out-patient clinics and methadone treatment centers where serological testing should have been made, but not HCV RNA to confirm hepatitis C infection.

ii) a community-based support to improve referral to specific care for those with hepatitis C infection; iii) a HCV care system delivery integrated within the existing health system with a simplified treatment protocol taking into account PWIDs specificities such as frequent HIV co-infection and methadone treatment; iv) an optimized treatment adherence through a combination of health care therapeutic education and CBO support; v) an increase in harm reduction activities to encompass HCV risk transmission and to prevent HCV reinfection.

Secondary objectives are:

  • to assess all steps of the hepatitis C cascade of care (Hepatitis C infection diagnosis; HCV care enrolment; HCV treatment initiation; HCV treatment success);
  • to assess the occurrence of adverse events (death, morbidity) and drug-related side-effects;
  • to evaluate adherence to HCV treatment;
  • to determine factors associated with treatment failure defined by a positive HCV RNA 12 weeks after the end of HCV treatment;
  • to estimate the reinfection rate at the end of the study and to identify risk factors of HCV reinfection;
  • to project the impact and cost-effectiveness of the implemented HCV treatment intervention.

Study design : the effectiveness-implementation hybrid study type 1 design will simultaneously allow assessing the effectiveness of Direct-Acting Antivirals (DAA) care strategy among PWIDs in Vietnam, and the potential obstacles to widespread implementation.

The strategy of care includes a large community-based mass screening, a simplified treatment protocol based on a combination of DAAs, taking into account co-morbidities (addiction, HIV), physician training and important support of Community Based Organizations (CBO's) for linkage to care after screening, treatment adherence and prevention of reinfection after cure.

In addition, 2 others components are included in the study:

  • A modeling exercise to assess the impact of the intervention at the population level,
  • A cost-effectiveness analysis to further inform policy-makers.

Patients will be followed for 48 weeks after initiating HCV treatment. The estimated enrolment is 1050 participants.

Study population: people who currently inject drugs or who have recently started opioid substitution treatment.

Implementation: The study is linked to the NIDA RO1 DA041978 / ANRS 12353 DRIVE project. Participant recruitment will take place through DRIVE RDS survey and DRIVE cohort follow-up visit in two community sites managed by peer-groups in Hai Phong. All participants with positive HCV serology will be screened for hepatitis C and positive HCV RNA will be proposed for DAA treatment in 3 hospital-based HCV clinics. All participants will attend 9 study visits, comprising of clinical examination, blood collection for side effects and viral load assessment, therapeutic education, questionnaires on alcohol use, on sexual, drug use and other behaviors focusing on HCV infection risks or HCV reinfection risks and on quality of life, and harm reduction activities with the support of CBOs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
All patients with detectable HCV RNA, eligible for treatment, will receive Direct Acting Antivral drugs.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatitis C
  • Drug Use
  • Viral Hepatitis C
Intervention  ICMJE
  • Drug: Sofosbuvir 400 mg and Daclatasvir 60 mg
    All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
  • Drug: Sofosbuvir 400 mg and Daclatasvir 90 mg
    For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.
  • Drug: Ribavirin

    In case of cirrhosis:

    • Ribavirin will be added to sofosbuvir/daclatasvir during the 12 weeks of treatment. The dose will be adapted to the patient weight although the vast majority of patients (weight < 75 kg) will receive 500 mg x 2/day.
    • In case of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.
  • Drug: Sofosbuvir and Daclatasvir for 24 weeks
    In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.
Study Arms  ICMJE
  • All patients
    All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
    Intervention: Drug: Sofosbuvir 400 mg and Daclatasvir 60 mg
  • HIV/HCV co-infected patients
    For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day (sofosbuvir 400 mg and daclatasvir 90 mg)
    Intervention: Drug: Sofosbuvir 400 mg and Daclatasvir 90 mg
  • Cirrhosis
    In case of cirrhosis : ribavirin will be added to sofosbuvir / daclatasvir 12 weeks
    Intervention: Drug: Ribavirin
  • Cirrhosis with ribavirin contra-indication
    In case of cirrhosis with ribavirin contra-indication : sofosbuvir and daclatasvir for 24 weeks
    Intervention: Drug: Sofosbuvir and Daclatasvir for 24 weeks
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
1050
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

INCLUSION CRITERIA

  • Participants of the ANRS 12353/NIDA ROI DA 041978 DRIVE study (age > 18 years; positive urine test for heroin an/o methamphetamine & skin marks of injection ) who either participated to the DRIVE RDS3 survey, or to the HIV-positive and HIV-negative DRIVE cohorts;
  • Hepatitis C infection defined by a positive HCV RNA
  • Signed informed consent form

EXCLUSION CRITERIA

  • Severe associated diseases requiring specific treatment (including all specific AIDS defining illnesses, any severe sepsis, severe decompensated cirrhosis, suspicion of hepatocellular carcinoma);
  • Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study including very severe clinical condition;
  • Previous history of DAA use;
  • Contraindication for treatment with sofosbuvir or daclatasvir;
  • For women of childbearing potential i.e. women of childbearing age who are not menopausal, or permanently sterilized or not refraining from sexual activity:
  • Pregnancy and breastfeeding
  • Refusal to use a contraceptive method
  • Renal failure with creatinine clearance ≤ 30 milliliter per minute;
  • Person deprived of freedom by a judicial or administrative decision;
  • Person who plan to move out from Hai Phong in the next 12 months;
  • Person unable to understand the study;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537196
Other Study ID Numbers  ICMJE ANRS 12380 DRIVE-C
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: KHUE M. PHAM, MD, PhD Hai Phong University of Medicine and Pharmacy, Vietnam
Principal Investigator: DIDIER LAUREILLARD, MD Nîmes University Hospital, France
Study Director: NICOLAS NAGOT, MD, PhD Pathogenesis and Control of Chronic Infections (PCCI) UMR 1058 - INSERM, Univ Montpellier, EFS, Montpellier, France
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP