Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar) (CT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03939013
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborators:
Myanmar Liver Foundation
Foundation of Innovative and New Diagnostics
UNITAID
Information provided by (Responsible Party):
Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Brief Summary:
Implementation-effectiveness hybrid trial assessing acceptability, feasibility and cost-effectiveness of community-based point-of-care testing and treatment for hepatitis C. Utilises Cepheid GeneXpert HCV VL device as diagnostic tool (diagnosis of chronic infection and assessment of treatment outcome) and sofosbuvir/daclatasvir for HCV therapy (local standard of care).

Condition or disease Intervention/treatment Phase
Hepatitis C Diagnostic Test: Xpert HCV VL Not Applicable

Detailed Description:

Historically, testing and treatment for hepatitis C has been confined to centralised laboratories and tertiary hospitals respectively. Recent advancements in point-of-care testing for hepatitis C (anti-HCV antibody and HCV RNA/VL) and treatment options with the introduction of direct acting antivirals allows for testing and treatment to occur in de-centralised primary care settings.

This study is an effectiveness-implementation hybrid study to assess the feasibility, acceptability, effectiveness and cost-effectiveness of a de-centralised approach to hepatitis C testing and treatment at community-based clinics in Yangon, Myanmar. Generalist doctors trained in hepatitis C treatment will prescribe direct acting antiviral therapy to eligible participants.

The study will utilise SD Bioline HCV RDT and Cepheid GeneXpert HCV VL test; and sofosbuvir/daclatasvir to treat hepatitis C. Test of cure will be performed at 12 weeks post-treatment completion to assess sustained virological response (SVR).

Study inclusion criteria prior to recruitment into study:

  • Aged ≥18 years
  • Attendance at study site
  • Willing and able to provide written informed consent

Study exclusion criteria prior to recruitment into study:

  • Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
  • Treatment experienced (either DAA or pegylated interferon)
  • Hepatitis B virus (HBV) infected
  • Human Immunodeficiency Virus (HIV) infected
  • estimated glomerular filtration rate (eGFR) <30
  • Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
  • Pregnant women
  • Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Access to point-of-care hepatitis C testing in community setting to facilitate hepatitis C treatment.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Xpert HCV VL, sof/dac (local standard of care therapy)
Use of Cepheid GeneXpert HCV VL device as diagnostic tool to test for HCV RNA for diagnosis of chronic hepatitis C infection, for assessment of sustained virological response at 12 weeks post treatment completion
Diagnostic Test: Xpert HCV VL
Use of Cepheid GeneXpert HCV VL test as diagnostic tool to test for HCV RNA for diagnosis of hepatitis C infection, to test for sustained virological response at 12 weeks post treatment completion
Other Names:
  • Cepheid GeneXpert
  • Xpert HCV RNA




Primary Outcome Measures :
  1. Proportion of Ab positive patients who receive GeneXpert HCV VL test [ Time Frame: 6-9 months of recruitment ]
    Calculated by using Number of HCV Ab tests performed, Number of HCV RNA tests performed. Aggregate data is taken from patient-level case report forms recording results of tests performed (Clinical Case Report Form 1 & 2).

  2. Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection [ Time Frame: 9-12 months of recruitment & treatment ]
    Calculated by using Number of HCV RNA positive patients, Number of patients started on DAAs. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2 & 3).

  3. Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection [ Time Frame: 9-18 months ]
    Calculated by using Number of patients started on DAAs, Number of patients who completed treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 & 5).

  4. Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection [ Time Frame: 9-18 months ]
    Calculated by using Number of patients started on DAAs, Number of patients who completed treatment, Number of patients who achieve SVR12 as measured by GeneXpert HCV VL not detected 12 weeks post completion of treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 & 5).


Secondary Outcome Measures :
  1. Satisfaction of testing and treatment pathway among patients [ Time Frame: 6-18 months ]
    Measured using a patient completed survey covering domains of satisfaction with care received, any barriers to accessing care and preferences for testing and treatment as per standard of care (hospital - prior experience) vs intervention (community based - trial experience).

  2. Costing of testing and treatment pathway at community site [ Time Frame: 6-18 months ]
    Measured using clinical workflow observations and costing tool; collecting data on staff time spent with patient on each phase of pathway, staff costs and consumables.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥18 years
  • Attendance at study site
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment
  • Treatment experienced (either DAA or pegylated interferon)
  • Hepatitis B virus (HBV) infected
  • Human Immunodeficiency Virus (HIV) infected
  • estimated glomerular filtration rate (eGFR) <30
  • Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)
  • Pregnant women
  • Serious drug-drug interaction with sofosbuvir/daclatasvir of a drug that the patient is unwilling or unable to stop taking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939013


Contacts
Layout table for location contacts
Contact: Margaret Hellard, MBBS, PhD +61385062304 margaret.hellard@burnet.edu.au
Contact: Burnet Institute

Locations
Layout table for location information
Myanmar
Myanmar Liver Foundation Than Sitt Charity Clinic Recruiting
Yangon, Myanmar
Contact: Khin Pyone Kyi    +959-964482820    clinic-ygn@liverfoundationmm.org   
Thingangyun Clinic Recruiting
Yangon, Myanmar
Contact: Hla Htay, MBBS, MPH    +95 (01) 375785 ext 404    Hla.Htay@burnet.edu.au   
Sponsors and Collaborators
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Myanmar Liver Foundation
Foundation of Innovative and New Diagnostics
UNITAID
Investigators
Layout table for investigator information
Principal Investigator: Margaret Hellard Burnet Institute
Principal Investigator: Hla Htay Burnet Institute
Layout table for additonal information
Responsible Party: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
ClinicalTrials.gov Identifier: NCT03939013    
Other Study ID Numbers: CT2/Alfred244-17/DMR2018-144
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Macfarlane Burnet Institute for Medical Research and Public Health Ltd:
hepatitis C
Myanmar
primary care
direct acting antivirals
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections