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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03939013

Recruitment Status Completed

First Posted May 6, 2019

Last update posted February 2, 2021

Study Description

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:Hepatitis C
  • Intervention/Treatment: Diagnostic Test: Xpert HCV VL
  • Phase: N/A
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

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 634 participants
  • 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 2019
  • Actual Primary Completion Date: August 2020
  • Actual Study Completion Date: December 2020
Arms and interventions
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
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

Myanmar
Myanmar Liver Foundation Than Sitt Charity Clinic
Yangon

Myanmar
Thingangyun Clinic
Yangon

Sponsors and Collaborators

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Myanmar Liver Foundation

Foundation for Innovative New Diagnostics, Switzerland

UNITAID

Investigators

Principal Investigator: Margaret Hellard Burnet Institute

Principal Investigator: Hla Htay Burnet Institute

More Information
  • Responsible Party: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
  • ClinicalTrials.gov Identifier: NCT03939013 History of Changes
  • Other Study ID Numbers: CT2/Alfred244-17/DMR2018-144
  • First Posted: May 6, 2019 Key Record Dates
  • Last Update Posted: February 2, 2021
  • Last Verified: January 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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: Myanmar
    primary care
    direct acting antivirals
    hepatitis C
  • Additional relevant MeSH terms: Hepatitis A
    Hepatitis C
    Hepatitis