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

January 28, 2021 updated by: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

634

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Myanmar
      • Yangon, Myanmar
        • Myanmar Liver Foundation Than Sitt Charity Clinic
      • Yangon, Myanmar
        • Thingangyun Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6-9 months of recruitment
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).
9-12 months of recruitment & treatment
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).
9-18 months
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).
9-18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6-18 months
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.
6-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Collaborators

Foundation for Innovative New Diagnostics, Switzerland
UNITAID
Myanmar Liver Foundation

Investigators

  • Principal Investigator: Hla Htay, Burnet Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 30, 2019

Primary Completion (ACTUAL)

August 31, 2020

Study Completion (ACTUAL)

December 20, 2020

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

May 3, 2019

First Posted (ACTUAL)

May 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2/Alfred244-17/DMR2018-144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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