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Completed

NCT Number: NCT03939013

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

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Myanmar Liver Foundation Than Sitt Charity Clinic, Yangon, Burma

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xpert HCV VL

Diagnostic Test

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Other

Collaborators

  • Foundation for Innovative New Diagnostics, Switzerland
  • Myanmar Liver Foundation
  • UNITAID

Registry information

Acronym: CT2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 6, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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