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

Hepatitis C Clinical Trial

— CT2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939013
• Other study ID #: CT2/Alfred244-17/DMR2018-144
• Status: Completed
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: December 20, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Myanmar	Myanmar Liver Foundation Than Sitt Charity Clinic	Yangon
Myanmar	Thingangyun Clinic	Yangon

Sponsors (4)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	Foundation for Innovative New Diagnostics, Switzerland, Myanmar Liver Foundation, UNITAID

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Ab positive patients who receive GeneXpert HCV VL test	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
Primary	Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection	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
Primary	Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection	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
Primary	Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection	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	Satisfaction of testing and treatment pathway among patients	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
Secondary	Costing of testing and treatment pathway at community site	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