Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar) (CT2)
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|ClinicalTrials.gov Identifier: NCT03939013|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Diagnostic Test: Xpert HCV VL||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||450 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)|
|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|
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
- 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).
- 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).
- 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).
- 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).
- 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).
- 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.
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
|Contact: Margaret Hellard, MBBS, PhDemail@example.com|
|Contact: Burnet Institute|
|Myanmar Liver Foundation Than Sitt Charity Clinic||Recruiting|
|Contact: Khin Pyone Kyi +959-964482820 firstname.lastname@example.org|
|Contact: Hla Htay, MBBS, MPH +95 (01) 375785 ext 404 Hla.Htay@burnet.edu.au|
|Principal Investigator:||Margaret Hellard||Burnet Institute|
|Principal Investigator:||Hla Htay||Burnet Institute|