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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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03939013
Study type Interventional
Source Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Contact
Status Completed
Phase N/A
Start date January 30, 2019
Completion date December 20, 2020

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