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

Status Completed

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

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms