NCT03939013

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-30
• Primary completion: 2020-08-31
• Completion: 2020-12-20
• First posted: 2019-05-06
• Last updated: 2021-02-02

Locations

2 sites across 1 country: Burma