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