Image: (L-R) Dr Win Aung, Professor Margaret Hellard, President (MLF) Professor Khin Pyone Kyi, Dr Yi Yi Sein, Dr Mu Mya at Than Sitt Charity Clinic

The CT2 Study is an effectiveness-implementation hybrid trial assessing the feasibility, acceptability, effectiveness and cost-effectiveness of a community-based testing and treatment program for hepatitis C (HCV).

Image: A laboratory assistant taking blood

Objectives

The two broad aims of the CT2 study are:

1. To determine the feasibility, effectiveness, acceptability and cost-effectiveness of a de-centralised approach to hepatitis C testing in people at high risk of hepatitis C in two different populations attending community-based clinics in Yangon and Mandalay, Myanmar.

2. To determine the feasibility, effectiveness, acceptability and cost effectiveness of a de-centralised approach to hepatitis C treatment using direct-acting antivirals (DAAs), with support from specialist liver services, in patients testing HCV RNA positive in two community-based clinics in Yangon and Mandalay, Myanmar.

Study design

This is an effectiveness-implementation hybrid trial. There are two study sites:

1. Thingangyun Key Population Service Centre (Burnet Institute, serving people who inject drugs primarily), No.63B, Ground Floor, Yadanar Thukha Street, Thingangyun Township, Yangon

2. Than Sitt Charity Liver Clinic – 1 Yangon (Myanmar Liver Foundation, serving general population), No.33-35, Ground Floor, Pathein Street, Sanchaung Township, Yangon

This study is funded by the Foundation of Innovative New Diagnostics (FIND).

Study inclusion criteria:

• Aged ≥18 years

• Attendance at study site

• Willing and able to provide written informed consent

Study exclusion criteria:

• Confirmed HCV RNA positive result (chronic HCV infection) prior to study recruitment

• Treatment experienced (either DAA or pegylated interferon)

• HBV infected

• HIV infected

• eGFR <30

• Active tuberculosis (if known active tuberculosis or as per symptom screening assessment)

• Pregnant women

• Serious drug-drug interaction with sofosbuvir/daclatasvir, or a drug that the patient is unwilling or unable to stop taking

Patients with confirmed HCV RNA positive results will receive standard of care in Myanmar. This will involve receiving services provided through the government testing and treatment program or through philanthropic services providing testing and treatment.

Ethical considerations

The study protocol, site-specific informed consent forms, recruitment materials, as well as any subsequent modifications, are approved by Department of Medical Research Institutional Review Board in Myanmar and Alfred Ethics Committee in Melbourne.

Written informed consent is obtained from every study participant.

Publication

The results will be submitted for publication in peer-reviewed journals and abstracts submitted for relevant conference presentations. No identifying information from study participants will be included in any publications, reports or presentations. Results presented will only contain aggregate data.

Results

The results of this study will inform any potential scale-up of community-based primary care provision of hepatitis C services in Myanmar and other resource-constrained settings. Preliminary results of the first 250 participants recruited were presented at INHSU Conference in September 2019 with poster available online.

Image: A counselor chats with clients outside the Burnet Institute Thingangyun Clinic

Timeline

• January 2019 – September 2020

Outcomes

• The findings of CT2 were presented at the INHSU 2019 and APASL 2020 conferences.
• CT2 study protocol paper has been accepted for publication at the peer-review journal JMIR.