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Donate today to support women in science at Burnet and their work to unlock the vaginal microbiome and reduce risk of HIV infection and preterm birth for women around the world.
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 a feasibility study 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
This study aims to assess the feasibility, acceptability, effectiveness, and cost-effectiveness of decentralized community-based POC testing and DAA therapy for hepatitis C among people who inject drugs and the general population in Yangon, Myanmar.
Study design
This is a feasibility study with two sites:
Thingangyun Key Population Service Centre (Burnet Institute, serving people who inject drugs primarily), No.63B, Ground Floor, Yadanar Thukha Street, Thingangyun Township, Yangon
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.
Results from the CT2 Study were presented at the EASL ILC Virtual Event in August 2020. The summary findings were presented to key stakeholders at the dissemination workshop in October 2020. The Summary Report is now available online on this page.
Read the protocol paper.
Image: A counselor chats with clients outside the Burnet Institute Thingangyun Clinic
For any general enquiries relating to this project, please contact:
Deputy Director, Programs; Adjunct Professor, Monash University, DEPM.