Hepatitis CCT2NCT03939013
Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
A study testing Xpert HCV VL in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 2 sites in Burma.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Xpert HCV VL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 2 sitesBurma
- Study dates
- 30 Jan 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Attendance at study site
- Willing and able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Burma2 sites
Myanmar Liver Foundation Than Sitt Charity Clinic
Yangon
Thingangyun Clinic
Yangon
About this study
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).
Read the 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
- Being tested
- Xpert HCV VL
- Keywords
- hepatitis C, Myanmar, primary care, direct acting antivirals
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert HCV VLDiagnostic test
Also called Cepheid GeneXpert, Xpert HCV RNA
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
| Study group | Role | What they receive |
|---|---|---|
| Xpert HCV VL, sof/dac (local standard of care therapy) | Experimental | Use of Cepheid GeneXpert HCV VL device as diagnostic tool to test for HCV RNA for diagnosis of chronic hepatitis C infection, for assessment of sustained virological response at 12 weeks post treatment completion Receives: Diagnostic Test: Xpert HCV VL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Ab positive patients who receive GeneXpert HCV VL test
Calculated by using Number of HCV Ab tests performed, Number of HCV RNA tests performed. Aggregate data is taken from patient-level case report forms recording results of tests performed (Clinical Case Report Form 1 \& 2).
Measured: 6-9 months of recruitment
Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection
Calculated by using Number of HCV RNA positive patients, Number of patients started on DAAs. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2 \& 3).
Measured: 9-12 months of recruitment & treatment
Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
Measured: 9-18 months
Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment, Number of patients who achieve SVR12 as measured by GeneXpert HCV VL not detected 12 weeks post completion of treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
Measured: 9-18 months
Secondary outcomes (2)
Satisfaction of testing and treatment pathway among patients
Measured using a patient completed survey covering domains of satisfaction with care received, any barriers to accessing care and preferences for testing and treatment as per standard of care (hospital - prior experience) vs intervention (community based - trial experience).
Measured: 6-18 months
Costing of testing and treatment pathway at community site
Measured using clinical workflow observations and costing tool; collecting data on staff time spent with patient on each phase of pathway, staff costs and consumables.
Measured: 6-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start30 Jan 2019
- Primary completion31 Aug 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Access to point-of-care hepatitis C testing in community setting to facilitate hepatitis C treatment.
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Myanmar Liver Foundation, Foundation for Innovative New Diagnostics, Switzerland, UNITAID
- Responsible party
- Sponsor
- Investigators
- Margaret Hellard, Principal investigator, Burnet InstituteHla Htay, Principal investigator, Burnet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939013
- Sponsor's protocol ID
- CT2/Alfred244-17/DMR2018-144
- Acronym
- CT2
- Status last verified
- Jan 2021
- First submitted
- 17 Apr 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Draper BL, Naing MMS, Htay H, Flynn M, Stoove M, Hellard M, Pedrana A. Assessing the Utility of Shortened Read Time of the Abbott Bioline HCV Test to Predict Viremia. J Viral Hepat. 2026 Jul;33(7):e70198. doi: 10.1111/jvh.70198.
PubMed 42304557Draper BL, Yee WL, Shilton S, Bowring A, Htay H, Nwe N, Markby J, Kyi KP, Easterbrook P, Naing W, Win TM, Aung KS, Howell J, Pedrana A, Hellard M. Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up. BMJ Open. 2022 May 3;12(5):e059639. doi: 10.1136/bmjopen-2021-059639.
PubMed 35504640
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C: Community Testing and Treatment (CT2 Study Myanmar)
- ClinicalTrials.gov ID
- NCT03939013
- Acronym / sponsor ID
- CT2 / CT2/Alfred244-17/DMR2018-144
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, Myanmar, primary care, direct acting antivirals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Macfarlane Burnet Institute for Medical Research and Public Health LtdUniversity, hospital or other
- Collaborators
- Myanmar Liver Foundation, Foundation for Innovative New Diagnostics, Switzerland, UNITAID
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Access to point-of-care hepatitis C testing in community setting to facilitate hepatitis C treatment.
| Arm | Type | Receives |
|---|---|---|
| Xpert HCV VL, sof/dac (local standard of care therapy) | Experimental | Diagnostic Test: Xpert HCV VLUse of Cepheid GeneXpert HCV VL device as diagnostic tool to test for HCV RNA for diagnosis of chronic hepatitis C infection, for assessment of sustained virological response at 12 weeks post treatment completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years
- Attendance at study site
- Willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert HCV VLAlso: Cepheid GeneXpert, Xpert HCV RNAUse 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 | Diagnostic test | Xpert HCV VL, sof/dac (local standard of care therapy) |
Primary outcome
Proportion of Ab positive patients who receive GeneXpert HCV VL test
Time frame: 6-9 months of recruitment
Calculated by using Number of HCV Ab tests performed, Number of HCV RNA tests performed. Aggregate data is taken from patient-level case report forms recording results of tests performed (Clinical Case Report Form 1 \& 2).
Proportion of RNA positive patients who receive direct-acting antiviral therapy for chronic hepatitis C infection
Time frame: 9-12 months of recruitment & treatment
Calculated by using Number of HCV RNA positive patients, Number of patients started on DAAs. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2 \& 3).
Proportion of patients who complete direct-acting antiviral therapy for chronic hepatitis C infection
Time frame: 9-18 months
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
Proportion of patients who achieve SVR12 who started on direct-acting antiviral therapy for chronic hepatitis C infection
Time frame: 9-18 months
Calculated by using Number of patients started on DAAs, Number of patients who completed treatment, Number of patients who achieve SVR12 as measured by GeneXpert HCV VL not detected 12 weeks post completion of treatment. Aggregate data is taken from patient-level case report forms recording results of tests performed and treatment plan (Clinical Case Report Form 1, 2, 3, 4 \& 5).
2 secondary outcomes
Satisfaction of testing and treatment pathway among patients
Time frame: 6-18 months
Costing of testing and treatment pathway at community site
Time frame: 6-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 42304557Draper BL, Naing MMS, Htay H, Flynn M, Stoove M, Hellard M, Pedrana A. Assessing the Utility of Shortened Read Time of the Abbott Bioline HCV Test to Predict Viremia. J Viral Hepat. 2026 Jul;33(7):e70198. doi: 10.1111/jvh.70198.
- Derived from this study: PubMed 35504640Draper BL, Yee WL, Shilton S, Bowring A, Htay H, Nwe N, Markby J, Kyi KP, Easterbrook P, Naing W, Win TM, Aung KS, Howell J, Pedrana A, Hellard M. Feasibility of decentralised, task-shifted hepatitis C testing and treatment services in urban Myanmar: implications for scale-up. BMJ Open. 2022 May 3;12(5):e059639. doi: 10.1136/bmjopen-2021-059639.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Hellard principal investigator
Burnet Institute
Hla Htay principal investigator
Burnet Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpert HCV VL in people with Hepatitis C, run by Macfarlane Burnet Institute for Medical Research and Public Health Ltd at 2 sites in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Ab positive patients who receive GeneXpert HCV VL test (time frame: 6-9 months of recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.