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

NCT03939013 | Completed

• 1 other identifier: CT2/Alfred244-17/DMR2018-144
• Study Type: interventional
• Target: 634
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Hepatitis C

Keywords

hepatitis C; Myanmar; primary care; direct acting antivirals

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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).

  9-18 months

Secondary Outcomes (2)

• Satisfaction of testing and treatment pathway among patients

  6-18 months

• Costing of testing and treatment pathway at community site

  6-18 months

Study Arms (1)

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

Diagnostic Test: Xpert HCV VL

Interventions

Xpert HCV VL DIAGNOSTIC_TEST

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

Also known as: Cepheid GeneXpert, Xpert HCV RNA

Xpert HCV VL, sof/dac (local standard of care therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Attendance at study site
• Willing and able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• Myanmar Liver Foundation: collaborator
• Foundation for Innovative New Diagnostics, Switzerland: collaborator
• UNITAID: collaborator

Study Sites (2)

Myanmar Liver Foundation Than Sitt Charity Clinic

Yangon, Burma

Location

Thingangyun Clinic

Yangon, Burma

Location

Related Publications (1)

• Draper 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.

  PMID: 35504640 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Margaret Hellard

  Burnet Institute

  PRINCIPAL INVESTIGATOR

• Hla Htay

  Burnet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Access to point-of-care hepatitis C testing in community setting to facilitate hepatitis C treatment.

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 6, 2019
• Study Start: January 30, 2019
• Primary Completion: August 31, 2020
• Study Completion: December 20, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)