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

NCT03939013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2021-02-02

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Xpert HCV VL

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

Sponsors & Collaborators

  • Myanmar Liver Foundation

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    collaborator OTHER

  • UNITAID

    collaborator OTHER

  • Macfarlane Burnet Institute for Medical Research and Public Health Ltd

    lead OTHER

Principal Investigators

  • Margaret Hellard · Burnet Institute

  • Hla Htay · Burnet Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2020-08-31
Completion
2020-12-20

Countries

  • Burma

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03939013 on ClinicalTrials.gov