NCT04113629

Simplified Monitoring Myanmar SM2 Study

Evaluation of Simplified HCV Diagnostics in HIV/HCV Co-infected Patients in Myanmar (Simplified Monitoring Myanmar SM2 Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12) following a course of DAA therapy delivered using a simplified schedule of safety and virological monitoring.

Detailed description

A total of 200 HIV/HCV co-infected patients who plan to commence DAA therapy at Specialist Hospital Waibargi and Mingaladon, will be enrolled by simple random sampling. In addition to standard of care medical procedures, each participant will complete a questionnaire and have blood taken for standard HCV RNA testing. They will also have a finger-stick capillary blood sample collected for a HCV point of care test, using the the Xpert HCV Assay performed in the GeneXpert point of care machine. Dried blood spot collection (DBS) for HCV core antigen and HCV RNA testing will be collected as a research sample. Concordance between standard of care method and new DBS method will be evaluated. The proportion of patients reaching SVR will be calculated.

Conditions

• Hepatitis C
• Liver Cirrhoses
• Liver Inflammation
• HIV Infections

Interventions

Type	Name	Description
DEVICE	HCV point of care machine	Xpert HCV Assay performed on the GeneXpert point of care machine

Timeline

• Start date: 2019-01-22
• Primary completion: 2020-12-22
• Completion: 2020-12-22
• First posted: 2019-10-03
• Last updated: 2021-02-21

Locations

1 site across 1 country: Australia