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Simplified Monitoring Myanmar SM2 Study — SM2  

HIV Infections Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04113629
Study type Interventional
Source Kirby Institute
Contact
Status Completed
Phase N/A
Start date January 22, 2019
Completion date December 22, 2020
View Details
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