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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04113629

Acronym

SM2

Enrollment

200

Registered

2019-10-03

Start date

2019-01-22

Completion date

2020-12-22

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, HIV Infections, Liver Cirrhoses, Liver Inflammation

Brief 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.

Interventions

DEVICEHCV point of care machine

Xpert HCV Assay performed on the GeneXpert point of care machine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Sequential Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects must meet all of the following inclusion criteria to participate in this study. 1. Have voluntarily signed the consent form. 2. 18 years of age or older. 3. HCV antibody positive. 4. HIV antibody positive.

Exclusion criteria

Subjects who meet any of the

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)	12 weeks post completion of commenced treatment	To 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026