Platform in the use of medicines to treat hepatitis C
Not Applicable
Recruiting
- Conditions
- chronic hepatitis C infectionInfection - Other infectious diseases
- Registration Number
- ACTRN12619000023156
- Lead Sponsor
- Telethon Kids Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
To be eligible, a participant must meet the following criteria:
1. Evidence of active HCV infection (HCV RNA detected) within the preceding 3 months
2. Adult 18 years of age or above
Exclusion Criteria
A potentially eligible individual will be excluded from participation if either of the following criteria are met:
1. Already receiving direct-acting antiviral medication for HCV infection
2. Unable or unwilling to provide informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is virological cure, as evidenced by a sustained virological response (SVR) defined as a negative HCV RNA (in plasma) PCR result 6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment. [6 to 18 months after initial prescription of antiviral therapy, and no less than 12 weeks after the end of treatment]
- Secondary Outcome Measures
Name Time Method Self-reported quality of life (QoL) measured during and for up to 24 months after initiation of treatment, as measured by the EQ-5D-5L questionnaire[0, 3, 6, 12 and 24 months after initiation of therapy];Self-reported adherence of study participants to antiviral treatment (the proportion of prescribed doses taken) collected via either a weekly SMS (short message service) text message or phone message questioning the number of pills taken per week.[Weekly within the treatment period prescribed (approximately 8-12 weeks) ]