Hepatitis C
Conditions
Keywords
Hepatitis C Virus
Brief summary
The study hypothesis is that the test and treat model utilizing video-based patient education will have higher rates of hepatitis C virus (HCV) treatment initiation and treatment completion.
Detailed description
Viral hepatitis C (HCV) represents a major public health concern and is associated with significant morbidity and mortality. HCV screening and treatment among people who use drugs is challenging due to barriers leading to loss within HCV care cascades at most centers providing addiction care. One critical element that would improve access to HCV therapy would be a test, educate and treat system, where people obtain drug on the same day as they are confirmed as Hepatitis C viremic.
Interventions
DIAGNOSTIC_TESTCepheid POC HCV Viremia (RNA) test
The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is a test designed for the quantitation (amount) of Hepatitis C Virus (HCV) DNA in human whole blood. The HCV RNA result will be compared to standardized laboratory assessment for HCV Viremia. The Cepheid test is for being conducted for research use only and will not be used for HCV diagnosis or treatment decisions.
OTHERHCV education from a health care provider
HCV education provided by health care provider. HCV Education will include HCV disease overview, HCV screening, treatment with G/P, and post treatment assessment and management
G/P will be provided for 8 weeks.
Sponsors
Weill Medical College of Cornell University
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open label, phase 4 randomized trial to assess test and treat strategy with simplified video-based patient education versus standard of care referral with health care provider delivered patient education.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women age greater or equal to18 at study entry or emancipated minors over greater or equal to 16 to less or equal 70 years at study entry * HCV antibody positive * HCV treatment naïve (no prior treatment with an approved or investigational anti HCV medication)
Exclusion criteria
* Current or history of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry * History of hepatocellular carcinoma (HCC) * Any history of active Hepatitis B or positive HBsAg positive test * HCV RNA undetectable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects who initiated treatment within 8-week window from enrollment. | Up to 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects who complete treatment in 8 weeks | Up to 8 weeks |
| Sustained Viral Response 12 weeks post dosing (SVR12) (<lower limit of quantification (LLOQ) of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment) | Up to 24 weeks |
| SVR12 (<LLOQ of HCV RNA in at 12 weeks post treatment with window up to 24 weeks after end of treatment) from real world evidence post-marketing observational study (RWE PMOS) efficacy G/P9 (compare test and treat arm with PMOS SVR12 result) | Up to 24 weeks |
Countries
United States
Outcome results
None listed