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The funding was halted.
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| Name | Class |
|---|---|
| AbbVie | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV Education | Active Comparator | The intervention of HCV education will be performed at the addiction care setting for video- based patient education. Health care provide delivered patient education is the standard of care referral approach. HCV Education will include HCV disease overview, HCV screening, taking Glecaprevir/Pibrentasivir (G/P), and post study drug assessment and management. Participants may be randomized to either the video-based patient education or the HCV delivered patient education. |
|
| Point of Care (POC) HCV Viremia (RNA) testing | Experimental | All participants will have standardized laboratory assessments for HCV Viremia (RNA testing) as well as Cepheid 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 being conducted for research use only and will not be used for HCV diagnosis or treatment decisions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cepheid POC HCV Viremia (RNA) test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who initiated treatment within 8-week window from enrollment. | Up to 8 weeks |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Brown, MD, MPH | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix House | Long Island City | New York | 11101 | United States | ||
| ColumbiaDoctors Midtown |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
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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.
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| HCV education from a health care provider | Other | 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 |
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| Glecaprevir and Pibrentasvir | Drug | G/P will be provided for 8 weeks. |
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| 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 |
| New York |
| New York |
| 10019 |
| United States |
| Weill Cornell Medicine Midtown Center for Treatment and Research | New York | New York | 10036 | United States |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |