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The purpose of this study is to learn more about what psychological and social factors affect people in how they take their hepatitis C medications.
The goal of this study is to determine if a qualitative survey that assesses a patient's readiness for treatment of Hepatitis C (HCV) and associated interventions based on identified barriers can improve treatment adherence and outcomes. HCV remains a leading cause of liver cancer and end stage liver disease despite greater than 90% cure rates with new, all-oral antiviral medications. While these new medications are easier to tolerate and access than previous treatment regimens, medication adherence still remains a great barrier to cure. In this study, we will administer the Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool, a free, online survey developed at the Mount Sinai School of Medicine to determine psychosocial readiness for treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREP-C | Active Comparator | The research assistant will complete the abbreviated PREP-C survey with the study participants either before or after their medical appointment. The PREP-C tool is accessed online at https://prepc.org/. |
|
| Standard of care | No Intervention | Participants will receive the standard of care (usual care) for chronic HCV infection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREP-C | Behavioral | The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants keeping follow-up appointments | Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews. | At 4 months |
| Number of participants keeping follow-up appointments | Adherence to HCV treatment will be measured by documenting the number of participants keeping their follow-up appointments. This data will be collected from chart reviews. | At 8 months |
| Number of participants refilling medications | Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews. | At 4 months |
| Number of participants refilling medications | Adherence to HCV treatment will be measured by documenting the number of participants who refill their medications. This data will be collected from chart reviews. | At 8 months |
| Number of participants who keep lab visits | Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews. | At 4 months |
| Number of participants who keep lab visits | Adherence to HCV treatment will be measured by documenting the number of participants who keep their lab visits.This data will be collected from chart reviews. | At 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley Miller, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Liver Clinic | Atlanta | Georgia | 30303 | United States |
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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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| Rapid virologic response (RVR) | The treatment outcome will be measured by analyzing the rapid virologic response (RVR) at 4 weeks after completion of treatment. Rapid virologic response (RVR) is defined as an undetectable serum hepatitis C virus (HCV) RNA. This data will be collected from chart reviews. | At 4 weeks |
| Sustained virologic response (SVR) | The treatment outcome will be measured by analyzing the sustained virologic response (SVR) at 12 weeks after completion of treatment. SVR is defined as aviremia 12 weeks after completion of antiviral therapy. This data will be collected from chart reviews. | At 12 weeks |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |