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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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Up to 150 individuals with current hepatitis C (HCV) will be recruited from mobile health clinics in rural South Carolina - sites will be selected based on HCV prevalence rates and lack of current HCV screening/treatment resources. NPs will provide HCV care through mobile health units. Participants will be randomized (1:1) to either mobile health clinic treatment as usual or virtual care coordination. Virtual care coordination designed to move people along HCV care cascade will be conducted by the Emocha smartphone platform - an adaptable platform designed by emocha to link patients to care. Using quantitative methods, associations between psychosocial factors such as homelessness, mental illness, provider mistrust, poor social support, high levels of shame and stigma with HCV outcomes including SVR will be examined. Investigators hypothesize that SVR rate among the HCV-infected individuals treated (and with follow-up SVR determination) will be 90% with the Clopper-Pearson 95% CI having a width of 13%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | No Intervention | TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment | |
| Virtual Care Coordination | Experimental | Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Care Coordination | Behavioral | Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HCV Treatment Initiation Rates | To determine whether treatment initiation rates are higher among patients randomized to Emocha virtual care coordination versus treatment as usual (TAU), among HCV-infected patients enrolled in a NP-led mobile clinic | 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Treatment Adherence | Measured by pharmacy refills | 12 weeks |
| HCV Treatment Completion | Measured by 100% completion of 12-week treatment course |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health Upstate | Greenville | South Carolina | 29605 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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At time of randomization, participant is informed of study group assignment and provided instructions on use of app. Care provider is aware of group assignment as the provider is also using the platform to communicate with participants during course of treatment.
| 12 weeks |
| Rate of Sustained Virologic Response | Measured by end of treatment SVR labs | 6 months |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |