An interventional study of Virtual Care Coordination in Hepatitis C and Substance Use Disorders, sponsored by Prisma Health-Upstate. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Prisma Health-Upstate · Not applicable, Interventional, and Treatment
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%.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 146 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Prisma Health-Upstate is the lead sponsor of 74 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment
Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment
Behavioral: Virtual Care Coordination
Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.
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
Time frame: 27 months
HCV Treatment Adherence
Measured by pharmacy refills
Time frame: 12 weeks
HCV Treatment Completion
Measured by 100% completion of 12-week treatment course
Time frame: 12 weeks
Rate of Sustained Virologic Response
Measured by end of treatment SVR labs
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Prisma Health-Upstate