Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05369507
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2022-05-05
Brief Title:
Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination
Sponsor:
Prisma Health-Upstate
Organization:
Prisma Health-Upstate
Study Overview
Official Title:
Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAT-C
Brief Summary:
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 screeningtreatment resources NPs will provide HCV care through mobile health units Participants will be randomized 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None