Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination

Not Applicable

Completed

• Conditions: Hepatitis C; Substance Use Disorders
• Interventions: Behavioral: Virtual Care Coordination

• Registration Number: NCT05369507
• Lead Sponsor: Prisma Health-Upstate

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 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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-11
• Primary Completion: 2023-09-16
• Study Completion: 2023-09-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Not previously treated with HCV direct-acting antiviral medications OR treatment-experienced and eligible for treatment with sofosbuvir/velpatasvir
• Age 18+
• Willing to be randomized to either emocha versus TAU arms
• Able to provide informed consent

Exclusion Criteria

• Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Care Coordination	Virtual Care Coordination	Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment

Primary Outcome Measures

Name	Time	Method
HCV Treatment Initiation Rates	27 months	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

Secondary Outcome Measures

Name	Time	Method
HCV Treatment Completion	12 weeks	Measured by 100% completion of 12-week treatment course
Rate of Sustained Virologic Response	6 months	Measured by end of treatment SVR labs
HCV Treatment Adherence	12 weeks	Measured by pharmacy refills

Trial Locations

Locations (1)

Prisma Health Upstate; 🇺🇸 Greenville, South Carolina, United States