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

Hepatitis C Clinical Trial

— STAT-C  

Official title:

Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369507
• Other study ID #: Pro00106348
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 16, 2023

Study information

• Verified date: April 2024
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 16, 2023
• Est. primary completion date: September 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Prisma Health Upstate	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	HCV Treatment Adherence	Measured by pharmacy refills	12 weeks
Secondary	HCV Treatment Completion	Measured by 100% completion of 12-week treatment course	12 weeks
Secondary	Rate of Sustained Virologic Response	Measured by end of treatment SVR labs	6 months