Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination (STAT-C)

Prisma Health-Upstate

Status: Completed

Conditions: Hepatitis C; Substance Use Disorders

Treatments: Behavioral: Virtual Care Coordination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05369507

Pro00106348

Details and patient eligibility

About

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%.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Treatment as Usual

No Intervention group

Description:

TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment

Virtual Care Coordination

Experimental group

Description:

Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment

Treatment:

Behavioral: Virtual Care Coordination