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

Study Overview
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Brief Summary
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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%.

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

Conditions
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Hepatitis C, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Virtual Care Coordination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual<br>TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment | |
| Experimental: Virtual Care Coordination<br>Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment | Behavioral: Virtual Care Coordination<br>* Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health