Hepatitis C, Substance Use Disorders
Conditions
Keywords
Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health
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%.
Interventions
BEHAVIORALVirtual Care Coordination
Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.
Sponsors
Gilead Sciences
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
At time of randomization, participant is informed of study group assignment and provided instructions on use of app. Care provider is aware of group assignment as the provider is also using the platform to communicate with participants during course of treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| HCV Treatment Adherence | 12 weeks | Measured by pharmacy refills |
| 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 |
Countries
United States
Outcome results
None listed