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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-09-16

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%.

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Detailed Description

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Conditions

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Hepatitis C Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Treatment as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Virtual Care Coordination

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

Group Type EXPERIMENTAL

Virtual Care Coordination

Intervention Type BEHAVIORAL

Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.

Interventions

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Virtual Care Coordination

Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.

Intervention Type BEHAVIORAL

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