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OpenTrials
Completed

NCT Number: NCT05369507

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Care Coordination

Behavioral

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

Primary outcomes

  1. HCV Treatment Initiation Rates

    Time frame: 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 outcomes

  1. HCV Treatment Adherence

    Time frame: 12 weeks

    Measured by pharmacy refills

  2. HCV Treatment Completion

    Time frame: 12 weeks

    Measured by 100% completion of 12-week treatment course

  3. Rate of Sustained Virologic Response

    Time frame: 6 months

    Measured by end of treatment SVR labs

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Acronym: STAT-C

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 11, 2022
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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