Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination (STAT-C)
Primary Purpose
Hepatitis C, Substance Use Disorders
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Care Coordination
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health
Eligibility Criteria
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
Sites / Locations
- Prisma Health Upstate
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual
Virtual Care Coordination
Arm Description
TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment
Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
HCV Treatment Adherence
Measured by pharmacy refills
HCV Treatment Completion
Measured by 100% completion of 12-week treatment course
Rate of Sustained Virologic Response
Measured by end of treatment SVR labs
Full Information
NCT ID
NCT05369507
First Posted
May 5, 2022
Last Updated
March 27, 2023
Sponsor
Prisma Health-Upstate
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05369507
Brief Title
Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination
Acronym
STAT-C
Official Title
Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Substance Use Disorders
Keywords
Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
TAU group will receive standard care coordination efforts by health care team throughout course of HCV treatment
Arm Title
Virtual Care Coordination
Arm Type
Experimental
Arm Description
Participants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment
Intervention Type
Behavioral
Intervention Name(s)
Virtual Care Coordination
Intervention Description
Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.
Primary Outcome Measure Information:
Title
HCV Treatment Initiation Rates
Description
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
Time Frame
27 months
Secondary Outcome Measure Information:
Title
HCV Treatment Adherence
Description
Measured by pharmacy refills
Time Frame
12 weeks
Title
HCV Treatment Completion
Description
Measured by 100% completion of 12-week treatment course
Time Frame
12 weeks
Title
Rate of Sustained Virologic Response
Description
Measured by end of treatment SVR labs
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Prisma Health Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination
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