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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
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 5, 2022
Last Updated
March 27, 2023
Sponsor
Prisma Health-Upstate
Collaborators
Gilead Sciences
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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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