NCT05369507

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

May 5, 2022

Last Update Submit

April 18, 2024

Conditions

Hepatitis CSubstance Use Disorders

Keywords

Mobile healthNurse practitionerCare coordinationVirtual care coordinationPeople who inject drugsRural health

Outcome Measures

Primary Outcomes (1)

  • 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

    27 months

Secondary Outcomes (3)

  • HCV Treatment Adherence

    12 weeks

  • HCV Treatment Completion

    12 weeks

  • Rate of Sustained Virologic Response

    6 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

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

Virtual Care Coordination

EXPERIMENTAL

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

Behavioral: Virtual Care Coordination

Interventions

Virtual Care CoordinationBEHAVIORAL

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

Virtual Care Coordination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health Upstate

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Hepatitis CSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 11, 2022

Study Start

September 1, 2021

Primary Completion

September 16, 2023

Study Completion

September 16, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)