Hepatitis CSTAT-CNCT05369507
Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination
A study testing Virtual Care Coordination in people with Hepatitis C and Substance Use Disorders, run by Prisma Health-Upstate at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Substance Use Disorders
- What is being tested?
- Virtual Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 16 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Upstate
Greenville, South Carolina, 29605
About this study
Official title: Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics
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%.
- Conditions
- Hepatitis C, Substance Use Disorders
- Being tested
- Virtual Care Coordination
- Keywords
- Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Care CoordinationBehavioural
Participants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Virtual Care Coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 27 months
Secondary outcomes (3)
HCV Treatment Adherence
Measured by pharmacy refills
Measured: 12 weeks
HCV Treatment Completion
Measured by 100% completion of 12-week treatment course
Measured: 12 weeks
Rate of Sustained Virologic Response
Measured by end of treatment SVR labs
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Sep 2021
- Primary completion16 Sep 2023
- Study completion16 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369507
- Sponsor's protocol ID
- Pro00106348
- Acronym
- STAT-C
- Status last verified
- Apr 2024
- First submitted
- 5 May 2022
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics
- ClinicalTrials.gov ID
- NCT05369507
- Acronym / sponsor ID
- STAT-C / Pro00106348
- Conditions
- Hepatitis C, Substance Use Disorders
- Keywords
- Mobile health, Nurse practitioner, Care coordination, Virtual care coordination, People who inject drugs, Rural health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 16 Sep 2023 (actual)
- Study completion
- 16 Sep 2023 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Virtual Care CoordinationParticipants will download a mobile phone app (emocha) to facilitate care coordination throughout course of HCV treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Care CoordinationParticipants randomly assigned to the virtual care coordination group will use a mobile app to assist in HCV treatment care coordination. | Behavioural | Virtual Care Coordination |
Primary outcome
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
3 secondary outcomes
HCV Treatment Adherence
Time frame: 12 weeks
HCV Treatment Completion
Time frame: 12 weeks
Rate of Sustained Virologic Response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care Coordination in people with Hepatitis C and Substance Use Disorders, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV Treatment Initiation Rates (time frame: 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.