Hepatitis C, ChronicNCT05397067
Linkage to Care for Persons With Hep C Infection
A study testing Peer specialist (PS), Incentives and telehealth visits in people with Hepatitis C, Chronic and Substance Use Disorders, run by Carilion Clinic at 1 site in United States.
Trial summary
Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Substance Use Disorders
- What is being tested?
- Peer specialist (PS), Incentives and telehealth visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older, positive Hepatitis C antibody test,
- elevated Hepatitis C RNA
- history of substance use disorder
Who cannot join
- under 18 years old,
- history of treatment of Hepatitis C infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Low Cost Solutions to Help Facilitate Linkage to Care for Persons With Hepatitis C Virus Infection
Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
This study evaluated whether community-based interventions, including peer support, incentives, telehealth, and phone access, improve linkage to care among individuals with hepatitis C and substance use disorders in Appalachia.
Read the detailed description
This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
The primary component of the study was a prospective interventional evaluation in which participants (N=60) were sequentially assigned to one of four cohorts: a control group and three intervention groups. All participants received peer support, with additional interventions introduced iteratively across cohorts, including incentive vouchers (e.g., food, transportation, phone), telehealth access, and provision of prepaid mobile phones to facilitate communication and engagement in care.
The primary outcome was attendance at the first HCV treatment visit.
The study used a pragmatic, quasi-experimental approach to evaluate the impact of these interventions on linkage to care. The goal was to assess whether addressing structural barriers such as transportation, communication access, and care navigation would improve engagement in HCV treatment among a high-risk population.
A qualitative component was conducted to inform intervention development and better understand barriers and facilitators to care. This included semi-structured interviews with patients and healthcare providers. Findings from the qualitative phase were used to refine intervention strategies but were not part of the interventional study population or quantitative outcome analyses.
- Conditions
- Hepatitis C, Chronic, Substance Use Disorders
- Being tested
- Peer specialist (PS), Incentives, telehealth visits, phone access
- Keywords
- Hepatitis C, Substance use disorder, Linkage to care
- Medical subject headings
- Hepatitis C, Chronic, Substance-Related Disorders, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer specialist (PS)Behavioural
These participants will receive PRS support
IncentivesBehavioural
These participants will receive incentives
telehealth visitsBehavioural
These participants will receive telehealth visits
phone accessBehavioural
These participants will receive pre-paid phones
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | patients receive standard of care |
| Arm 2 | Experimental | Patients received PRS support + incentive Receives: Behavioral: Peer specialist (PS); Behavioral: Incentives |
| Arm 3 | Experimental | Patients received PRS support + incentive + Telehealth visits Receives: Behavioral: Peer specialist (PS); Behavioral: Incentives; Behavioral: telehealth visits |
| Arm 4 | Experimental | Patients received PRS support + incentive + telehealth visit + phone Receives: Behavioral: Peer specialist (PS); Behavioral: Incentives; Behavioral: telehealth visits; Behavioral: phone access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Attendance at First Appointment
Number of participants who attended their first hepatitis C treatment appointment following diagnosis. Results are reported by study phase (time-based arms)
Measured: Through study completion, within 6 months of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start12 Jul 2022
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study used a quasi-experimental, sequential (interrupted time-series) design. Participants were assigned to one of four time-based cohorts based on when they were enrolled: (1) pre-implementation (standard of care), (2) arm 2 ntervention phase including peer specialist support and incentives (3) intervention phase including peer specialist support and incentives with telehealth, and (4) enhanced intervention phase including peer specialist support, incentives, telehealth, and phone access.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Mariana Gomez, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397067
- Sponsor's protocol ID
- IRB-21-1472
- Other IDs
- UL1TR003015
- Status last verified
- Jul 2026
- First submitted
- 23 May 2022
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Low Cost Solutions to Help Facilitate Linkage to Care for Persons With Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT05397067
- Acronym / sponsor ID
- IRB-21-1472
- Conditions
- Hepatitis C, Chronic, Substance Use Disorders
- Keywords
- Hepatitis C, Substance use disorder, Linkage to care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis C Virus (HCV) infection is an ongoing challenge in the United States, with an estimated 2.4 million individuals living with HCV in 2016. According to the Virginia Department of Health, over 11,500 people were living with HCV infection in 2017 with a rate of 170 reported cases/100,000 adults. This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
This study evaluated whether community-based interventions, including peer support, incentives, telehealth, and phone access, improve linkage to care among individuals with hepatitis C and substance use disorders in Appalachia.
Detailed description
This study evaluated community-based interventions to improve linkage to care (LTC) among individuals with hepatitis C virus (HCV) infection and substance use disorders in Appalachia.
The primary component of the study was a prospective interventional evaluation in which participants (N=60) were sequentially assigned to one of four cohorts: a control group and three intervention groups. All participants received peer support, with additional interventions introduced iteratively across cohorts, including incentive vouchers (e.g., food, transportation, phone), telehealth access, and provision of prepaid mobile phones to facilitate communication and engagement in care.
The primary outcome was attendance at the first HCV treatment visit.
The study used a pragmatic, quasi-experimental approach to evaluate the impact of these interventions on linkage to care. The goal was to assess whether addressing structural barriers such as transportation, communication access, and care navigation would improve engagement in HCV treatment among a high-risk population.
A qualitative component was conducted to inform intervention development and better understand barriers and facilitators to care. This included semi-structured interviews with patients and healthcare providers. Findings from the qualitative phase were used to refine intervention strategies but were not part of the interventional study population or quantitative outcome analyses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study used a quasi-experimental, sequential (interrupted time-series) design. Participants were assigned to one of four time-based cohorts based on when they were enrolled: (1) pre-implementation (standard of care), (2) arm 2 ntervention phase including peer specialist support and incentives (3) intervention phase including peer specialist support and incentives with telehealth, and (4) enhanced intervention phase including peer specialist support, incentives, telehealth, and phone access.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –patients receive standard of care |
| Arm 2 | Experimental | Behavioral: Peer specialist (PS), Behavioral: IncentivesPatients received PRS support + incentive |
| Arm 3 | Experimental | Behavioral: Peer specialist (PS), Behavioral: Incentives, Behavioral: telehealth visitsPatients received PRS support + incentive + Telehealth visits |
| Arm 4 | Experimental | Behavioral: Peer specialist (PS), Behavioral: Incentives, Behavioral: telehealth visits, Behavioral: phone accessPatients received PRS support + incentive + telehealth visit + phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older, positive Hepatitis C antibody test,
- elevated Hepatitis C RNA
- history of substance use disorder
Key exclusion criteria (2 listed)
- under 18 years old,
- history of treatment of Hepatitis C infection
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 |
|---|---|---|
| Peer specialist (PS)These participants will receive PRS support | Behavioural | Arm 2, Arm 3, Arm 4 |
| IncentivesThese participants will receive incentives | Behavioural | Arm 2, Arm 3, Arm 4 |
| telehealth visitsThese participants will receive telehealth visits | Behavioural | Arm 3, Arm 4 |
| phone accessThese participants will receive pre-paid phones | Behavioural | Arm 4 |
Primary outcome
Number of Participants With Attendance at First Appointment
Time frame: Through study completion, within 6 months of diagnosis
Number of participants who attended their first hepatitis C treatment appointment following diagnosis. Results are reported by study phase (time-based arms)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Peer specialist (PS), Incentives and telehealth visits in people with Hepatitis C, Chronic and Substance Use Disorders, run by Carilion Clinic 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 3 inclusion and 2 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 7 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Attendance at First Appointment (time frame: Through study completion, within 6 months of diagnosis). 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 7 Jul 2026.