Hepatitis CNCT04798521
TeleHepC Treatment Trial
A study testing Tele-HCV and Community Linkage to Care in people with Hepatitis C, run by Oregon Health and Science University at 3 sites in United States.
Trial summary
The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Tele-HCV and Community Linkage to Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2020to 10 Jan 2024
- 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
- live in the study area
- have injected drugs or report recreational opioid use without injection in the last 90 days
- are age 18 or greater
- have chronic active, untreated hepatitis C (defined as positive HCV RNA)
- are seeking treatment for hepatitis C infection.
- are able to communicate in English (this is due to the fact that less than 5% of the population in which we are targeting will be non-English speaking; see "Non-English Speaking Subjects" for additional information).
- are enrolled in health insurance
Who cannot join
- Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including:
- increased abdominal or lower extremity swelling
- confusion consistent with hepatic encephalopathy
- Are pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Central City Concern
Portland, Oregon, 97205
Comagine Health
Portland, Oregon, 97232
HIV Alliance
Roseburg, Oregon, 97471
About this study
Official title: Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial
The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).
Read the detailed description
Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment.
In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV.
In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening.
A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.
- Conditions
- Hepatitis C
- Being tested
- Tele-HCV, Community Linkage to Care
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-HCVOther
Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
Community Linkage to CareOther
Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
| Study group | Role | What they receive |
|---|---|---|
| Tele-HCV Treatment | Experimental | Participants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit. Receives: Other: Tele-HCV |
| Community Linkage to Care | Active comparator | Participants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Receives: Other: Community Linkage to Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Response
Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
Measured: 12 weeks post treatment
Secondary outcomes (3)
Treatment Initiation
Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.
Measured: 4 weeks
Treatment Completion
HCV treatment completion, filled final prescription. 90% of HCV pills taken
Measured: 36 weeks post treatment
Engagement in Harm Reduction Resources
Participants complete surveys to assess whether or not they are regularly engaging in substance use and harm reduction resources in the community. Surveys conducted a Baseline, 12 weeks, and 36 weeks.
Measured: Baseline, 12 weeks, and 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start30 Jun 2020
- Primary completion25 Aug 2023
- Study completion10 Jan 2024
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Comagine Health, HIV Alliance, Oregon Health Authority
- Responsible party
- Principal investigator, P. Todd Korthuis, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798521
- Sponsor's protocol ID
- TeleHepC
- Other IDs
- UH3DA044831
- Status last verified
- Sep 2024
- First submitted
- 3 Jun 2020
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herink MC, Spencer HC, Cook RR, Gregoire D, Seaman A, Leichtling G, Babiarz J, Korthuis PT. Peer-assisted telemedicine for hepatitis C intervention in people experiencing housing instability. Harm Reduct J. 2026 Feb 5;23(1):49. doi: 10.1186/s12954-026-01408-y.
PubMed 41645194Seaman A, Cook R, Leichtling G, Herink MC, Gailey T, Cooper J, Spencer HC, Babiarz J, Fox C, Thomas A, Leahy JM, Larsen JE, Korthuis PT. Peer-Assisted Telemedicine for Hepatitis C in People Who Use Drugs: A Randomized Controlled Trial. Clin Infect Dis. 2025 Mar 17;80(3):501-508. doi: 10.1093/cid/ciae520.
PubMed 39602441Herink MC, Seaman A, Leichtling G, Larsen JE, Gailey T, Cook R, Thomas A, Korthuis PT. A randomized controlled trial for a peer-facilitated telemedicine hepatitis c treatment intervention for people who use drugs in rural communities: study protocol for the "peer tele-HCV" study. Addict Sci Clin Pract. 2023 May 27;18(1):35. doi: 10.1186/s13722-023-00384-z.
PubMed 37245041
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial
- ClinicalTrials.gov ID
- NCT04798521
- Acronym / sponsor ID
- TeleHepC
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Comagine Health, HIV Alliance, Oregon Health Authority
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to test the efficacy of a peer-facilitated telemedicine HCV treatment implementation strategy for people who use drugs versus local HCV treatment referral for achieving HCV sustained viral response at 12 weeks post-treatment (SVR12).
Detailed description
Non-blinded, randomized controlled trial. In-depth qualitative interviews assess attitudes and barriers to treatment.
In Phase 1, potential participants will be pulled from a convenience sample at a Portland clinic providing care for the urban area. An initial target sample of 100 Hepatitis C positive participants will be enrolled for DBS validation. Power will be reassessed based on feedback from receiver operating curve model and additional participants enrolled up to a total of 100 Hepatitis C Positive participants, if necessary. A total of 500 potential participants can be screened expecting 1 in every 4 participants will be positive HCV.
In Phase 2, rural peer care coordinators (PCCs) and research assistants recruit up to 200 PWUD participants from high-needs rural Oregon counties. Study staff specifically target untreated populations recruited from local syringe exchange programs and direct community outreach (e.g. community barbeques, parks, homeless shelters, food pantries, etc.). Participants are encouraged to refer others for study screening.
A subset of up to 40 study participants will complete in-depth qualitative interviews regarding their experiences of hepatitis C treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-HCV Treatment | Experimental | Other: Tele-HCVParticipants allocated to telemedicine intervention arm are scheduled for treatment assessment by a study clinician. For a majority of participants, this will also be the treatment initiation visit. If additional studies are necessary for routine treatment decision making, peers will assist participants in navigating health system barriers and arrangement of second telemedicine visit. |
| Community Linkage to Care | Active comparator | Other: Community Linkage to CareParticipants allocated to the community linkage-to-care arm will complete screening, be offered enrollment, and undergo informed consent as in the telemedicine arm. Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- live in the study area
- have injected drugs or report recreational opioid use without injection in the last 90 days
- are age 18 or greater
- have chronic active, untreated hepatitis C (defined as positive HCV RNA)
- are seeking treatment for hepatitis C infection.
Key exclusion criteria (4 listed)
- Have decompensated cirrhosis, defined as Child-Turcotte-Pugh (CTP) score of 7 or greater, or CTP B cirrhosis. CTP scoring is a composite of laboratory metrics (bilirubin, albumin, PT/INR) and clinical findings, including:
- Are 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 |
|---|---|---|
| Tele-HCVPatients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation. | Other | Tele-HCV Treatment |
| Community Linkage to CareFollowing study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider. | Other | Community Linkage to Care |
Primary outcome
Viral Response
Time frame: 12 weeks post treatment
Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.
3 secondary outcomes
Treatment Initiation
Time frame: 4 weeks
Treatment Completion
Time frame: 36 weeks post treatment
Engagement in Harm Reduction Resources
Time frame: Baseline, 12 weeks, and 36 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41645194Herink MC, Spencer HC, Cook RR, Gregoire D, Seaman A, Leichtling G, Babiarz J, Korthuis PT. Peer-assisted telemedicine for hepatitis C intervention in people experiencing housing instability. Harm Reduct J. 2026 Feb 5;23(1):49. doi: 10.1186/s12954-026-01408-y.
- Derived from this study: PubMed 39602441Seaman A, Cook R, Leichtling G, Herink MC, Gailey T, Cooper J, Spencer HC, Babiarz J, Fox C, Thomas A, Leahy JM, Larsen JE, Korthuis PT. Peer-Assisted Telemedicine for Hepatitis C in People Who Use Drugs: A Randomized Controlled Trial. Clin Infect Dis. 2025 Mar 17;80(3):501-508. doi: 10.1093/cid/ciae520.
- Derived from this study: PubMed 37245041Herink MC, Seaman A, Leichtling G, Larsen JE, Gailey T, Cook R, Thomas A, Korthuis PT. A randomized controlled trial for a peer-facilitated telemedicine hepatitis c treatment intervention for people who use drugs in rural communities: study protocol for the "peer tele-HCV" study. Addict Sci Clin Pract. 2023 May 27;18(1):35. doi: 10.1186/s13722-023-00384-z.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-HCV and Community Linkage to Care in people with Hepatitis C, run by Oregon Health and Science University at 3 sites 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 7 inclusion and 4 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 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 8 Oct 2024). 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?
Viral Response (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798521, which also lists 3 linked publications.
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 8 Oct 2024.