TeleHepC Treatment Trial

NCT04798521 | Completed Results DMC

• 2 other identifiers: TeleHepCUH3DA044831
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Viral Response

  Number of participants with sustained viral response post HCV treatment. The viral response will be measured via a blood test.

  12 weeks post treatment

Secondary Outcomes (3)

• Treatment Initiation

  4 weeks

• Treatment Completion

  36 weeks post treatment

• Engagement in Harm Reduction Resources

  Baseline, 12 weeks, and 36 Weeks

Study Arms (2)

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.

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.

Other: Community Linkage to Care

Interventions

Tele-HCV OTHER

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.

Tele-HCV Treatment

Community Linkage to Care OTHER

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.

Community Linkage to Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Comagine Health: collaborator
• HIV Alliance: collaborator
• Oregon Health Authority: collaborator

Study Sites (3)

Central City Concern

Portland, Oregon, 97205, United States

Location

Comagine Health

Portland, Oregon, 97232, United States

Location

HIV Alliance

Roseburg, Oregon, 97471, United States

Location

Related Publications (2)

• Seaman 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.

  PMID: 39602441 DERIVED

• Herink 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.

  PMID: 37245041 DERIVED

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. P. Todd Korthuis
• Organization: Oregon Health & Science University

korthuis@ohsu.edu

503-494-8044

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: March 15, 2021
• Study Start: June 30, 2020
• Primary Completion: August 25, 2023
• Study Completion: January 10, 2024
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)