TeleHepC Treatment Trial

NCT ID: NCT04798521

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2024-01-10

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tele-HCV Treatment

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.

Group Type: EXPERIMENTAL

Tele-HCV

Intervention Type: 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.

Community Linkage to Care

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.

Group Type: ACTIVE_COMPARATOR

Community Linkage to Care

Intervention Type: 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.

Interventions

Tele-HCV

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.

Intervention Type: OTHER

Community Linkage to Care

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. live in the study area

2. have injected drugs or report recreational opioid use without injection in the last 90 days

3. are age 18 or greater

4. have chronic active, untreated hepatitis C (defined as positive HCV RNA)

5. are seeking treatment for hepatitis C infection.

6. 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).

7. are enrolled in health insurance

Exclusion Criteria

1. 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:

1. increased abdominal or lower extremity swelling

2. confusion consistent with hepatic encephalopathy

2. Are pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comagine Health

OTHER

Sponsor Role: collaborator

HIV Alliance

OTHER

Sponsor Role: collaborator

Oregon Health Authority

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

P. Todd Korthuis, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Central City Concern

Portland, Oregon, United States

Comagine Health

Portland, Oregon, United States

HIV Alliance

Roseburg, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39602441 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37245041 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UH3DA044831

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TeleHepC

Identifier Type: -

Identifier Source: org_study_id