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NCT Number: NCT04798521

TeleHepC 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central City Concern, Portland, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Treatment Initiation

    Time frame: 4 weeks

    Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.

  2. Treatment Completion

    Time frame: 36 weeks post treatment

    HCV treatment completion, filled final prescription. 90% of HCV pills taken

  3. Engagement in Harm Reduction Resources

    Time frame: Baseline, 12 weeks, and 36 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Comagine Health
  • HIV Alliance
  • Oregon Health Authority

Registry information

Official study title

Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 15, 2021
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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