TeleHepC Treatment Trial

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Other: Tele-HCV; Other: Community Linkage to Care

• Registration Number: NCT04798521
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2020-06-03
• Study Start: 2020-06-30
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Primary Completion: 2023-08-25
• Study Completion: 2024-01-10
• Results First Submitted: 2024-08-23
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Results First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-HCV Treatment	Tele-HCV	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.
Community Linkage to Care	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.

Primary Outcome Measures

Name	Time	Method
Viral Response	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 Outcome Measures

Name	Time	Method
Treatment Initiation	4 weeks	Number of participants who initiated Hepatitis-C Virus (HCV)treatment at 4 weeks post study enrollment.
Treatment Completion	36 weeks post treatment	HCV treatment completion, filled final prescription. 90% of HCV pills taken
Engagement in Harm Reduction Resources	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.

Trial Locations

Locations (3)

Comagine Health; 🇺🇸 Portland, Oregon, United States

HIV Alliance; 🇺🇸 Roseburg, Oregon, United States

Central City Concern; 🇺🇸 Portland, Oregon, United States