TeleHepC Treatment Trial
- Conditions
- Hepatitis C
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- 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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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)
Central City Concern
🇺🇸Portland, Oregon, United States
Comagine Health
🇺🇸Portland, Oregon, United States
HIV Alliance
🇺🇸Roseburg, Oregon, United States
Central City Concern🇺🇸Portland, Oregon, United States