N/A
N=203
TeleHepC Treatment Trial
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT04798521 ↗Enrolled (actual)
203
Serious AEs
2.5%
Results posted
Oct 2024
Primary outcome: Primary: Viral Response — 63; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tele-HCV (Other); Community Linkage to Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Response |
63; 16 | — |
| SECONDARY Treatment Initiation |
85; 13 | — |
| SECONDARY Treatment Completion |
46; 9 | — |
| SECONDARY Engagement in Harm Reduction Resources |
100; 103; 88; 83; 61; 68 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04798521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.