N/A
N=156
Comparison of Telemedicine to Usual Care for HCV Management for Methadone-maintained Individuals
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02933970 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication — 106; 246 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telemedicine (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Andrew Talal
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Percentage of Patients in Both Arms Who Achieve Viral Eradication |
106; 246 | — |
| SECONDARY Comparison of Treatment Initiation Percentages |
126; 268 | — |
| SECONDARY Comparison of Treatment Completion Rates |
116; 261 | — |
| SECONDARY Comparison of Patient Satisfaction |
91.5; 98.3; 91.5; 98.7 | — |
Summary
To compare the effectiveness of a patient-centered, opiate agonist treatment (OAT)-integrated telemedicine-based approach for management and delivery of hepatitis C virus (HCV) treatment to persons with substance use disorders (PWSUD) versus usual care, which we anticipate in most cases will be referral to an offsite location for HCV management. The effectiveness will be expressed through the primary patient centered and clinical outcome, achievement of viral eradication, defined as undetectable HCV RNA 12 weeks post-treatment cessation.
Eligibility Criteria
Inclusion Criteria
- HCV antibody detected
- Ability and willingness of subject or legal representative to provide written informed consent.
- 18 years of age
- A minimum of 12-month enrollment in the opiate agonist treatment program
- Likely to be adherent to the therapeutic regimen
- Covered by medical insurance
Exclusion Criteria
- Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain.
- <18 years of age
- < 12 months enrolled in an opiate agonist treatment program.
- Non-compliance with therapeutic regimen defined as three consecutive missed appointments that will result in a discussion between the principal investigator at the site and the study participant to determine the reason for the missed appointments. Continuation in the study for the participant will be assessed on a case-by-case basis between the study PI and the site PI.
- Lack of medical insurance coverage
- Ineligibility for HCV treatment
- Active treatment for HCV at the time of the study enrollment
Data sourced from ClinicalTrials.gov (NCT02933970). 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.