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Telehealth for Hepatitis C Treatment
N/A
Recruiting
Led By Jens Rosenau, MD
Research Sponsored by Jens Rosenau
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of hepatitis C
Be older than 18 years old
Must not have
Subjects with impaired capacity to provide informed consent
HIV or HBV co-infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trialwill investigate if providing HCV treatment through a P&P office using telemedicine can help people get treatment without needing to travel to a specialist's office.
Who is the study for?
This trial is for individuals on probation or parole with a history of hepatitis C who will be supervised at the office for at least 5 months. They must have health insurance, be able to consent to the study, and have a life expectancy over one year. It's not open to those without active hepatitis C infection, pregnant or breastfeeding women, people co-infected with HIV/HBV, or those with severe liver cirrhosis.
What is being tested?
The study tests if telehealth services in a probation and parole office can effectively link patients to hepatitis C care and treatment compared to previous methods. Participants receive consultations from HCV experts via telemedicine during regular appointments without extra travel.
What are the potential side effects?
Since this trial focuses on service delivery rather than medication side effects are not detailed here. However, typical HCV treatments may include headaches, fatigue, nausea which would be monitored by healthcare providers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had hepatitis C in the past.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am unable to understand or sign the consent form by myself.
Select...
I am co-infected with HIV or hepatitis B.
Select...
My liver is severely damaged, with a score indicating advanced disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
HCV treatment uptake rate of HCV RNA positive participants
Secondary study objectives
Determine visit adherence
HCV treatment uptake rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with Hepatitis CExperimental Treatment1 Intervention
Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.
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Who is running the clinical trial?
AbbVieIndustry Sponsor
1,029 Previous Clinical Trials
521,380 Total Patients Enrolled
110 Trials studying Hepatitis C
32,679 Patients Enrolled for Hepatitis C
Jens RosenauLead Sponsor
1 Previous Clinical Trials
657 Total Patients Enrolled
1 Trials studying Hepatitis C
657 Patients Enrolled for Hepatitis C
Jens Rosenau, MDPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
657 Total Patients Enrolled
1 Trials studying Hepatitis C
657 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand or sign the consent form by myself.I am co-infected with HIV or hepatitis B.I have had hepatitis C in the past.My liver is severely damaged, with a score indicating advanced disease.I can sign and understand the consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Hepatitis C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hepatitis C Patient Testimony for trial: Trial Name: NCT05413785 — N/A
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