Telehealth for Hepatitis C Treatment

Recruiting in Palo Alto (17 mi)

Overseen by Jens Rosenau, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jens Rosenau

No Placebo Group

Trial Summary

What is the purpose of this trial?

This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P\&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P\&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference.

Research Team

Jens Rosenau, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

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.

Inclusion Criteria

Life expectancy >1 year

Able to obtain health insurance

Clients who will be supervised in the probation and parole office for at least 5 months

Exclusion Criteria

Pregnant or breast-feeding

Negative HCV RNA

I am unable to understand or sign the consent form by myself.

Treatment Details

Interventions

• Telehealth in Parole/Probation Office (Other)

Trial Overview 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.

Participant Groups

Group I: Participants with Hepatitis C Experimental Treatment 1 Intervention

Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.

Who Is Running the Clinical Trial?

Jens Rosenau

Lead Sponsor

Trials

2

Recruited

810+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois