Hepatitis C Treatment in Probation and Parole Office

Not Applicable

Completed

• Conditions: HCV; Hepatitis C

• Registration Number: NCT05413785
• Lead Sponsor: Jens Rosenau

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-10
• Study Start: 2022-08-23
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-09
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Clients who will be supervised in the probation and parole office for at least 5 months
• History of hepatitis C
• Able to obtain health insurance
• Capacity to provide written, informed consent
• Life expectancy >1 year

Exclusion Criteria

• Negative HCV RNA
• Pregnant or breast-feeding
• HIV or HBV co-infection
• Liver cirrhosis with Child-Turcotte-Pugh score 6 or greater at baseline lab work
• Subjects with impaired capacity to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HCV treatment uptake rate of HCV RNA positive participants	6 months	Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.

Secondary Outcome Measures

Name	Time	Method
Determine visit adherence	6 months	Number of kept visits divided by number of scheduled visits
HCV treatment uptake rate	6 months	percentage of all chronically infected patients regardless of treatment eligibility

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States