Hepatitis C Treatment in Probation and Parole Office

NCT05413785 | Completed

• 1 other identifier: IMDDN-22-HEP-C-TX
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C; HCV

Keywords

parole; probation; telemedicine

Outcome Measures

Primary Outcomes (1)

• HCV treatment uptake rate of HCV RNA positive participants

  Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.

  6 months

Secondary Outcomes (2)

• HCV treatment uptake rate

  6 months

• Determine visit adherence

  6 months

Study Arms (1)

Participants with Hepatitis C

EXPERIMENTAL

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

Behavioral: Telehealth in Parole/Probation Office

Interventions

Telehealth in Parole/Probation Office BEHAVIORAL

Onsite (telehealth) linkage toHep C treatment in a Probation and Parole office setting via an onsite nurse navigator. The navigator will provide Hep C education, draw labs, and facilitate a telemed visit with a UK GI provider.

Participants with Hepatitis C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jens Rosenau: lead
• AbbVie: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jens Rosenau, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: August 23, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 22, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)