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OpenTrials
Completed

NCT Number: NCT05413785

Hepatitis C Treatment in Probation and Parole Office

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. HCV treatment uptake rate of HCV RNA positive participants

    Time frame: 6 months

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

Secondary outcomes

  1. HCV treatment uptake rate

    Time frame: 6 months

    percentage of all chronically infected patients regardless of treatment eligibility

  2. Determine visit adherence

    Time frame: 6 months

    Number of kept visits divided by number of scheduled visits

Sponsors and collaborators

Lead sponsor

Jens Rosenau

Other

Collaborators

  • AbbVie

Registry information

Official study title

Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 10, 2022
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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