Hepatitis C Treatment in Probation and Parole Office

NCT ID: NCT05413785

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2024-05-31

Brief Summary

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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

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Conditions

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Hepatitis C HCV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Participants with Hepatitis C

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

Group Type EXPERIMENTAL

Telehealth in Parole/Probation Office

Intervention Type 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.

Interventions

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Telehealth in Parole/Probation Office

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role collaborator

Jens Rosenau

OTHER

Sponsor Role lead

Responsible Party

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Jens Rosenau

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens Rosenau, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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IMDDN-22-HEP-C-TX

Identifier Type: -

Identifier Source: org_study_id

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