Hepatitis C Treatment in Probation and Parole Office

Study Overview
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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.

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

Conditions
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HCV, Hepatitis C

Intervention / Treatment
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* Behavioral: Telehealth in Parole/Probation Office


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Hepatitis C<br>Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive. | Behavioral: Telehealth in Parole/Probation Office<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV treatment uptake rate | percentage of all chronically infected patients regardless of treatment eligibility | 6 months | 
| Determine visit adherence | Number of kept visits divided by number of scheduled visits | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parole, probation, telemedicine