Hepatitis C Treatment in Probation and Parole Office

Sponsor

Jens Rosenau (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05413785

Collaborator

AbbVie (Industry)

150

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C HCV	Behavioral: Telehealth in Parole/Probation Office	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Hepatitis C Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Participants with Hepatitis C

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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