UK Center for Clinical and Translational Science

Hepatitis C Treatment in Probation and Parole Office

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Health Services Research
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID: NCT05413785
Status: Recruiting
Sponsor: Jens Rosenau

Study Contact

Nazanin Hooman
(859) 257-3383
n.hooman@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.