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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

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

ArmDescriptionAssigned 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

Tammi Gausepohl
8592573383
tammi.gausepohl@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.