Hepatitis C Treatment in Probation and Parole Office

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413785
• Other study ID #: IMDDN-22-HEP-C-TX
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: Tammi Gausepohl
• Phone: 8592573383
• Email: tammi.gausepohl[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• HCV
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Jens Rosenau	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HCV treatment uptake rate	percentage of all chronically infected patients regardless of treatment eligibility	6 months
Secondary	Determine visit adherence	Number of kept visits divided by number of scheduled visits	6 months