Back to resultsHepatitis C Treatment in Probation and Parole Office
Primary Purpose
Hepatitis C, HCV
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth in Parole/Probation Office
Sponsored by
About this trial
This is an interventional health services research trial for Hepatitis C focused on measuring parole, probation, telemedicine
Eligibility Criteria
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
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants with Hepatitis C
Arm Description
Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.
Outcomes
Primary Outcome Measures
HCV treatment uptake rate of HCV RNA positive participants
Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.
Secondary Outcome Measures
HCV treatment uptake rate
percentage of all chronically infected patients regardless of treatment eligibility
Determine visit adherence
Number of kept visits divided by number of scheduled visits
Full Information
NCT ID
NCT05413785
First Posted
June 7, 2022
Last Updated
April 18, 2023
Sponsor
Jens Rosenau
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT05413785
Brief Title
Hepatitis C Treatment in Probation and Parole Office
Official Title
Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rosenau
Collaborators
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HCV
Keywords
parole, probation, telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants with Hepatitis C
Arm Type
Experimental
Arm Description
Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth in Parole/Probation Office
Intervention Description
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.
Primary Outcome Measure Information:
Title
HCV treatment uptake rate of HCV RNA positive participants
Description
Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HCV treatment uptake rate
Description
percentage of all chronically infected patients regardless of treatment eligibility
Time Frame
6 months
Title
Determine visit adherence
Description
Number of kept visits divided by number of scheduled visits
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammi Gausepohl
Phone
8592573383
Email
tammi.gausepohl@uky.edu
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hepatitis C Treatment in Probation and Parole Office
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