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Clinical Trials/NCT05413785
NCT05413785
Completed
N/A

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

Jens Rosenau1 site in 1 country77 target enrollmentAugust 23, 2022
ConditionsHepatitis CHCV

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hepatitis C
Sponsor
Jens Rosenau
Enrollment
77
Locations
1
Primary Endpoint
HCV treatment uptake rate of HCV RNA positive participants
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 23, 2022
End Date
May 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Jens Rosenau

Associate Professor

University of Kentucky

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

Outcomes

Primary Outcomes

HCV treatment uptake rate of HCV RNA positive participants

Time Frame: 6 months

Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.

Secondary Outcomes

  • HCV treatment uptake rate(6 months)
  • Determine visit adherence(6 months)

Study Sites (1)

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