HCV, Hepatitis C
Conditions
Keywords
parole, probation, telemedicine
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.
Interventions
BEHAVIORALTelehealth 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.
Sponsors
AbbVie
Jens Rosenau
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV treatment uptake rate of HCV RNA positive participants | 6 months | Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HCV treatment uptake rate | 6 months | percentage of all chronically infected patients regardless of treatment eligibility |
| Determine visit adherence | 6 months | Number of kept visits divided by number of scheduled visits |
Countries
United States
Outcome results
None listed