Hepatitis CNCT05413785
Hepatitis C Treatment in Probation and Parole Office
A study testing Telehealth in Parole/Probation Office in people with Hepatitis C and HCV, run by Jens Rosenau at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatitis C, HCV
- What is being tested?
- Telehealth in Parole/Probation Office
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office
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
- Hepatitis C, HCV
- Being tested
- Telehealth in Parole/Probation Office
- Keywords
- parole, probation, telemedicine
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth in Parole/Probation OfficeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Hepatitis C | Experimental | Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive. Receives: Behavioral: Telehealth in Parole/Probation Office |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV treatment uptake rate of HCV RNA positive participants
Percentage of treatment uptake among treatment eligible patients seen by a provider via telemedicine.
Measured: 6 months
Secondary outcomes (2)
HCV treatment uptake rate
percentage of all chronically infected patients regardless of treatment eligibility
Measured: 6 months
Determine visit adherence
Number of kept visits divided by number of scheduled visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start23 Aug 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Rosenau
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor-investigator, Jens Rosenau, University of Kentucky
- Investigators
- Jens Rosenau, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413785
- Sponsor's protocol ID
- IMDDN-22-HEP-C-TX
- Status last verified
- Sep 2024
- First submitted
- 7 Jun 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office
- ClinicalTrials.gov ID
- NCT05413785
- Acronym / sponsor ID
- IMDDN-22-HEP-C-TX
- Conditions
- Hepatitis C, HCV
- Keywords
- parole, probation, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Jens RosenauUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Hepatitis C | Experimental | Behavioral: Telehealth in Parole/Probation OfficeParticipants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth in Parole/Probation OfficeOnsite (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. | Behavioural | Participants with Hepatitis C |
Primary outcome
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.
2 secondary outcomes
HCV treatment uptake rate
Time frame: 6 months
Determine visit adherence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rosenau, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth in Parole/Probation Office in people with Hepatitis C and HCV, run by Jens Rosenau at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCV treatment uptake rate of HCV RNA positive participants (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.