Telehealth for Hepatitis C Treatment

Overseen By Nazanin Hooman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jens Rosenau

Disqualifiers: Negative HCV RNA, Pregnant, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

77 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether telehealth can improve treatment for people with hepatitis C who are on probation or parole. Instead of traveling to a specialist, participants will meet with healthcare providers through video calls during their regular probation or parole appointments. The researchers aim to determine if this approach is as effective as traditional methods by comparing it with past results where people were referred to care. This trial suits those who have hepatitis C, are on probation or parole for at least five months, and can access health insurance. Participants must have a life expectancy of more than one year and be able to give written consent. As an unphased trial, this study offers a unique opportunity to explore innovative care methods that could make treatment more accessible and convenient.

What prior data suggests that telehealth in a parole/probation office is safe for Hepatitis C treatment?

Research has shown that telehealth is a safe and effective way to treat Hepatitis C (HCV). Studies found that 90% of patients treated through telehealth were cured of HCV, compared to only 39% of those who received regular care.

Telehealth allows patients to receive treatment without traveling to a specialist, which is especially helpful for people on probation or parole. The treatment involves video calls with a healthcare provider and a pharmacist, who guide and monitor the treatment closely to ensure safety.

Regarding safety, the treatment for Hepatitis C used in telehealth follows established medical guidelines, meaning it has been tested and is considered safe. No specific reports of serious side effects related to the telehealth method itself exist. However, participants should discuss any concerns with their healthcare team during telehealth appointments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of telehealth for treating Hepatitis C because it offers a unique way to reach individuals who might otherwise have limited access to healthcare. Unlike traditional treatments that require frequent in-person visits to clinics or hospitals, this approach leverages technology to deliver care directly in parole and probation offices. This method could significantly increase treatment accessibility and adherence, especially for those in the criminal justice system, potentially leading to better health outcomes and reduced transmission rates.

What evidence suggests that telehealth in a parole/probation office is effective for Hepatitis C treatment?

Research has shown that telemedicine effectively treats Hepatitis C, particularly in settings like probation and parole offices. In this trial, participants will receive treatment through telehealth at the Lexington Probation and Parole office. Studies have found that about 90 percent of patients with Hepatitis C treated via telehealth were cured, a significant improvement over the 39 percent cured with regular care. Telehealth simplifies access to specialists and necessary care without extensive travel. This method has been especially successful for individuals with opioid use disorder, demonstrating that telehealth can effectively deliver Hepatitis C treatment. ^{4 6 7 8 9}

Who Is on the Research Team?

Jens Rosenau, MD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals on probation or parole with a history of hepatitis C who will be supervised at the office for at least 5 months. They must have health insurance, be able to consent to the study, and have a life expectancy over one year. It's not open to those without active hepatitis C infection, pregnant or breastfeeding women, people co-infected with HIV/HBV, or those with severe liver cirrhosis.

Inclusion Criteria

Life expectancy >1 year

Able to obtain health insurance

Clients who will be supervised in the probation and parole office for at least 5 months

Exclusion Criteria

Pregnant or breast-feeding

Negative HCV RNA

I am unable to understand or sign the consent form by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telemedicine-supported HCV treatment in a probation and parole office setting

6 months

Regularly scheduled appointments at P&P office

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth in Parole/Probation Office

Trial Overview The study tests if telehealth services in a probation and parole office can effectively link patients to hepatitis C care and treatment compared to previous methods. Participants receive consultations from HCV experts via telemedicine during regular appointments without extra travel.

How Is the Trial Designed?

Group I: Participants with Hepatitis C Experimental Treatment 1 Intervention

Participants will be clients at the Lexington Probation and Parole office who are Hepatitic C positive.

Who Is Running the Clinical Trial?

Jens Rosenau

Lead Sponsor

Trials

2

Recruited

810+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05413785?term=parole&viewType=Table&rank=1&checkSpell=

Hepatitis C Treatment in Probation and Parole Office | ... ... Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office ... Telemedicine. Plan for Individual Participant Data (IPD).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12457984/

Long‐Term Benefits Following Hepatitis C Cure Through ... Facilitated telemedicine is highly effective for hepatitis C virus (HCV) treatment among people with opioid use disorder (OUD).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12522442/

Opioid treatment program-integrated facilitated ... We evaluated two outcome measures: (1) HCV treatment effectiveness, defined by the percentage of individuals who achieved an SVR, and (2) ...

4. pcori.org pcori.org/research-results/2016/using-telehealth-improve-access-hepatitis-c-virus-treatment-patients-opioid-use-disorder-team-c-study

Using Telehealth to Improve Access to Hepatitis C Virus ... 90 percent of patients with HCV who received treatment through supported telehealth had their HCV cured compared with 39 percent of patients who received usual ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421003682

Patient-centered HCV care via telemedicine for individuals ... Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05413785?cond=parole&viewType=Table&checkSpell=&rank=1

Hepatitis C Treatment 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10886909/

Hepatitis B and Hepatitis C among Adults on Probation or ... About 6.4% of adults on parole reported a diagnosis of hepatitis B or hepatitis C, which was significantly higher than adults on probation only (3.2%).

8. liebertpub.com liebertpub.com/doi/10.1089/jchc.23.03.0025?doi=10.1089/jchc.23.03.0025

Outcomes of Pharmacist-Led Treatment of Hepatitis C in ... The objective of this retrospective cohort study was to describe the HCV treatment cascade in a pharmacist-led clinic model, from referral through treatment ...

9. uscourts.gov uscourts.gov/file/23041/download

Hepatitis C Among Offenders– Correctional Challenge and ... In rare cases, clinically advanced disease can lead to major and potentially fatal complications, with implications for sentencing, classification, probation ...