Hepatitis C Treatment in Idaho County Jails

July 29, 2024 updated by: Eastern Idaho Public Health

Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting

To explore the feasibility of opt in Hepatitis C Virus (HCV) screening and initiation of HCV treatment during incarceration in county jails including;

  1. incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
  2. incarcerated persons positive for HCV in jails less than the duration of 12 weeks of treatment who receive remaining supply of study drug on discharge with appropriate linkage to care.

Assess quality of life measures in participants being treated for their HCV through the validated questionnaire EuroQol-5D at baseline and post-treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aligning with the World Health Organization (WHO) global guidance and recommendation to eliminate viral hepatitis by 2030 will require designated focus on priority populations who are disproportionately impacted by viral hepatitis. Addressing chronic hepatitis C virus (HCV) with the justice involved population is crucial in reducing HCV within the greater population. Inmate populations bear a disproportionate share of the burden of HCV infection. HCV prevalence is 10-20 fold greater in the incarcerated population than the general population, although wider uptake among people who are incarcerated remains limited. Addressing HCV in the incarcerated population is a strategy to bring the US closer to successfully eradicating the HCV epidemic. Additionally, previous qualitative research has suggested that justice involved individuals felt incarceration is an apt time to initiate treatment and is a missed opportunity to not do so, and that waiting and initiating treatment upon release faces multiple challenges, including insurance or Medicaid enrollment, making appointments, transportation and work commitments.

HCV in the jail setting is a public health issue that needs to be addressed. Extensive modelling has shown that HCV testing in people who are incarcerated prevents community spread of HCV and is cost effective. Furthermore, there is guidance and recommendations for HCV testing in the prison system where a vast majority of research is being conducted. However, there is limited guidance for HCV testing within jails. Thus, county jails are critical partners, and potentially may serve as an important setting for HCV screening, diagnosis and treatment, although data is scarce in this realm. We therefore aim to explore whether county jails are a practical and feasible setting for HCV screening, and initiating HCV treatment, including whether an incarcerated person resides in the county jail for the duration of treatment (group 1), or is released to the community in the midst of treatment with a supply of remaining study drug and linked to appropriate care (group 2).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
  • All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
  • Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis.

Exclusion Criteria:

  • All participants greater than 18 years old and incarcerated in an Idaho county jail greater than 10 days.
  • All participants who are not sentenced to prison terms at Idaho Department of Corrections (IDOC). Participants sentenced to IDOC will receive screening and treatment per IDOC policy.
  • Participants diagnosed with HCV and qualify for the AASLD Simplified Treatment Algorithm for Treatment Nave Adults Without Cirrhosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail
Patients infected with chronic hepatitis C who are also incarcerated will be enrolled into the study and provided FDA approved Epclusa (sofosbuvir/velpatasvir) for treatment of chronic hepatitis C. Epclusa (sofosbuvir/velpatasvir) is currently used as a first line treatment for chronic hepatitis C. This study will focus on effectiveness of treatment in the county jai setting.
Drug: sofosbuvir/velpatasvir
Patients who qualify for the study will be provided with sofosbuvir/velpatasvir for chronic hepatitis C treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virologic Response
Time Frame: 12 weeks after treatment
Undetectable hepatitis C RNA
12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life improvement
Time Frame: At study enrollment and 12 weeks after treatment
Improvement in quality of life measures after treatment of hepatitis C as measured by SF-12 tool
At study enrollment and 12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Idaho Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-US-342-7112

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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