Hepatitis C Treatment in Idaho County Jails

NCT06533319 | Not Yet Recruiting

• 1 other identifier: CO-US-342-7112
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

1. 1.incarcerated persons positive for HCV who remain in jail for duration of 12 weeks of treatment and
2. 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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response

  Undetectable hepatitis C RNA

  12 weeks after treatment

Secondary Outcomes (1)

• Quality of life improvement

  At study enrollment and 12 weeks after treatment

Study Arms (1)

Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail

OTHER

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

Interventions

sofosbuvir/velpatasvir DRUG

Patients who qualify for the study will be provided with sofosbuvir/velpatasvir for chronic hepatitis C treatment.

Patients infected with chronic hepatitis C who are also incarcerated in an Idaho county jail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Idaho Public Health: lead

MeSH Terms

Conditions

Hepatitis C

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All study components will be blind to individuals in charge of the study, with the exception of the prescribing clinician and primary investigator.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Multi-site, prospective cohort study at Idaho county jails with quantitative methods and survey.

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07