Clinical trial NCT06533319: Hepatitis C Treatment in Idaho County Jails
Official title: Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Eastern Idaho Public Health
Sponsor class: OTHER_GOV
First posted: 2024-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-site, prospective cohort study at Idaho county jails with quantitative methods and survey.
Primary purpose: TREATMENT

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. 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Virologic Response
timeFrame: 12 weeks after treatment
Secondary outcomes:
measure: Quality of life improvement
timeFrame: At study enrollment and 12 weeks after treatment
Other outcomes:
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