Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533319
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Hepatitis C Treatment in Idaho County Jails
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Screening and Treatment for Chronic Hepatitis C Infection of Persons Incarcerated in the County Jail Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None