Ignite Creation Date:
2024-05-06 @ 2:11 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04235049
Status:
WITHDRAWN
Last Update Posted:
2021-05-06
First Post:
2020-01-10
Brief Title:
Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations ECLIPSE
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Department of Corrections unable to support study at this time and find agreement on publication issue
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECLIPSE
Brief Summary:
Hepatitis C HCV is a chronic infection with significant morbidity and mortality The development of directly acting antivirals DAA has dramatically improved the cure rate of HCV treatment People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease However despite availability of effective treatment people who experience incarceration are often unable to access this curative therapy and are often not readily engaged in medical care upon release This perpetuates transmission and progression of disease in an incredibly high risk marginalized population Therefore in order to effectively eliminate HCV it is imperative that the epidemic of HCV in prisons is addressed and that models of care are established for treatment of HCV in incarcerated individuals both during and after incarceration
As such the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison This care is provided in conjunction with collocated services to prevent HCV reinfection including opioid agonist therapy This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals while simultaneously treating opioid use disorder and preventing HCV reinfection
As such the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison This care is provided in conjunction with collocated services to prevent HCV reinfection including opioid agonist therapy This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals while simultaneously treating opioid use disorder and preventing HCV reinfection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None