NCT04235049

Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)

Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	Glecaprevir/pibrentasvir	Treatment for HCV Infection

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-03-30
• Completion: 2024-10-30
• First posted: 2020-01-21
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study