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

Conditions

• HCV Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Glecaprevir/pibrentasvir — DRUG
  Treatment for HCV Infection

Study Details

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.

Key Dates

Start date

Oct 1, 2021

Status verified

Apr 2021

Primary completion

Mar 30, 2022

Completion

Oct 30, 2024

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: In prison treatment arm
  Of patients who achieved SVR, 100 inmates will be enrolled for long-term monitoring for re-infection after they have completed treatment. Patients will be seen every 6 months to test for reinfection, however they will not be subject to any medical or behavioral interventions through the study team. Limited opioid agonist therapy may be available as per the standard practice of the DOC, however syringe exchange and other harm reduction services will not be accessible to inmates, per DOC policy.
• Active Comparator: Community Linkage - Rapid Initiation Arm
  The rapid initiation group will receive HCV medication immediately upon release from prison/jail.
• Active Comparator: Community Linkage - Clinic-Based Initiation Arm
  The group will receive medication after attending first ANCHOR clinic visit.
• No Intervention: In prison - Retrospective Review
  a retrospective review of de-identified available data provided by the DOC for all patients previously treated with DAAs through standard of care in the DOC will be reviewed for rates of SVR.

Primary Outcome Measure

Sustained Virologic Response (SVR) in the community linkage arm [ Time Frame: 6 months after treatment ]

Locations (1)

Find similar trials in Baltimore, MD