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

NCT ID: NCT04235049

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-10-30

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.

Conditions

HCV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Community Linkage - Rapid Initiation Arm

The rapid initiation group will receive HCV medication immediately upon release from prison/jail.

Group Type: ACTIVE_COMPARATOR

Glecaprevir/pibrentasvir

Intervention Type: DRUG

Treatment for HCV Infection

Community Linkage - Clinic-Based Initiation Arm

The group will receive medication after attending first ANCHOR clinic visit.

Group Type: ACTIVE_COMPARATOR

Glecaprevir/pibrentasvir

Intervention Type: DRUG

Treatment for HCV Infection

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Glecaprevir/pibrentasvir

Treatment for HCV Infection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age greater than or equal to 18 years old

2. Able and willing to sign informed consent

3. For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater).

4. For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date

5. For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC

Exclusion Criteria

1. Decompensated cirrhosis (Child-Pugh B or C)

2. Pregnant or breastfeeding women

3. For community linkage arm: Prior treatment with a direct acting antiviral regimen

4. For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir

5. Poor venous access not allowing screening laboratory collection

6. Have any condition that the investigator considers a contraindication to study participation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Maryland Department of Public Safety and Correctional Services

UNKNOWN

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Elana Rosenthal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elana Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Baltimore City Detention Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00088498

Identifier Type: -

Identifier Source: org_study_id