Clinical trial NCT04235049: Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)
Official title: Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: HCV Infection
Keywords: HCV infection
Incarcerated individuals
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Maryland Department of Public Safety and Correctional Services
First posted: 2020-01-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sustained Virologic Response (SVR) in the community linkage arm
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Retrospective rates of SVR in the In prison arm
timeFrame: 6 months after treatment
measure: Treatment Initiation Rates
timeFrame: 6 months
measure: OAT uptake Rates
timeFrame: 12 months
measure: HCV Reinfection Rates
timeFrame: 24 months
measure: Comparison between Rapid Initiation and Clinic-base Initiation
timeFrame: 24 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Detention Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Elana Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: