NCT03195205

Identification to Elimination in HCV-Infected Individuals

A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 3,051 (actual)
• Sponsor: TruCare Internal Medicine & Infectious Disease · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Approximately 3.5 - 5 million Americans are living with hepatitis C virus (HCV) in the United States. HCV significantly impacts rural Pennsylvania. It is estimated that 160,000 adults in Pennsylvania are living with hepatitis C. In 2010, Center for Rural Pennsylvania estimated that 27% of population of PA live in one of Pennsylvania's 48 rural counties. Under this estimate, there are over 43,000 individuals affected with chronic HCV living in rural Pennsylvania. Rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs. RQ1: Will the community based delivery system for Hepatitis C screenings see an increase in positivity rates? HO1: There is no relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates. HA1: There is a relationship between the community based delivery system with an increase in the Hepatitis C screening positivity rates.

Detailed description

In rural Pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. Using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations. It is estimated that 35% to 65% of Opioid Substitution Treatment Patients (OST), are infected with HCV. Therefore, OPT programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. In addition, high volume venues attracting high-risk populations will also be targeted to encourage HCV screening, education, and treatment. Primary Objectives: To screen Opioid Substitution Treatment Patients (OST), high-risk individual at Opioid Treatment Programs (OTP), and/or all high-risk populations in outlying sites (Anti-HCV prevalence) To initiate HCV treatment of OST patients and other high-risk individuals at OTP facilities and/or high risk populations in outlying sites (linkage of care) To maintain the successful HCV therapy and cure \[Sustained Viral Response (SVR)\] in OST patients and other high-risk individuals at OPT facility and/or high risk populations in outlying sites (retention) To facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	OraQuick HCV Rapid Antibody Test	HCV Screening

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-04-20
• Completion: 2020-04-20
• First posted: 2017-06-22
• Last updated: 2020-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study