Identification to Elimination in HCV-Infected Individuals

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195205
• Other study ID #: GSI-2016-09-APR
• Status: Completed
• Phase: Early Phase 1
• Start date: June 1, 2017
• Est. completion date: April 20, 2020

Study information

• Verified date: July 2020
• Source: TruCare Internal Medicine & Infectious Disease
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3051
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Subjects will be included in the study if the following criteria is met:

1. The subject must be an Opioid Substitution Treatment patient.

2. The subject must fall into another high-risk population for the HCV.

Exclusion Criteria:

Subjects may be excluded from the study if the subject falls into an exclusion category as identified as:

1. The subject cannot be or suspected of being pregnant

2. The subject cannot be under the age of 18 years.

3. No subjects requiring a legally authorized representative will be enrolled

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Diagnostic Test:
• OraQuick HCV Rapid Antibody Test
HCV Screening

Locations

Country	Name	City	State
United States	TruCare Internal Medicine & Infectious Diseases	DuBois	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
TruCare Internal Medicine & Infectious Disease	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positivity rates	The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.	20 - 40 minutes
Secondary	Linked to care	The study will measure the percentage of patients identified as reactive that follow up by linking to care.	1 - 3 months
Secondary	Treatment	The study will measure the percentage of patients linked to care who complete treatment.	8 - 24 weeks