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

Identification to Elimination in HCV-Infected Individuals

Sponsors

Lead sponsor: TruCare Internal Medicine & Infectious Disease

Collaborator: Gilead Sciences

Source TruCare Internal Medicine & Infectious Disease
Brief 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

Overall Status Completed
Start Date June 1, 2017
Completion Date April 20, 2020
Primary Completion Date April 20, 2020
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Positivity rates 20 - 40 minutes
Secondary Outcome
Measure Time Frame
Linked to care 1 - 3 months
Treatment 8 - 24 weeks
Enrollment 3051
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: OraQuick HCV Rapid Antibody Test

Description: HCV Screening

Arm group label: High-Risk Patients

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Tuesdae R Stainbrook, DO, MPH Principal Investigator Trucare Internals Medicine & Infectious Disease
Location
facility TruCare Internal Medicine & Infectious Diseases
Location Countries

United States

Verification Date

July 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: TruCare Internal Medicine & Infectious Disease

Investigator full name: Tuesdae Stainbrook, DO, MPH

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: High-Risk Patients

Arm group type: Other

Description: OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations

Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov