Identification to Elimination in HCV-Infected Individuals
Primary Purpose
Hepatitis C
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
OraQuick HCV Rapid Antibody Test
Sponsored by

About this trial
This is an interventional diagnostic trial for Hepatitis C
Eligibility Criteria
Inclusion Criteria:
Subjects will be included in the study if the following criteria is met:
- The subject must be an Opioid Substitution Treatment patient.
- 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:
- The subject cannot be or suspected of being pregnant
- The subject cannot be under the age of 18 years.
- No subjects requiring a legally authorized representative will be enrolled
Sites / Locations
- TruCare Internal Medicine & Infectious Diseases
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
High-Risk Patients
Arm Description
OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Outcomes
Primary Outcome Measures
Positivity rates
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
Secondary Outcome Measures
Linked to care
The study will measure the percentage of patients identified as reactive that follow up by linking to care.
Treatment
The study will measure the percentage of patients linked to care who complete treatment.
Full Information
NCT ID
NCT03195205
First Posted
May 31, 2017
Last Updated
July 1, 2020
Sponsor
TruCare Internal Medicine & Infectious Disease
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03195205
Brief Title
Identification to Elimination in HCV-Infected Individuals
Official Title
A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TruCare Internal Medicine & Infectious Disease
Collaborators
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3051 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-Risk Patients
Arm Type
Other
Arm Description
OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Intervention Type
Diagnostic Test
Intervention Name(s)
OraQuick HCV Rapid Antibody Test
Intervention Description
HCV Screening
Primary Outcome Measure Information:
Title
Positivity rates
Description
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
Time Frame
20 - 40 minutes
Secondary Outcome Measure Information:
Title
Linked to care
Description
The study will measure the percentage of patients identified as reactive that follow up by linking to care.
Time Frame
1 - 3 months
Title
Treatment
Description
The study will measure the percentage of patients linked to care who complete treatment.
Time Frame
8 - 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects will be included in the study if the following criteria is met:
The subject must be an Opioid Substitution Treatment patient.
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:
The subject cannot be or suspected of being pregnant
The subject cannot be under the age of 18 years.
No subjects requiring a legally authorized representative will be enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuesdae R Stainbrook, DO, MPH
Organizational Affiliation
Trucare Internals Medicine & Infectious Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
TruCare Internal Medicine & Infectious Diseases
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Identification to Elimination in HCV-Infected Individuals
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