A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 3,051
- Locations
- 2
- Primary Endpoint
- Positivity rates
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Positivity rates
Time Frame: 20 - 40 minutes
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
Secondary Outcomes
- Treatment(8 - 24 weeks)
- Linked to care(1 - 3 months)
Investigators
Tuesdae Stainbrook, DO, MPH
Principal Investigator
TruCare Internal Medicine & Infectious Disease