Identification to Elimination in HCV-Infected Individuals
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/29/2018 |
| Start Date: | June 1, 2017 |
| End Date: | June 2020 |
| Contact: | Tuesdae R Stainbrook, DO, MPH |
| Email: | drstainbrook@trucareinternalmedicine.com |
| Phone: | 814-371-2348 |
A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
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.
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.
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
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
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
We found this trial at
1
site
190 West Park Avenue
DuBois, Pennsylvania 15801
DuBois, Pennsylvania 15801
Principal Investigator: Tuesdae R Stainbrook, DO, MPH
Phone: 814-371-2348
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