Identification to Elimination in HCV-Infected Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03195205|
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : September 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C||Diagnostic Test: OraQuick HCV Rapid Antibody Test||Early Phase 1|
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.
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Diagnostic Test: OraQuick HCV Rapid Antibody Test
- 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.
- Linked to care [ Time Frame: 1 - 3 months ]The study will measure the percentage of patients identified as reactive that follow up by linking to care.
- Treatment [ Time Frame: 8 - 24 weeks ]The study will measure the percentage of patients linked to care who complete treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195205
|Contact: Tuesdae R Stainbrook, DO, MPHemail@example.com|
|Contact: Mary A Simpson, BSAS, MBAfirstname.lastname@example.org|
|United States, Pennsylvania|
|TruCare Internal Medicine & Infectious Diseases||Recruiting|
|DuBois, Pennsylvania, United States, 15801|
|Contact: Tuesdae R Stainbrook, DO, MPH 814-371-2348 email@example.com|
|Contact: Mary A Simpson, BSAS, MBA 814-371-2348 firstname.lastname@example.org|
|Principal Investigator: Tuesdae R Stainbrook, DO, MPH|
|Sub-Investigator: Kelsey Elliott (Parfitt), PA-C|
|Sub-Investigator: Mary A Simpson, BSAS, MBA|
|Principal Investigator:||Tuesdae R Stainbrook, DO, MPH||Trucare Internals Medicine & Infectious Disease|