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Identification to Elimination in HCV-Infected Individuals

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ClinicalTrials.gov Identifier: NCT03195205
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Tuesdae Stainbrook, DO, MPH, 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.


Condition or disease Intervention/treatment Phase
Hepatitis C Diagnostic Test: OraQuick HCV Rapid Antibody Test Early Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
High-Risk Patients
OraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Diagnostic Test: OraQuick HCV Rapid Antibody Test
HCV Screening




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Treatment [ Time Frame: 8 - 24 weeks ]
    The study will measure the percentage of patients linked to care who complete treatment.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Tuesdae R Stainbrook, DO, MPH 814-371-2348 drstainbrook@trucareinternalmedicine.com
Contact: Mary A Simpson, BSAS, MBA 814-371-2348 marysimpson@trucareinternalmedicine.com

Locations
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United States, Pennsylvania
TruCare Internal Medicine & Infectious Diseases Recruiting
DuBois, Pennsylvania, United States, 15801
Contact: Tuesdae R Stainbrook, DO, MPH    814-371-2348    drstainbrook@trucareinternalmedicine.com   
Contact: Mary A Simpson, BSAS, MBA    814-371-2348    marysimpson@trucareinternalmedicine.com   
Principal Investigator: Tuesdae R Stainbrook, DO, MPH         
Sub-Investigator: Kelsey Elliott (Parfitt), PA-C         
Sub-Investigator: Mary A Simpson, BSAS, MBA         
Sponsors and Collaborators
TruCare Internal Medicine & Infectious Disease
Gilead Sciences
Investigators
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Principal Investigator: Tuesdae R Stainbrook, DO, MPH Trucare Internals Medicine & Infectious Disease

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Responsible Party: Tuesdae Stainbrook, DO, MPH, Principal Investigator, TruCare Internal Medicine & Infectious Disease
ClinicalTrials.gov Identifier: NCT03195205     History of Changes
Other Study ID Numbers: GSI-2016-09-APR
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antibodies
Immunologic Factors
Physiological Effects of Drugs