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OpenTrials
Completed

NCT Number: NCT03195205

Identification to Elimination in HCV-Infected Individuals

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

TruCare Internal Medicine & Infectious Diseases

DuBois, Pennsylvania, 15801, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OraQuick HCV Rapid Antibody Test

Diagnostic Test

HCV Screening

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

TruCare Internal Medicine & Infectious Disease

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2017
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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