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Identification to Elimination in HCV-Infected Individuals

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03195205
Enrollment
3051
Registered
2017-06-22
Start date
2017-06-01
Completion date
2020-04-20
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

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) 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

Interventions

HCV Screening

Sponsors

Gilead Sciences
CollaboratorINDUSTRY
TruCare Internal Medicine & Infectious Disease
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Positivity rates20 - 40 minutesThe study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.

Secondary

MeasureTime frameDescription
Linked to care1 - 3 monthsThe study will measure the percentage of patients identified as reactive that follow up by linking to care.
Treatment8 - 24 weeksThe study will measure the percentage of patients linked to care who complete treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026