Clinical trial NCT03195205: Identification to Elimination in HCV-Infected Individuals
Official title: A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatitis C
Lead sponsor: TruCare Internal Medicine & Infectious Disease
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2017-06-22
Enrollment: 3051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility 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

Primary outcomes:
measure: Positivity rates
timeFrame: 20 - 40 minutes
Secondary outcomes:
measure: Linked to care
timeFrame: 1 - 3 months
measure: Treatment
timeFrame: 8 - 24 weeks
Other outcomes:
Locations:
city: DuBois
country: United States
facility: TruCare Internal Medicine & Infectious Diseases
state: Pennsylvania
Study officials:
affiliation: Trucare Internals Medicine & Infectious Disease
name: Tuesdae R Stainbrook, DO, MPH
role: PRINCIPAL_INVESTIGATOR
References: