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
1 other identifier
interventional
3,051
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2017
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2020
CompletedJuly 2, 2020
July 1, 2020
2.9 years
May 31, 2017
July 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Positivity rates
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
20 - 40 minutes
Secondary Outcomes (2)
Linked to care
1 - 3 months
Treatment
8 - 24 weeks
Study Arms (1)
High-Risk Patients
OTHEROraQuick HCV screening for HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TruCare Internal Medicine & Infectious Diseaselead
- Gilead Sciencescollaborator
Study Sites (1)
TruCare Internal Medicine & Infectious Diseases
DuBois, Pennsylvania, 15801, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuesdae R Stainbrook, DO, MPH
Trucare Internals Medicine & Infectious Disease
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 22, 2017
Study Start
June 1, 2017
Primary Completion
April 20, 2020
Study Completion
April 20, 2020
Last Updated
July 2, 2020
Record last verified: 2020-07