A Novel Approach Continuum to Identification to Elimination in HCV-Infected Individuals on Opioid Substitution Therapy and High-Risk Populations
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,051
- 试验地点
- 2
- 主要终点
- Positivity rates
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Positivity rates
时间窗: 20 - 40 minutes
The study will measure the percentage of patients screened for Hepatitis C who are reactive by detecting HCV antibodies.
次要结局
- Treatment(8 - 24 weeks)
- Linked to care(1 - 3 months)
研究者
Tuesdae Stainbrook, DO, MPH
Principal Investigator
TruCare Internal Medicine & Infectious Disease