Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 595
- 试验地点
- 6
- 主要终点
- Vaccine Efficacy
研究概览
简要总结
The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Demonstrate evidence of recent injection drug use (injection stigmata),
- •18 years of age or older,
- •Screened for and found susceptible to HBV
- •Able to provide informed consent.
排除标准
- •Evidence of intoxication that prevented provision of informed consent.
结局指标
主要结局
Vaccine Efficacy
时间窗: 8 months from study enrollment
次要结局
- Vaccine completion rate(8 months from study enrollment)
- Association of exchange status with completion(8 months from study enrollment)
