Preventing Bacterial and Viral Infections Among Injection Drug Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 3
- 主要终点
- high-risk behavior
研究概览
简要总结
We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission
- •have injected heroin, cocaine, or meth for at least three months
- •positive urine screen for heroin, cocaine, or meth
排除标准
- •currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal
- •cannot provide informed consent
- •not able to complete interviews in English (expected to exclude <5% of IDUs)
- •in police custody, expecting incarceration
- •unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes
- •plan to move out of the Boston area in the next 12 months.
结局指标
主要结局
high-risk behavior
时间窗: one year
health service use
时间窗: one year
bacterial infections
时间窗: one year
次要结局
未报告次要终点
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital