Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 502
- 试验地点
- 2
- 主要终点
- Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
研究概览
简要总结
There is a need to identify and test effective strategies to reduce meth use and human immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the investigators are testing to determine if the investigators can enhance this standard. The specific aims and hypotheses of this protocol are:
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use, specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM (which will have more reduction than HIV T/C), potentially mediated through increased service utilization.
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors than those in CM (which will have greater decreases than HIV T/C), potentially mediated through reduced drug use.
- To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health status than those in CM (which will have greater improvements than HIV T/C), potentially mediated through increased service utilization and reduction of drug use, and potentially moderated by baseline meth use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •18 years of age or older
- •Be competent (not too intoxicated or mentally disabled) to give informed consent at the time of the interview
- •Meth use (verified through urine drug screening and a self-report of meth use of at least 4 times per month for the last 3 months)
- •Self-reported sex with someone of the opposite sex in last 30 days
- •Ability to provide a reliable address and phone number for contact
- •Not in drug treatment in the past 30 days
- •Willingness to be tested for HIV at baseline and follow-up
- •Not transient and no know reason why he/she will not be available for follow-up interviews
- •Not currently mandated by the criminal justice system to receive treatment based on self-report.
排除标准
- •Participation in drug treatment in the past 30 days
- •Currently participating in another Project Safe study
- •Pregnant or attempting to become pregnant
- •Intoxicated or impaired mentally to the point that they cannot voluntarily consent to participate tin the project and/or respond to the interview
结局指标
主要结局
Reduction of HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users
时间窗: 12-month follow-up interview
Improved mental health status
时间窗: 12-month follow-up interview
Reduction of drug use, specifically methamphetamine
时间窗: 12-month follow-up interview
次要结局
未报告次要终点