Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in sexual risk
研究概览
简要总结
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.
详细描述
- To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period.
- To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or older
- •Self-reports as a man who has sex with men
- •HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
- •Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
- •Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months
排除标准
- •Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- •Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
- •Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
结局指标
主要结局
Change in sexual risk
时间窗: Baseline and three months post-treatment; baseline and six months post-treatment
We will ask about number of unprotected and protected insertive and receptive anal, vaginal and oral sex acts with male and female sex partners separately for HIV seropositive, seronegative, and partners of unknown HIV status with questions from measures used in previous studies. We will use this to calculate the ratio of protected to unprotected acts, by serostatus partner, and by whether or not crystal meth was being used before or during sex. Baseline and three and six-month follow-up assessments will assess sexual risk taking in the previous 3-months to the assessment being completed.
次要结局
- Change in crystal methamphetamine use(Baseline and three months post-treatment; baseline and six months post-treatment)
研究者
Matthew James Mimiaga
Assistant Professor
Massachusetts General Hospital