跳至主要内容
临床试验/NCT01174654
NCT01174654已完成1 期

Development of a Methamphetamine Early Intervention

University of Washington2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2006年12月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
127
试验地点
2
主要终点
Non-concordant unprotected anal intercourse

研究概览

简要总结

Methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident HIV in men who have sex with men (MSM), and some authorities have advocated methamphetamine treatment as an HIV prevention strategy. However, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. This application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among MSM for use as an early intervention among MSM in Seattle, Washington. Sixty methamphetamine-using MSM will be enrolled in a randomized controlled trial of contingency management (CM) versus no intervention. CM participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. All participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. Participants will be tested for HIV, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. The study will determine how often MSM will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. Study results will determine the feasibility of instituting and studying CM as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Anal sex with another man in the month prior to enrollment
  • Use of methamphetamine on at least 2 days in the month prior to enrollment

排除标准

  • Plans to move from the study catchment area within 6 months of enrollment
  • A mutually monogamous relationships with a man of the same HIV status lasting 2 or more years

结局指标

主要结局

Non-concordant unprotected anal intercourse

时间窗: Baseline, 6, 12, 18, 24 weeks

次要结局

  • Number of non-concordant unprotected anal intercourse partners(Baseline, 6, 12, 18, 24 weeks)
  • Stimulant (methamphetamine and crack/cocaine) urinalyses(Baseline, 6, 12, 18, 24 weeks)
  • Self-reported methamphetamine use(Baseline, 6, 12, 18, 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验