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临床试验/NCT01650675
NCT01650675已完成2 期

Indirect Assessment and Intervention for Perinatal Drug Use

Wayne State University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
500
试验地点
2
主要终点
Change from Baseline HIV and other STI risk at 3 months

研究概览

简要总结

The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period.

详细描述

Two factors limit the potential of brief interventions for the reduction of substance abuse and HIV risk. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use and risky sexual behaviors. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to time, training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed and validated a sensitive indirect screener that evaluates correlates of illicit drug use rather than drug use itself. The Lab also developed a brief computer-delivered intervention designed to build change motivation without presuming the presence of risks to accompany the screener. This intervention demonstrated excellent feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. In addition, given that 47.8% of the prior sample's participants had an STI at some point in their lives, the proposed study will also further expand the existing focus on HIV risk. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples, as well as by building its ability to indirectly predict HIV risk; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years of age or older
  • able to communicate in English
  • recently gave birth to healthy infant

排除标准

  • received narcotic pain medication in past 3 hours
  • no sleep since giving birth
  • infant deceased or in intensive care
  • psychosis or other clear cognitive impairment

结局指标

主要结局

Change from Baseline HIV and other STI risk at 3 months

时间窗: since last research visit; up to 90 days from baseline visit

Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs

Change from Baseline in HIV and Other STI Risk at 6 months

时间窗: since last research visit; up to 180 days since baseline visit

Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs

Number of drug using days

时间窗: since last research visit; up to 90 days prior to current evaluation

Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven J. Ondersma

Associate Professor

Wayne State University

研究点 (2)

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