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临床试验/NCT01840722
NCT01840722已完成不适用

Brief Intervention for Rural Women at High Risk for HIV/HCV

Michele Staton2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
试验地点
2
主要终点
Number of Participants Having Unprotected Casual Sex

研究概览

简要总结

The overall aim of this study is to reduce risk behaviors and increase health and behavioral health service utilization among disadvantaged, drug-using rural women at high risk for HIV and HCV. This project has potential to make a significant contribution to science by providing knowledge about the health, risk behaviors, and service utilization of a vulnerable and understudied group of women during a time of emerging and significant public health risk in a rural Appalachian setting. Successful completion of the aims of this project will advance the delivery of a low-cost, potentially high impact intervention with implications for a number of other real world settings (such as criminal justice venues) where other disadvantaged high-risk drug users can be identified and targeted for intervention.

详细描述

Specific Aim 1: Compare the effectiveness of an evidence-based HIV risk reduction intervention (MI-HIV) to HIV Education (NIDA Standard) in reducing sex risk behaviors, injection practices, and drug use among a culturally unique sample of disadvantaged, drug-using rural women at high-risk for HIV and HCV. This aim will be accomplished through the random selection of high-risk rural women drug users from rural jails, screening and assessment for high-risk behavior, and random assignment to the HIV-Ed or MI-HIV intervention conditions. Follow-up interviews at 3, 6, and 12 months in the community post-release will examine changes in high-risk behavior. It is expected that MI-HIV participants will report significantly greater reductions in risky injection drug use practices, other drug use, and sex risk behaviors than women who participate in the HIV-Ed condition.

Specific Aim 2: Examine MI-HIV Intervention engagement as a predictor of community health and behavioral health service utilization (including drug treatment and mental health) at follow-up among disadvantaged, drug-using rural women at high risk for HIV and HCV. This aim will focus on community service utilization during the follow-up period by the intervention and education comparison group, and how health and behavioral health service utilization relates to patterns of HIV/HCV risk behavior. It is expected that MI-HIV participants will utilize more services due to increased motivation for treatment and treatment planning following the brief intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • ASSIST score of 4+
  • engagement in at least one sex risk behavior in the past 3 months
  • willingness to participate in brief intervention sessions
  • no evidence of cognitive impairment
  • no evidence of active psychosis (currently experiencing hallucinations)
  • no self-reported current symptoms of physical withdrawal from a recent episode of drug use
  • incarceration period of 1 week - 3 months in order to complete intervention sessions

排除标准

  • ASSIST score of <4
  • no engagement in at least one sex risk behavior in the past 3 months
  • not willing to participate in brief intervention sessions
  • evidence of cognitive impairment
  • evidence of active psychosis (currently experiencing hallucinations)
  • self-reported current symptoms of physical withdrawal from a recent episode of drug use
  • incarceration period of less than 1 week or greater than 3 months in order to complete intervention sessions

研究组 & 干预措施

NIDA Standard HIV Education

No Intervention

NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources

MI-based HIV Risk Reduction

Experimental

MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.

干预措施: MI-based HIV Risk Reduction (Other)

结局指标

主要结局

Number of Participants Having Unprotected Casual Sex

时间窗: 6 months

Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months

次要结局

  • Number of Participants Exchanging Sex(6 months)
  • Number of Participants Recently Receiving Physical or Behavioral Health Treatment(6 months)

研究者

发起方
Michele Staton
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michele Staton

Associate Professor

University of Kentucky

研究点 (2)

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