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临床试验/NCT01224184
NCT01224184已完成不适用

Adapting the Women's CoOp for At-Risk Teens

RTI International4 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
237
试验地点
4
主要终点
Changes in behaviors, including condom use, substance use and violence prevention

研究概览

简要总结

The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention.

详细描述

This study completed an extensive formative phase to adapt the Women's CoOp intervention to specifically address the needs of young out-of-school adolescent African-American females with regard to knowledge about sexually transmitted infections (STIs), HIV and sexuality, health consequences of substance abuse, relationships with males, condom communication and social support, and HIV risk-reduction and violence prevention methods. During this phase, in-depth interviews, focus groups, pretesting and pilot testing were conducted to adapt and refine the intervention for the clinical trial.

The aim of this trial is to:

• Evaluate the efficacy of the cultural-, age-, and gender-focused intervention (Young Women's CoOp) relative to an equal attention control nutrition intervention in terms of changes in behaviors (e.g., condom use, substance use, violence prevention).

At study enrollment/baseline, participants completed a questionnaire and baseline drug and pregnancy testing, and were randomized into one of two programs: Young Women's CoOp or Staying Healthy and Eating Well (Nutrition)-both which included 3 individual intervention sessions and 1 group activity. Follow-ups were conducted 3-months post-intervention and 6-months post-intervention and included a questionnaire and drug testing.

The study has since been completed and analysis and manuscript preparation is underway. Two abstracts have been accepted to American Public Health Association conferences in 2012 and 2013. The five papers in progress or published include:

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
None

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Black/African-American
  • 16-19 years of age
  • Have dropped out of school at least once or are having problems that they have considered dropping out of school, and have not yet completed high school or GED program
  • Have not graduated from a high school or alternative school, or completed a General Education Development (GED) program
  • Have had vaginal sex at least once in the past 90 days with a male partner
  • Have used one of the following at least once in the past 90 days--alcohol, marijuana, cocaine/crack, heroin, ecstasy, methamphetamine, any prescription drugs not prescribed to them, or any other illicit substance.
  • Will be in the area for the next 8 months
  • Has not participated in previous formative activities of the study (e.g., interviews, focus groups, pretesting and pilot testing),

排除标准

  • Not interested in coming to a health behavior study
  • Not able to attend 4 sessions and 2 follow ups

结局指标

主要结局

Changes in behaviors, including condom use, substance use and violence prevention

时间窗: 3, and 6- months post-intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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