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临床试验/NCT00809445
NCT00809445已完成3 期

HIV Rapid Testing and Counseling in Drug Abuse Treatment Programs in the U.S.

University of Miami24 个研究点 分布在 1 个国家目标入组 1,281 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
1,281
试验地点
24
主要终点
Self-Report Receipt of HIV Test Results

研究概览

简要总结

This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.

详细描述

This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • HIV-negative or HIV status unknown
  • No receipt of results from HIV test initiated within last 12 months
  • Be able to communicate in English

排除标准

  • 未提供

结局指标

主要结局

Self-Report Receipt of HIV Test Results

时间窗: One month post-randomization

The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.

Number of Risky Sexual Behaviors

时间窗: Six months post-randomization

The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).

次要结局

  • Sharing of Needles Used in Drug Use(Six months)
  • Self-Report of Ever Having Been Tested(1 month post-randomization)

研究者

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

Daniel J Feaster

Associate Professor of Biostatistics

University of Miami

研究点 (24)

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