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临床试验/NCT01161446
NCT01161446已完成不适用

Comparisons of Public Health Screening Methods for Acute and Early HIV Infection: Home Self-Testing for HIV Infection

University of Washington2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2010年7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
230
试验地点
2
主要终点
HIV Testing Frequency

研究概览

简要总结

The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.

详细描述

HIV counseling and testing remains one of the most effective HIV prevention interventions because many individuals newly diagnosed with HIV infection will alter their behaviors to reduce the risk of HIV transmission to others. In the U.S., men who have sex with men (MSM) represent the group with the greatest risk for HIV acquisition despite a high penetrance of testing, in part because their frequent exposures and infrequent testing can result in long intervals between HIV acquisition and diagnosis. Efforts to prevent HIV transmission among MSM must therefore increase the frequency of HIV testing and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. Home self-testing for HIV may increase the frequency of HIV testing, but there are concerns that it may also have negative consequences, including decreased access to risk reduction counseling.

We will randomize 246 MSM at high risk of HIV acquisition either to have access to home self-testing for HIV using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test or to standard, clinic-based HIV testing for 15 months to determine the effects of home self-testing availability on HIV testing frequency and markers of risk for HIV acquisition and to assess the acceptability and ease of use of home self-testing. After screening to determine eligibility, study visits will occur at baseline and at 15 months. Both visits will include HIV/STD screening and surveys regarding HIV testing and risk behaviors. During follow-up, participants will be asked to complete brief online surveys after testing for HIV.

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
None

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

  • Has sex with men
  • HIV-negative
  • Meets PHSKC HIV/STD Program definition of "high risk"
  • Plans to live in Seattle for the next 15 months

排除标准

  • Unable to safely and confidentially receive or store a home testing kit

结局指标

主要结局

HIV Testing Frequency

时间窗: 15 months

Number of HIV tests during follow-up reported by participants at end-of-study visit

次要结局

  • Bacterial Sexually Transmitted Infections(Assessed at 15 months)
  • Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months(From 6 to 9 months and 12 to 15 months of follow-up)
  • Number of Male Condomless Anal Intercourse Partners in Last 3 Months(From 6 to 9 and 12 to 15 months)

研究者

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

Joanne Stekler

Assistant Professor, Division of Allergy & Infectious Diseases

University of Washington

研究点 (2)

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