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临床试验/NCT01861210
NCT01861210已完成不适用

Couples HIV Counseling and Testing for Male Couples in the United States

Emory University2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2010年9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
216
试验地点
2
主要终点
Intimate partner violence

研究概览

简要总结

This is a study to determine whether testing for HIV together as a couple, as opposed to testing separately, in acceptable to men in male couples, and is a safe prevention service. Testing of couples together has been provided for decades in Africa, but has never been tested in the United States. In this study, male couples will be enrolled and randomly assigned to be tested together in the same room, or separately. At the time of testing, investigators will ask questions about how they felt about the service they received. Three months later, investigators will survey the men again, and determine whether they had any problems after the testing, like violence in the relationship or the relationship breaking up. The main outcomes are being satisfied with the testing service, and safety (lack of intimate partner violence or relationship termination). Although the study is not designed to determine if the service reduces risk behaviors for HIV transmission, investigators will examine data on risks just to explore that topic. The main hypotheses are: (1) men will be at least as satisfied with couples testing as they are with individual testing; and (2) men tested as couples will not experience higher rates of intimate partner violence or relationship dissolution, relative to men tested separately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • male at birth
  • currently self-identify as male
  • at least 18 years of age
  • have been in a couple with a man for at least 3 months
  • willing to complete a follow-up study visit in 3 months
  • able to complete study assessments in English.

排除标准

  • known to be HIV-positive
  • over 39 years of age
  • either partner being unwilling to accept randomization to the couples testing arm
  • either partner planning to move from the Atlanta area within 3 months of the initial study visit
  • either partner reporting a history of intimate partner violence
  • either partner reporting feeling coerced to tested with his partner

结局指标

主要结局

Intimate partner violence

时间窗: 3 months

Having been punched, hit, or kicked by the partner he tested with, injured to the point of feeling physical pain the day after a fight, or inflicting any of these acts on his partner in the preceding three months.

次要结局

  • Relationship dissolution(3 months, or at the time of followup survey)

研究者

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

Patrick S Sullivan

Professor

Emory University

研究点 (2)

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