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临床试验/NCT02139566
NCT02139566已完成不适用

Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention

Emory University1 个研究点 分布在 1 个国家目标入组 2,405 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,405
试验地点
1
主要终点
Knowledge of Consent Information

研究概览

简要总结

A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.

详细描述

Men who have sex with men are the risk population most heavily impacted by HIV in the United States by any measure; in 2009, at least 61% of new HIV infections were estimated to have occurred in MSM. MSM are experiencing an increase in HIV transmission that has been occurring since at least 1990, and accelerated in multiple North American and European countries from 2000-2005. The expansion of the HIV epidemic has been proposed to be attributable, in part, to the extent to which the internet has facilitated sexual connectivity among MSM.

Researchers have attempted to reach MSM for HIV prevention research and intervention on the internet. In the past 10 years, there has been a proliferation of internet surveys and HIV research studies among men who have sex with men that utilize the internet for data collection and, in some cases, the delivery of HIV prevention content. The development of internet-based interventions has been recently identified as especially promising because of its potential for scalability. However, there are also important limitations to internet-based data collections and prevention studies. The most important of these relate to representativeness and opportunities to introduce bias to data collections and differences in access to and use of internet among different subgroups of MSM. Equally important, although less discussed, are the unique ethical and human research protections challenges posed by online sexual health prevention studies.

The investigators will conduct a series of experiments that will result in improved knowledge of how to conduct internet-based HIV prevention research with MSM in ways that improve the protection of human subjects and decrease biases in data collections. The design will consist of preparatory online qualitative research with up to 100 MSM, followed by two cross-sectional randomized controlled trials of MSM recruited online; a total of 2440 MSM will be enrolled in the two randomized quantitative studies (1,440 in Study 1 to determine optimal methods to provide informed consent, online, and 1000 in Study 2 to determine how to best improve retention in online surveys). About 2440 men will be enrolled in the study in total. This summary describes Study 1; a separate submission will be completed for Study 2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 34 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •ages 18-34
  • •have had sex with another man in the past 12 months

排除标准

  • •female, transgender
  • •younger than 18 years old
  • •older than 34 years old
  • •have not had sex with a man in the past 12 months

研究组 & 干预措施

Hi-tech video consent

Experimental

This group will be shown a professionally animated video that presents the major components of the informed consent document. Intervention is Video Consent (high-tech) PDF informed consent document.

干预措施: Video consent (high-tech) (Behavioral)

Hi-tech video consent

Experimental

This group will be shown a professionally animated video that presents the major components of the informed consent document. Intervention is Video Consent (high-tech) PDF informed consent document.

干预措施: PDF informed consent document (Behavioral)

Low-tech video consent

Experimental

Participants in this arm will be provided with informed consent information through viewing a "talking head" video produced by a non-professional presenter, with widely available and inexpensive video equipment. Intervention is "video consent (low-tech)", PDF informed consent document.

干预措施: Video consent (low-tech) (Behavioral)

Low-tech video consent

Experimental

Participants in this arm will be provided with informed consent information through viewing a "talking head" video produced by a non-professional presenter, with widely available and inexpensive video equipment. Intervention is "video consent (low-tech)", PDF informed consent document.

干预措施: PDF informed consent document (Behavioral)

FAQ consent

Experimental

Participants in this arm will be provided with informed consent content through an interactive "frequently asked questions" format, in which the participant will click on a question and be shown text that provides an answer to that question. Major informed consent topics will have one or more question and answer pairs. Intervention is "FAQ format consent", PDF informed consent document

干预措施: FAQ format consent (Behavioral)

FAQ consent

Experimental

Participants in this arm will be provided with informed consent content through an interactive "frequently asked questions" format, in which the participant will click on a question and be shown text that provides an answer to that question. Major informed consent topics will have one or more question and answer pairs. Intervention is "FAQ format consent", PDF informed consent document

干预措施: PDF informed consent document (Behavioral)

Standard consent process

Active Comparator

Participants in this arm will be provided with informed consent content by being shown a standard informed consent document in a scrolling window within the browser window, PDF informed consent document

干预措施: Standard consent (Behavioral)

Standard consent process

Active Comparator

Participants in this arm will be provided with informed consent content by being shown a standard informed consent document in a scrolling window within the browser window, PDF informed consent document

干预措施: PDF informed consent document (Behavioral)

结局指标

主要结局

Knowledge of Consent Information

时间窗: At baseline (time zero)

Correct knowledge of key aspects of the consent document will be operationalized by a count of the correctly answered consent recall items placed at the end of the survey, expressed as the number of correct items as a continuous measure.

次要结局

  • Engagement with Consent Information(Time of consent)
  • Proportion of eligible men who consent(Time of informed consent (baseline))

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 (1)

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