Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
Condition: Healthy
Study type: Interventional

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

Detailed description: 
      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.
    

Intervention name(s): Video consent (high-tech); Video consent (low-tech); FAQ format consent; Standard consent; PDF informed consent document
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Consent provided by an animated video with captions; This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.; This consent modality will present the basic information from the informed consent in an interactive, "frequently asked questions" format. Upon clicking each question, the participant will be shown a short text response to that question.; The standard consent form will present the full informed consent document in a scrolling text window within the browser window. Participants will be asked to review the document online.; A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)