Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
NCT ID: NCT02139566
Last Updated: 2016-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2405 participants
INTERVENTIONAL
2014-07-31
2015-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Hi-tech video consent
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.
Video consent (high-tech)
Consent provided by an animated video with captions
PDF informed consent document
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.
Low-tech video consent
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.
Video consent (low-tech)
This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.
PDF informed consent document
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.
FAQ consent
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
FAQ format consent
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.
PDF informed consent document
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.
Standard consent process
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
Standard consent
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.
PDF informed consent document
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.
Interventions
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Video consent (high-tech)
Consent provided by an animated video with captions
Video consent (low-tech)
This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.
FAQ format consent
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.
Standard consent
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.
PDF informed consent document
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.
Eligibility Criteria
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Inclusion Criteria
* have had sex with another man in the past 12 months
Exclusion Criteria
* younger than 18 years old
* older than 34 years old
* have not had sex with a man in the past 12 months
18 Years
34 Years
MALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Emory University
OTHER
Responsible Party
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Patrick S Sullivan
Professor
Principal Investigators
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Patrick S Sullivan, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Rollins School of Public Health, Emory University
Atlanta, Georgia, United States
Countries
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References
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Hall E, Sanchez T, Stephenson R, Stein AD, Sineath RC, Zlotorzynska M, Sullivan P. Randomised controlled trial of incentives to improve online survey completion among internet-using men who have sex with men. J Epidemiol Community Health. 2019 Feb;73(2):156-161. doi: 10.1136/jech-2018-211166. Epub 2018 Oct 31.
Hall EW, Sanchez TH, Stein AD, Stephenson R, Zlotorzynska M, Sineath RC, Sullivan PS. Use of Videos Improves Informed Consent Comprehension in Web-Based Surveys Among Internet-Using Men Who Have Sex With Men: A Randomized Controlled Trial. J Med Internet Res. 2017 Mar 6;19(3):e64. doi: 10.2196/jmir.6710.
Other Identifiers
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IRB00065333
Identifier Type: -
Identifier Source: org_study_id
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