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

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Emory University

Status

Completed

Conditions

Healthy

Treatments

Behavioral: Video consent (low-tech)
Behavioral: Standard consent
Behavioral: Video consent (high-tech)
Behavioral: FAQ format consent
Behavioral: PDF informed consent document

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02139566
IRB00065333
1R21HD074502-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

2,405 patients

Sex

Male

Ages

18 to 34 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

2,405 participants in 4 patient groups

Hi-tech video consent
Experimental group
Description:
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.
Treatment:
Behavioral: PDF informed consent document
Behavioral: Video consent (high-tech)
Low-tech video consent
Experimental group
Description:
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.
Treatment:
Behavioral: PDF informed consent document
Behavioral: Video consent (low-tech)
FAQ consent
Experimental group
Description:
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
Treatment:
Behavioral: PDF informed consent document
Behavioral: FAQ format consent
Standard consent process
Active Comparator group
Description:
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
Treatment:
Behavioral: PDF informed consent document
Behavioral: Standard consent

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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