Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
- Conditions
- Healthy
- Registration Number
- NCT02139566
- Lead Sponsor
- Emory University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2405
- ages 18-34
- have had sex with another man in the past 12 months
- female, transgender
- younger than 18 years old
- older than 34 years old
- have not had sex with a man in the past 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Knowledge of Consent Information 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.
- Secondary Outcome Measures
Name Time Method Engagement with Consent Information Time of consent We will measure engagement with the consent information by recording the amount of time a participant spends on the consent page before clicking to the first page of the survey.
Proportion of eligible men who consent Time of informed consent (baseline) The proportion of eligible men who consent to participate in the study; this secondary outcome is applicable only to the randomized study of alternative forms of informed consent administration.
Trial Locations
- Locations (1)
Rollins School of Public Health, Emory University
🇺🇸Atlanta, Georgia, United States
Rollins School of Public Health, Emory University🇺🇸Atlanta, Georgia, United States