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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02139566
Enrollment
2405
Registered
2014-05-15
Start date
2014-07-31
Completion date
2015-09-30
Last updated
2016-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BEHAVIORALVideo consent (high-tech)

Consent provided by an animated video with captions

BEHAVIORALVideo consent (low-tech)

This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.

BEHAVIORALFAQ 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.

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.

BEHAVIORALPDF 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.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 34 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of Consent InformationAt 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

MeasureTime frameDescription
Proportion of eligible men who consentTime 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.
Engagement with Consent InformationTime of consentWe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026