Improving Consent and Survey Procedures for Young MSM in Web-based HIV Prevention
2 other identifiers
interventional
2,405
1 country
1
Brief Summary
A two-part study to test the efficacy of alternative consent procedures and the efficacy of alternative methods to improve survey completion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jul 2014
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2014
CompletedFirst Posted
Study publicly available on registry
May 15, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 15, 2016
January 1, 2016
10 months
May 11, 2014
January 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Knowledge of Consent Information
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.
At baseline (time zero)
Secondary Outcomes (2)
Proportion of eligible men who consent
Time of informed consent (baseline)
Engagement with Consent Information
Time of consent
Study Arms (4)
Hi-tech video consent
EXPERIMENTALThis 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.
Low-tech video consent
EXPERIMENTALParticipants 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.
FAQ consent
EXPERIMENTALParticipants 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
Standard consent process
ACTIVE COMPARATORParticipants 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- ages 18-34
- have had sex with another man in the past 12 months
You may not qualify if:
- female, transgender
- younger than 18 years old
- older than 34 years old
- have not had sex with a man in the past 12 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rollins School of Public Health, Emory University
Atlanta, Georgia, 30322, United States
Related Publications (2)
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.
PMID: 30381466DERIVEDHall 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.
PMID: 28264794DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick S Sullivan, PhD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2014
First Posted
May 15, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
September 1, 2015
Last Updated
January 15, 2016
Record last verified: 2016-01