Computer-Generated Vs. Standard Informed Consent for HIV Research Studies
NCT ID: NCT00104559
Last Updated: 2008-09-26
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2005-01-31
2009-03-31
Brief Summary
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Study hypothesis: 1) Participants who receive information about clinical trials from iMIC Consent Tutorials will answer more questions about the trial correctly than participants who receive information about clinical trials from standard paper consent forms. 2) Participants will rate the iMIC Consent Tutorials as having better usability and user satisfaction than standard paper consent forms.
Detailed Description
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The iMIC software provides researchers a computer-based authoring environment for producing easier-to-understand informed consent documents. iMIC assists researchers by helping them focus on clearly defining consent issues and content goals, including regulatory, legal, and ethical guidelines to be followed. Through tests for readability and other feedback, iMIC ensures that all the content requirements of good informed consent are met. iMIC generates a paper consent form and an interactive multimedia computer tutorial to help volunteers learn about the clinical trial. The paper consent document can be stand alone or used in conjunction with the generated computer tutorial.
Each participant will receive two consent interventions: one computer-based tutorial and one standard paper consent form. Participants will be randomly assigned to one of four groups. Group 1 will receive the computer-based tutorial for VT and then the standard paper consent form for AT. Group 2 will receive the standard paper consent form for VT and then the computer-based tutorial for AT. Group 3 will receive the computer-based tutorial for AT and then the standard paper consent form for VT. Group 4 will receive the standard paper consent form for AT and then the computer-based tutorial for VT.
At the start of the session, participants will be asked demographic questions and will receive the first consent intervention. When they have completed the intervention, they will be asked 15 questions about the key elements of the clinical trial they have just learned about, as well as an additional series of usability and satisfaction questions about the consent intervention. Next, they will receive the second consent intervention that will teach them about the second clinical trial. Again, they will be asked knowledge and usability and satisfaction questions. After completing the second consent intervention, participants will be asked to compare and answer questions about the two methods of receiving information about clinical trials.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Participants will receive the computer-based tutorial for VT and then the standard paper consent form for AT
iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Standard paper consent form
Standard paper consent form
2
Participants will receive the standard paper consent form for VT and then the computer-based tutorial for AT
iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Standard paper consent form
Standard paper consent form
3
Participants will receive the computer-based tutorial for AT and then the standard paper consent form for VT
iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Standard paper consent form
Standard paper consent form
4
Participants will receive the standard paper consent form for AT and then the computer-based tutorial for VT
iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Standard paper consent form
Standard paper consent form
Interventions
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iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Standard paper consent form
Standard paper consent form
Eligibility Criteria
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Inclusion Criteria
* Able to read English at the 5th grade level
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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The Circumplex Company
Principal Investigators
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Brian D. Raffety, PhD
Role: PRINCIPAL_INVESTIGATOR
The Circumplex Company
Locations
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The Circumplex Company
Seattle, Washington, United States
Countries
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