The purpose of this study is to test an interactive multimedia informed consent (iMIC)
computer program to see if the program can generate a consent form that potential
participants in an HIV trial can understand. This study will also determine if these
participants prefer the computer-generated consent form and associated interactive tools to
a standard consent form written by researchers.
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.
Researchers conducting clinical trials have a legal and ethical obligation to provide
participants key information about the trial so that they may either decline participation
or grant their informed consent to participate in the study. However, information provided
to prospective clinical trial participants is often complex and confusing; often, language
used in informed consent is written far above participants' reading level. This study will
evaluate the usefulness of a consent form authoring system that helps researchers write
comprehensive and understandable consent forms; the authoring system produces both paper
consent forms and interactive computer tutorials that are designed to teach potential
volunteers about the research study they are considering. This study will compare
iMIC-generated consent forms and computer tutorials with standard consent forms for two mock
HIV studies: a vaccine trial (VT) and an antiretroviral drug trial (AT).
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.
- HIV-infected OR at risk for HIV infection
- Able to read English at the 5th grade level