HIV InfectionsNCT00104559
Computer-Generated Vs. Standard Informed Consent for HIV Research Studies
A study testing iMIC-generated consent form and tutorial and Standard paper consent form in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- iMIC-generated consent form and tutorial and Standard paper consent form
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infected OR at risk for HIV infection
- Able to read English at the 5th grade level
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interactive Multimedia Informed Consent (iMIC) for HIV Research
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- iMIC-generated consent form and tutorial, Standard paper consent form
- Keywords
- HIV, Informed Consent
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMIC-generated consent form and tutorialBehavioural
Computer-based consent form and tutorial
Standard paper consent formBehavioural
Standard paper consent form
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive the computer-based tutorial for VT and then the standard paper consent form for AT Receives: Behavioral: iMIC-generated consent form and tutorial; Behavioral: Standard paper consent form |
| 2 | Experimental | Participants will receive the standard paper consent form for VT and then the computer-based tutorial for AT Receives: Behavioral: iMIC-generated consent form and tutorial; Behavioral: Standard paper consent form |
| 3 | Experimental | Participants will receive the computer-based tutorial for AT and then the standard paper consent form for VT Receives: Behavioral: iMIC-generated consent form and tutorial; Behavioral: Standard paper consent form |
| 4 | Experimental | Participants will receive the standard paper consent form for AT and then the computer-based tutorial for VT Receives: Behavioral: iMIC-generated consent form and tutorial; Behavioral: Standard paper consent form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical trial knowledge acquisition
Measured: Throughout study
Consent form usability
Measured: Throughout study
Volunteer satisfaction
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2005 (estimated)
- Study startJan 2005
- Primary completionJul 2007 (estimated)
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Brian D. Raffety, PhD, Principal investigator, The Circumplex Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104559
- Sponsor's protocol ID
- 1R43AI058870-01
- Other IDs
- 1R43AI058870-01
- Status last verified
- Sep 2008
- First submitted
- 1 Mar 2005
- Last updated
- 26 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Multimedia Informed Consent (iMIC) for HIV Research
- ClinicalTrials.gov ID
- NCT00104559
- Acronym / sponsor ID
- 1R43AI058870-01
- Conditions
- HIV Infections
- Keywords
- HIV, Informed Consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (estimated)
- Study completion
- Mar 2009 (estimated)
- First posted
- 2 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: iMIC-generated consent form and tutorial, Behavioral: Standard paper consent formParticipants will receive the computer-based tutorial for VT and then the standard paper consent form for AT |
| 2 | Experimental | Behavioral: iMIC-generated consent form and tutorial, Behavioral: Standard paper consent formParticipants will receive the standard paper consent form for VT and then the computer-based tutorial for AT |
| 3 | Experimental | Behavioral: iMIC-generated consent form and tutorial, Behavioral: Standard paper consent formParticipants will receive the computer-based tutorial for AT and then the standard paper consent form for VT |
| 4 | Experimental | Behavioral: iMIC-generated consent form and tutorial, Behavioral: Standard paper consent formParticipants will receive the standard paper consent form for AT and then the computer-based tutorial for VT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-infected OR at risk for HIV infection
- Able to read English at the 5th grade level
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iMIC-generated consent form and tutorialComputer-based consent form and tutorial | Behavioural | 1, 2, 3, 4 |
| Standard paper consent formStandard paper consent form | Behavioural | 1, 2, 3, 4 |
Primary outcome
Clinical trial knowledge acquisition
Time frame: Throughout study
Consent form usability
Time frame: Throughout study
Volunteer satisfaction
Time frame: Throughout study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingEarly Phase 1
A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
Plasmablastic Lymphoma, Ann Arbor Stage I Diffuse Large B-Cell Lymphoma
Active, not recruiting
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
HIV Prevention
Not yet recruiting
Bwelela Easy Study
HIV, HIV - Human Immunodeficiency Virus
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian D. Raffety, PhD principal investigator
The Circumplex Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iMIC-generated consent form and tutorial and Standard paper consent form in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical trial knowledge acquisition (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2008.