Computer-Generated Vs. Standard Informed Consent for HIV Research Studies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00104559
First received: March 1, 2005
Last updated: September 25, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: iMIC-generated consent form and tutorial
Behavioral: Standard paper consent form

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Interactive Multimedia Informed Consent (iMIC) for HIV Research

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Clinical trial knowledge acquisition [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Consent form usability [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Volunteer satisfaction [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive the computer-based tutorial for VT and then the standard paper consent form for AT
Behavioral: iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Behavioral: Standard paper consent form
Standard paper consent form
Experimental: 2
Participants will receive the standard paper consent form for VT and then the computer-based tutorial for AT
Behavioral: iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Behavioral: Standard paper consent form
Standard paper consent form
Experimental: 3
Participants will receive the computer-based tutorial for AT and then the standard paper consent form for VT
Behavioral: iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Behavioral: Standard paper consent form
Standard paper consent form
Experimental: 4
Participants will receive the standard paper consent form for AT and then the computer-based tutorial for VT
Behavioral: iMIC-generated consent form and tutorial
Computer-based consent form and tutorial
Behavioral: Standard paper consent form
Standard paper consent form

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HIV-infected OR at risk for HIV infection
  • Able to read English at the 5th grade level
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104559

Locations
United States, Washington
The Circumplex Company
Seattle, Washington, United States, 98125
Sponsors and Collaborators
Investigators
Principal Investigator: Brian D. Raffety, PhD The Circumplex Company
  More Information

No publications provided

Responsible Party: Brian D. Raffety, PhD, The Circumplex Company
ClinicalTrials.gov Identifier: NCT00104559     History of Changes
Other Study ID Numbers: 1R43AI058870-01, 1R43-AI058870-01
Study First Received: March 1, 2005
Last Updated: September 25, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV
Informed Consent

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 26, 2014