NCT00104559

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

2.5 years

First QC Date

March 1, 2005

Last Update Submit

September 25, 2008

Conditions

HIV Infections

Keywords

HIVInformed Consent

Outcome Measures

Primary Outcomes (3)

  • Clinical trial knowledge acquisition

    Throughout study

  • Consent form usability

    Throughout study

  • Volunteer satisfaction

    Throughout study

Study Arms (4)

1

EXPERIMENTAL

Participants will receive the computer-based tutorial for VT and then the standard paper consent form for AT

Behavioral: iMIC-generated consent form and tutorialBehavioral: Standard paper consent form

2

EXPERIMENTAL

Participants will receive the standard paper consent form for VT and then the computer-based tutorial for AT

Behavioral: iMIC-generated consent form and tutorialBehavioral: Standard paper consent form

3

EXPERIMENTAL

Participants will receive the computer-based tutorial for AT and then the standard paper consent form for VT

Behavioral: iMIC-generated consent form and tutorialBehavioral: Standard paper consent form

4

EXPERIMENTAL

Participants will receive the standard paper consent form for AT and then the computer-based tutorial for VT

Behavioral: iMIC-generated consent form and tutorialBehavioral: Standard paper consent form

Interventions

iMIC-generated consent form and tutorialBEHAVIORAL

Computer-based consent form and tutorial

1234
Standard paper consent formBEHAVIORAL

Standard paper consent form

1234

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected OR at risk for HIV infection
  • Able to read English at the 5th grade level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Circumplex Company

Seattle, Washington, 98125, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Brian D. Raffety, PhD

    The Circumplex Company

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 1, 2005

First Posted

March 2, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2007

Study Completion

March 1, 2009

Last Updated

September 26, 2008

Record last verified: 2008-09

Locations

US(1)