Paper Versus Cartoon Video-based Administration of Study Information Notice for Participant Consent (CONSENT)

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Sponsor:
Elizabeth Glaser Pediatric AIDS Foundation
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Elizabeth Glaser Pediatric AIDS Foundation

Study Description
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Brief Summary:
This study is a randomized trial in which participants are assigned to one of 2 strategies of information notice administration which include the standard approach versus a video-based cartoon approach. An information notice about the study will be administered to each participant individually. The study involves the integration of tuberculosis screening at all pediatric entry points, and other activities aimed at improving pediatric tuberculosis diagnosis and management. The understanding of participants will be assessed using a test of understanding adapted from the Quality of Informed consent (QIC).

Condition or disease     Intervention/treatment     Phase 
Information Disclosure
Other: Cartoon video describing study information notice
Not Applicable

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Study Design
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Study Type  :
Interventional
Estimated Enrollment  :
346 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparing Novel Methods of Study Information Notice Administration to the Standard Approach in Enhancing Clinical Studies Understanding in Resource Limited Settings: A Randomized Trial
Actual Study Start Date  :
March 28, 2022
Actual Primary Completion Date  :
June 30, 2022
Estimated Study Completion Date  :
August 2022
Arms and Interventions
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Arm     Intervention/treatment 
No Intervention: Standard administration of information notice
: During the standard study information administration, the participant will read though the written information notice which will be organized in sections. After each section, the study staff will explain to the participant the key information to understand. Throughout the process, participants will be allowed to ask study staff questions. We anticipate the time to administer consent by this standard approach will be approximately 45 to 60 minutes per participants.
Experimental: video administration of information notice
The video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers.
Other: Cartoon video describing study information notice
The video will be 20-minutes long, and will consist of graphic depictions (in cartoon style) of the study information content presented in the same flow as the written notice, and explained by a voice-over in the background. The participant will view the video in a quiet room, on a tablet provided by the study staff. The participant will be able to pause the video or rewind it as needed, and view it at his/her desired pace. The video will have an embedded knowledge check at the end of each section, consisting of a background voice asking some questions, pausing (for the participant to think through the correct answers) and then providing the right answers.

Outcome Measures
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Primary Outcome Measures  :
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy. [ Time Frame: 1 day ]
The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.

Ages Eligible for Study:  
15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:  
All
Accepts Healthy Volunteers:  
Yes
Criteria
Inclusion Criteria:

All adults > = 21 years of age, or emancipated minors (persons between 15-17 years who are married or pregnant/have children or head of a household)
Are able to speak, read and write English or French
Bringing their children for routine consultation or immunization in the selected study sites
Give their written consent to take part to the study
Exclusion Criteria:

- Participants with visual or hearing challenges which prevent them from reading written forms or viewing/listening to a video content will be excluded Selection of participants

Contacts
Contact: Boris K Tchounga, MD, PhD    690564236 ext 00237    btchounga@pedaids.org    
Contact: Boris Y Tchakounté, MD, MPH    690909743 ext 00237    btchakounte@pedaids.org    

Locations
Cameroon
HD SOA    Recruiting
Yaoundé, Centre, Cameroon
Contact: Merveille Ngapong, Bach       mngapong-consultant@pedaids.org   
Sponsors and Collaborators
Elizabeth Glaser Pediatric AIDS Foundation
Johnson & Johnson
Investigators
Principal Investigator:    Boris K Tchounga, MD, PhD

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