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

NCT05341791 | Completed DMC

• 1 other identifier: EG0266
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

Information Disclosure

Outcome Measures

Primary Outcomes (1)

• The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.

  The proportion of participants scoring more than 80% on the test of understanding, comparing the novel and the standard strategy.

  1 day

Study Arms (2)

Standard administration of information notice

NO INTERVENTION

: 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.

video administration of information notice

EXPERIMENTAL

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

Interventions

Cartoon video describing study information notice OTHER

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.

video administration of information notice

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Johnson & Johnson: collaborator

Study Sites (1)

HD SOA

Yaoundé, Centre Region, Cameroon

Location

Study Officials

• Boris K Tchounga, MD, PhD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: March 28, 2022
• Primary Completion: June 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)