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

NCT05341791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2023-02-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Elizabeth Glaser Pediatric AIDS Foundation

    lead OTHER

Principal Investigators

  • Boris K Tchounga, MD, PhD · Elizabeth Glaser Pediatric AIDS Foundation

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2022-06-30
Completion
2022-10-30

Countries

  • Cameroon

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05341791 on ClinicalTrials.gov