Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.

Area of Science:

• Clinical Research Ethics
• Health Communication
• Global Health

Background:

• International guidelines emphasize tailored informed consent for low literacy populations.
• Traditional written consent may not ensure adequate comprehension in research settings.
• Malaria treatment trials require robust informed consent processes.

Purpose of the Study:

• To develop and evaluate a multimedia informed consent tool for low literacy individuals.
• To assess the tool's acceptability, ease of use, and effectiveness in a Gambian malaria trial context.

Main Methods:

• Developed a multimedia tool with video, animations, and audio in local languages.
• Assessed acceptability and usability via quantitative and qualitative methods.
• Measured comprehension using a validated digital audio questionnaire across two visits.

Main Results:

• 70% of participants found the multimedia tool clear and easy to understand.
• High comprehension scores for adverse events, voluntary participation, and study procedures.
• Statistically significant improvements in recall and understanding between study visits (p<0.00001).

Conclusions:

• The developed multimedia tool is acceptable and effective for low literacy populations in The Gambia.
• The tool enhances and sustains comprehension of complex study information.
• Further research is recommended to compare this tool with traditional methods in sub-Saharan Africa.