alexa Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing
ISSN: 2155-9627

Journal of Clinical Research & Bioethics
Open Access

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Research Article

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

Muhammed Olanrewaju Afolabi1,2*, Kalifa Bojang1, Umberto D’Alessandroa1, Egeruan Babatunde Imoukhuede3, Raffaella M Ravinetto4, Heidi Jane Larson2 and Nuala McGrath5

1Medical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK

2London School of Hygiene and Tropical Medicine, Keppel Street, WC1E7HT, UK

3Centre for Clinical Vaccinology and Tropical Medicine, the Jenner Institute, Oxford University Churchill Hospital, Oxford, OX3 7LJ, UK

4Institute of Tropical Medicine, Antwerp & KU Leuven, Belgium

5University of Southampton, Southampton, Mailpoint 805, C floor, South Academic Block, Southampton General Hospital, Southampton, SO166YD, UK

*Corresponding Author:
Muhammed Afolabi
Medical Research Council Unit
Fajara, P.O Box 273, Banjul, The Gambia, USA
Tel: +220-7059861
E-mail: [email protected]

Received date: February 12, 2014; Accepted date: March 21, 2014; Published date: April 05, 2014

Citation: Afolabi MO, Bojang K, D’Alessandroa U, Imoukhuede EB, Ravinetto RM, et al. (2014) Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing. J Clin Res Bioeth 5:178. doi: 10.4172/2155-9627.1000178

Copyright: © 2014 Afolabi MO, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Background: International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information.

Objectives: This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia.

Methods: We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants’ comprehension of the study information was measured by using a validated digitised audio questionnaire.

Results: The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants’ ‘recall’ and ‘understanding’ between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively.

Conclusions: Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

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