title: Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.
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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK ; London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
authors.forename: Muhammed Olanrewaju
authors.initials: MO
authors.lastname: Afolabi
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.affiliation: Centre for Clinical Vaccinology and Tropical Medicine, the Jenner Institute, Oxford University Churchill Hospital, Oxford, OX3 7LJ, UK.
authors.forename: Egeruan Babatunde
authors.initials: EB
authors.lastname: Imoukhuede
authors.affiliation: Institute of Tropical Medicine, Antwerp & KU Leuven, Belgium.
authors.forename: Raffaella M
authors.initials: RM
authors.lastname: Ravinetto
authors.affiliation: London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
authors.forename: Heidi Jane
authors.initials: HJ
authors.lastname: Larson
authors.affiliation: University of Southampton, Southampton, Mailpoint 805, C floor, South Academic Block, Southampton General Hospital, Southampton, SO16 6YD, UK.
authors.forename: Nuala
authors.initials: N
authors.lastname: McGrath
authors.affiliation: London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
keywords: Development; Informed consent; Technology; The Gambia; Video; Vulnerable population