title: A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.
abstract: OBJECTIVE
  To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia.
  
  
  METHODS
  Adults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups.
  
  
  RESULTS
  On day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand.
  
  
  CONCLUSIONS
  A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, PO Box 273, Banjul, the Gambia .
authors.forename: Muhammed Olanrewaju
authors.initials: MO
authors.lastname: Afolabi
authors.affiliation: University of Southampton, Southampton, England .
authors.forename: Nuala
authors.initials: N
authors.lastname: McGrath
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, PO Box 273, Banjul, the Gambia .
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, PO Box 273, Banjul, the Gambia .
authors.forename: Beate
authors.initials: B
authors.lastname: Kampmann
authors.affiliation: The Jenner Institute, University of Oxford, Oxford, England .
authors.forename: Egeruan B
authors.initials: EB
authors.lastname: Imoukhuede
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium .
authors.forename: Raffaella M
authors.initials: RM
authors.lastname: Ravinetto
authors.affiliation: London School of Hygiene & Tropical Medicine, London, England .
authors.forename: Neal
authors.initials: N
authors.lastname: Alexander
authors.affiliation: London School of Hygiene & Tropical Medicine, London, England .
authors.forename: Heidi J
authors.initials: HJ
authors.lastname: Larson
authors.affiliation: London School of Hygiene & Tropical Medicine, London, England .
authors.forename: Daniel
authors.initials: D
authors.lastname: Chandramohan
authors.affiliation: Medical Research Council Unit, Atlantic Road, Fajara, PO Box 273, Banjul, the Gambia .
authors.forename: Kalifa
authors.initials: K
authors.lastname: Bojang
mesh_terms: D000328:Adult; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage; D032882:Comprehension; D005260:Female; D017144:Focus Groups; D005714:Gambia; D057220:Health Literacy / Q000706:statistics & numerical data*; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D008288:Malaria / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D019212:Multimedia / Q000706:statistics & numerical data*; D011319:Primaquine / Q000008:administration & dosage; D035842:Research Subjects / Q000523:psychology* / Q000706:statistics & numerical data; D017678:Sex Distribution; D016019:Survival Analysis; D055815:Young Adult
chemical_list: D000962:Antimalarials; D011319:Primaquine