title: Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi.
abstract: BACKGROUND
  The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants' understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy.
  
  
  METHODS
  The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study.
  
  
  RESULTS
  The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer's exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001).
  
  
  CONCLUSIONS
  Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.
authors.affiliation: HJF-DAIDS, NIAID, NIH, 6700A Rockledge Drive Room 42A193, Second Floor, Bethesda, MD 20817, USA. pndexas@yahoo.com
authors.forename: Paul M
authors.initials: PM
authors.lastname: Ndebele
authors.forename: Douglas
authors.initials: D
authors.lastname: Wassenaar
authors.forename: Esther
authors.initials: E
authors.lastname: Munalula
authors.forename: Francis
authors.initials: F
authors.lastname: Masiye
mesh_terms: D000328:Adult; D000383:Agriculture; D000890:Anti-Infective Agents / Q000008:administration & dosage; D032882:Comprehension / Q000941:ethics; D003210:Concept Formation; D003466:Cultural Characteristics; D004311:Double-Blind Method; D004522:Educational Status; D032984:Ethics, Research; D005260:Female; D006801:Humans; D058980:Information Literacy; D007258:Informed Consent / Q000941:ethics / Q000523:psychology; D007802:Language; D008295:Malawi; D016555:Matched-Pair Analysis; D008875:Middle Aged; D033262:Narration; D010919:Placebos / Q000008:administration & dosage; D011897:Random Allocation; D012107:Research Design; D012108:Research Personnel; D035842:Research Subjects / Q000523:psychology; D013663:Teaching / Q000379:methods*; D035862:Vulnerable Populations / Q000523:psychology; D014930:Women / Q000193:education / Q000523:psychology
chemical_list: D000890:Anti-Infective Agents; D010919:Placebos