title: Multi-Media Educational Tool Increases Knowledge of Clinical Trials in Uganda.
abstract: BACKGROUND
  Informed consent is premised on the participants' understanding the scope of the research and the associated risks and benefits. The objective was to evaluate the improvement in knowledge in a population unfamiliar with clinical trial concepts about "what it means to be part of a clinical trial" using an innovative educational tool called the 'Speaking Book'.
  
  
  METHODS
  This was a randomized controlled trial conducted at a research site in Uganda. 201 participants were randomized to: 1) clinical trials information session control arm, or 2) clinical trials information session followed by instruction in the use of the Speaking Book with a take-home copy (intervention arm). After the session, participants of both groups completed a 22-item multiple-choice test on the rights and responsibilities of participants. Participants returned after one week to complete the same test to assess knowledge retention. The mean pre- and post-test score difference was assessed according to trial arm using an unpaired t-test of proportions.
  
  
  RESULTS
  Ninety-one (90%) participants completed both the initial and follow-up tests in the control arm and 100 (100%) in the intervention arm. The average age of participants was 38 years, 53% were female and 67% were employed; 20% had previously been invited to participate in a clinical trial; of these, 19% had participated. The mean difference in proportion of correct responses from test 1 to test 2 was 2.7% (95%CI 0.3%-5.0%) for the control arm and 11.6% (95%CI 9.3%-13.7%) for the intervention arm (t-score= -5.3, p-value<0.0001).
  
  
  CONCLUSIONS
  Participants who had instruction in the use of the Speaking Book had a larger increase in knowledge than those who had no access to this tool. To better engage patients unfamiliar with clinical trial concepts, innovative educational techniques can assist to increase knowledge to make an informed decision about participation in a clinical trial.
authors.affiliation: Infectious Diseases Institute, Makerere College of Health Sciences, Kampala, Uganda.
authors.forename: Barbara
authors.initials: B
authors.lastname: Castelnuovo
authors.affiliation: Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc. (formerly SAIC-Frederick Inc.), Frederick National Laboratory for Cancer Research, Frederick, MD 21702.
authors.forename: Kevin
authors.initials: K
authors.lastname: Newell
authors.affiliation: Infectious Diseases Institute, Makerere College of Health Sciences, Kampala, Uganda ; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Yukari C
authors.initials: YC
authors.lastname: Manabe
authors.affiliation: Infectious Diseases Institute, Makerere College of Health Sciences, Kampala, Uganda.
authors.forename: Gavin
authors.initials: G
authors.lastname: Robertson
keywords: clinical trials; informed consent; speaking book