Programme : What is the role of informed consent in medical research? : Abstract of presentation
Multi-media educational tool (speaking book) increases knowledge of clinical trials among HIV-positive patients in Kampala, Uganda
Gavin Robertson 1; Soeren Rasmussen 2; Richard Hubbard 2; Kevin Newell 3; Margaret Denty 1; Yukari Manabe 1
1Makerere University, Infectious Diseases Institute, Faculty of Medicine, Kampala, Uganda; 2Pfizer, Inc, Medical Division, New York, United States; 3Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland, United States
Background: Sufficient knowledge and the process of obtaining informed consent present specific challenges with low literacy patients. Our objective was to evaluate the improvement in knowledge in low-literacy patients about the process of clinical trials and the rights and responsibilities of clinical trial participants using an educational tool, the ‘Clinical Trials Speaking Book’.
Methods: This was a randomized controlled trial conducted at the Infectious Diseases Institute in Kampala, Uganda. Participants were randomized to 1) a standard informed consent discussion (Control arm), or 2) an informed consent discussion involving instruction on using the Speaking Book with a take home copy (Speaking Book arm). The discussion content covered in both arms was the same. After the discussion, participants completed a multiple choice test on clinical trials and the rights and responsibilities of participants. A week later they completed the same test to assess knowledge retention.
Results: 91 participants completed both the initial and follow-up tests in the Control arm and 100 in the Speaking Book 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 and 19% had participated. Regarding Clinical Trial knowledge scores, the change in proportion of correct responses from test 1 to test 2 was 2.7 (95%CI 0.3-5.0) for the Control Group and 11.5 (95%CI 9.3-13.7) for the Speaking Book Group (t-score= -5.3, p-value<0.0001).
Conclusion: Participants who had instruction in the use of the Speaking Book and used it for one week had a statistically significantly larger increase in knowledge assessment score than those who had no access to this tool. With patients of low-literacy, innovative techniques can assist in increasing the knowledge that potential participants acquire to make a more informed choice about participation in Clinical Trials.
Email: grobertson@idi.co.ug
This conference is arranged by Cesagen at the universities of Lancaster and Cardiff and the Centre for Research Ethics & Bioethics at Uppsala University.