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Background Assessments of understanding (AoUs) in clinical trials are often composed of true/false multiple choice questions, however, these tools can be difficult for volunteers with limited education or without prior testing experience. Methods 35 adults were recruited at two research centers in Southern Africa. A within-subjects, repeated measures design was used, whereby each volunteer served as his/ her own control. An AoU tool with closed- and openended questions was administered within a hypothetical AIDS vaccine trial setting. Performance on closed- and open-ended questions was compared using correlations and repeated-measure t-tests, limited to 4 complex concepts: false sense of security, risk of false positive test, need for contraception, and potentially enhanced susceptibility.

A mixed-methods assessment of understanding (AoU) tool for AIDS vaccine trials in sub-Saharan Africa: results from a pilot study