Evaluation of an intervention among adolescents to reduce preventive misconception in HIV vaccine clinical trials.

ABSTRACT

PURPOSE: Placebo and randomization are important concepts that must be understood before youth can safely participate in HIV vaccine studies or other biomedical trials for HIV prevention. These concepts are central to the phenomenon of preventive misconception that may be associated with an increase in risk behavior among study participants related to mistaken beliefs. Persuasive messaging, traditionally used in the field of marketing, could enhance educational efforts associated with randomized clinical trials. METHODS: Two educational brochures were designed to increase knowledge about HIV vaccine clinical trials via one- and two-sided persuasive messaging. Through the Adolescent Medicine Trials Network, 120 youth were enrolled, administered a mock HIV vaccine trial consent, and then randomized to receive either no supplemental information or one of the two brochures. RESULTS: The two-sided brochure group in which common clinical trial misconceptions were acknowledged and then refuted had significantly higher scores on knowledge of randomization and interpretation of side effects than the consent-only control group, and the willingness to participate in an HIV vaccine trial was not decreased with the use of this brochure. CONCLUSION: Two-sided persuasive messaging improves understanding of the concepts of randomization and placebo among youth who would consider participating in an HIV vaccine trial. Further evaluation of this approach should be considered for at-risk youth participating in an actual trial of a biomedical intervention for HIV prevention.