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Evaluation of an Intervention Among Adolescents to Reduce Preventive Misconception in HIV Vaccine Clinical Trials

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. 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. 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. 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.

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Messages and Medical Behaviors: DTCA's Influence on Healthcare Consumer Thinking and Doing, and How We Can Help

Pharmaceutical direct-to-consumer advertising (DTCA) has grown exponentially and is suggested to increase perceived medication needs and patient drug requests. However, its impact on healthcare consumer safety is not well-understood. This effort sought to examine DTCA healthcare consumer effects and their public health and practical implications. During spring 2008, 2767 individuals were asked, through public intercept interviews, about pharmaceutical DTCA: recalled products, exposure frequency, exposure medium, and impact on a range of health-related behaviors and beliefs. Consumers report inundation with DTCA, with 8 of 10 respondents indicating exposure to messaging within the past 30 days. Television was the medium with the most noted impressions; direct mail, the least (although still >35%). Most impressions reported were for Viagra and Claritin. One of four participants reported cognitive or behavioral changes as a result of viewing DTCA: advertisements prompted people to believe they had an illness/condition, to seek more information, to schedule provider visits, and to ask providers about symptoms or medications during regular visits. Moreover, almost 1 in 5 reported an increased willingness to share their prescription medication with others if they saw it in DTCA, indicating that DTCA exposure may increase this risky behavior. DTCA are nearly ubiquitous yet consumers remained attuned to the message content. The effects of DTCA are complex and range from beneficial (e.g., information-seeking) to detrimental (e.g. medication-sharing). Interestingly, participants do not readily differentiate prescription versus over-the-counter DTCA. Increased attention to understanding DTCA appears worthwhile, perhaps targeting provider awareness of message effect, further regulation and modification of DTCA messaging, and enhancing DTCA media literacy as a component of health literacy. Human factors professionals have the right toolset to play an active role in these efforts.

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