1. Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial.
- Author
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Blake, Diane R., Lemay, Celeste A., Maranda, Louise S., Fortenberry, J. Dennis, Kearney, Margaret H., and Mazor, Kathleen M.
- Subjects
HIV prevention ,CHI-squared test ,INFORMED consent (Medical law) ,MEDICAL research ,PSYCHOLOGICAL tests ,QUESTIONNAIRES ,REGRESSION analysis ,RESEARCH funding ,T-test (Statistics) ,VIRAL vaccines ,WORLD Wide Web ,RANDOMIZED controlled trials ,HEALTH literacy ,DATA analysis software ,DESCRIPTIVE statistics - Abstract
HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15–17 years, from five community organizations were randomized to self-administered web-based assent (n= 60) or investigator-administered paper assent with (n= 29) or without (n= 31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118= –0.08,p= 0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58= 1.96,p= 0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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