Paper Title
Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial
Keywords
- clinical trials
- hiv infection and aids
- aids
- research ethics
- informed consent
- hiv vaccine trials
- adolescents
- hiv infection
- assent process
- web-based learning
- computer-assisted instruction
- adolescent comprehension
- parental permission
- bioethics
- health education
- interactive learning
- digital health tools
- informed decision-making
- medical research ethics
- online assent platforms
- youth participation
- adolescence
Article Type
Original Article
Journal
Research Impact Tools
Publication Info
Volume: 27 | Issue: 8 | Pages: 1005-1013
Published On
March, 2015
Downloads
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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.
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