Development and evaluation of a web-based assent for adolescents considering an HIV vaccine trial

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.

Keywords:

• clinical trials
• HIV infection and AIDS
• research ethics
• informed consent
• adolescence
• computer-assisted instruction

Acknowledgments

The authors thank Debra A. Murphy, Ph.D., for her consultation and for allowing us to use her simplified consent in this study. We thank Charles W. Lidz, Ph.D. for his consultation and expertise on consent and ethics. We are grateful to all of the youth who participated in this study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

All phases of this study were supported by NIH Grant [grant number 1R21HD057786-01] from the National Institute of Child Health and Human Development (NICHD). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NICHD.