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

A randomized, preliminary proof of concept study evaluating two types of supplemental information that would serve as an adjunct to the traditional informed consent in an HIV vaccine clinical trial. Participants were administered a standard HIV vaccine trial consent form and were then randomized into three conditions: no supplemental information provided, supplemental information with 1-sided messages provided, and supplemental information with 2-sided messages provided. Interviewers administered Part 1 of a two-part questionnaire before the informed consent was reviewed with participants. Part 2 of the questionnaire was administered either directly after the informed consent in the control condition, or after participants read through supplemental materials in the other two conditions. A debriefing interview was conducted with selected participants to review their understanding of the study procedures and reactions to the supplemental materials and/or questionnaires.