Preventative Misconception Intervention

This study will carry out a preliminary "proof of concept" to evaluate two types of
supplemental information that would serve as an adjunct to the traditional informed consent
in a Human Immunodeficiency Virus (HIV) vaccine clinical trial. These will be compared to
the condition where the traditional informed consent form is used alone.

Using four intervention sites, participants will be administered a standard HIV vaccine
trial consent form. They will then be randomized into three conditions: 1) No supplemental
information; 2) Supplemental information with 1-sided messages (emphasizes information
content related to vaccine trial randomization and unproven efficacy of vaccine); and 3)
Supplemental information with 2-sided messages (acknowledges the beliefs that are at odds
with the information content and seeks to neutralize those beliefs through
counter-argument). An interviewer-administered questionnaire (IAQ) Part 1 will be
administered before the traditional HIV vaccine trial informed consent is reviewed with the
participant. An IAQ Part 2 will be administered directly after the HIV vaccine trial
informed consent in the control condition or after reading through the supplemental
material. Debriefing interviews will be conducted with selected participants to review their
understanding of the study procedures and their reactions to the supplemental materials
and/or questionnaires.

The proposed research is a "proof of concept" study and is therefore not designed to test
hypotheses. Consequently, formal hypothesis and related power calculations to detect certain
effect sizes are not required. Instead, the goal will be to enroll an appropriate number of
subjects for purpose of determining the feasibility of developing a larger study of
supplemental information to be used as an adjunct to the informed consent statement in HIV
vaccine clinical trials and providing related descriptive statistics.