Preventative Misconception Intervention

Summary

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.

Conditions

• HIV
• HIV Infections

Interventions

BEHAVIORAL

1-sided messages

Supplemental information with 1-sided messages (emphasizes information content related to vaccine trial randomization and unproven efficacy of vaccine).

BEHAVIORAL

2-sided messages

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).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Gregory Zimet, Ph.D. · Adolescent Trials Network

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2010-09-30

Completion

2010-09-30

Countries

• United States

Study Locations