Simplified Consent for HIV Vaccine Trials

Completed

Conditions studied: Adolescent Behavior

In brief

The main goal of this project is to develop and evaluate a simplified version of an HIV vaccine trial consent form designed for high-risk adolescents. The process will include: (1) reducing reading grade level by simplifying sentence structure and decreasing the use of infrequently used words; (2) re-organizing and categorizing the material for improved flow; and (3) developing a set of pictures to emphasize key concepts in the material. These materials will be tested among small focus groups of high-risk adolescents. A pre-post test design will be used to compare the simplified, adolescent-tailored consent form to one currently used in the National Institute of Allergy and Infection Diseases (NIAID) Vaccine Trial Information Booklet.

Key facts

Study ID

NCT00105339

Run by

University of North Carolina, Chapel Hill

People needed

255

Starts

2003-12-01

Expected to finish

2004-02-01

Last updated by the study team

2017-03-01

Who can join

Age: 15 and older, up to 19. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ages 15 to 19 years (self identified)
• At risk for HIV/AIDS as determined by responses to an anonymous screen for sexual risk
• Giving assent or consent, depending on age
• English-speaking

You may not qualify if…

• Non-English speaking
• Not shown to be at risk through use of screener
• Unwilling/unable to provide informed consent/assent

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Children's Diagnostic and Treatment Center — Fort Lauderdale, Florida, United States
• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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