This sub-study is evaluating understanding of study information and satisfaction with the consent process among research participants of the START protocol, after receiving information from one of two different types of consent form: a standard or a concise consent.
To determine whether comprehension and understanding in regard to START study participation is equivalent when using a short consent vs. standard consent.
• The proportion of participants giving correct answers to questions about randomization.
• Mean scores on the comprehension section of the instrument;
• composite score of the satisfaction questions;
• A composite score of the voluntariness questions;
• Evaluation of IRB/IEC required changes to the consent documents.
Design & Method
This is a randomized study to evaluate and compare the following two groups in START:
A standard group in which participants receive the standard detailed consent form.
A concise group in which participants receive a shorter, less-complex, consent form written at a lower reading level.
As of 13 September 2011 118 sites openglobally, 17 sites open in the Sydney region (randomisation is at a site level).