Informed Consent Substudy: A Substudy of Strategic Timing of AntiRetroviral Treatment (START)

Date Commenced:
04/2009
Project Status
Ongoing
Expected Date of Completion:
Ongoing
Project Supporters

DAIDS, NHMRC and several other funding bodies

Currently recruiting
Yes
image - Start Logo 284x284 4

About the Project

Project Collaborators: External

Total of 33 sites in the Sydney region.

Australia (12 sites); Thailand (9 sites); Argentina (10 sites); Chile (1 site); Mexico (1 site)

Rationale

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.

Aims

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.
Progress/Update

As of 13 September 2011 118 sites openglobally, 17 sites open in the Sydney region (randomisation is at a site level).

Project Members
image - Megan Evans Clewett
Clinical Project Coordinator
Ph +61 (0)2 9385 0900
image - 1343191211 Cate Carey Replace
Senior Clinical Project Coord
Ph +61 (0)2 9385 0900
image - Simone New
Clinical Project Coordinator
Ph +61 (0)2 9385 0900
image - 1338436367 Sean Emery.jpg
Professor and Program Head
Ph +61 (0)2 9385 0900
image - 1342575784 Pamela Findlay Tvrp.jpg
Administrative Assistant
Ph +61 (0)2 9385 0901
Project Research Area

Project Contacts

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