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Informed Consent Substudy

Participant Informed Consent forms for randomised clinical trial are often long and technical. Data have shown that despite comprehensive written information participants in clinical trials have limited understanding of the study information they receive. The purpose of this substudy is to compare understanding of study information and satisfaction with the consent process among START research participants, after receiving information from one of two different types of consent forms:

1) Standard Informed Consent form:
Participants receive the standard detailed informed consent form and discuss the study with one or more members of the research team.

or

2) Concise Informed Consent form:
Participants receive a shorter, less-complex consent form, written at a lower reading level and discuss the study with one or more members of the research team.

Both the standard and the concise form contain all of the required elements that must be part of an informed consent according to federal regulations, and include information needed to make an informed decision about participating in START. Participating sites were randomised to use either the standard or the concise consent form. Randomization was stratified by language and country at the time of site registration with the sponsor
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