A randomized trial comparing concise and standard consent forms in the START trial.

ABSTRACT:

Background

Improving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed.

Methods

We conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site co

SUBMITTER: Grady C 

PROVIDER: S-EPMC5406127 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature