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Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods
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2 2012
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Source: AIDS Behav. 2011; 16(2):412-421
[PDF-1003.03 KB]
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Alternative Title:AIDS Behav
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Description:Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3). Understanding of research concepts and study procedures was assessed immediately postintervention and at 1-week follow-up. At postintervention, participants in groups 2 and 3 understood more about research concepts and study procedures compared with group 1. Group 3 participants also understood more about study procedures compared with group 2. At follow-up, participants in groups 2 and 3 continued to understand more about research concepts and study procedures. Context-specific approaches improved understanding of consent information in this study.
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Pubmed ID:21656146
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Pubmed Central ID:PMC3923514
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Volume:16
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Issue:2
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