Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods

Corneli, Amy L.; Sorenson, James R.; Bentley, Margaret E.; Henderson, Gail E.; Bowling, J. Michael; Nkhoma, Jacqueline; Moses, Agnes; Zulu, Cynthia; Chilima, James; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.; van der Horst, Charles

doi:10.1007/s10461-011-9977-z

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Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods

Published Date:

Feb 2012

Publisher's site:

http://dx.doi.org/10.1007/s10461-011-9977-z New Site Icon

Source:

AIDS Behav. 2011; 16(2):412-421.

[PDF - 1003.03 KB]

Details:

Personal Authors:

Corneli, Amy L. ; Sorenson, James R. ; Bentley, Margaret E. ; Henderson, Gail E. ; Bowling, J. Michael ; ... More ▼

Corporate Authors:

Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group

Keywords:

[+]

Pubmed ID:

21656146

Pubmed Central ID:

PMC3923514

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.

Document Type:

Journal Article

Collection(s):

CDC Public Access

Funding:

2-D43 TW01039-06/TW/FIC NIH HHS/United States
P30 AI050410/AI/NIAID NIH HHS/United States
P30-AI50410/AI/NIAID NIH HHS/United States
R24 HD050924/HD/NICHD NIH HHS/United States
U48-DP000059-01/DP/NCCDPHP CDC HHS/United States

Supporting Files:

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nihms527999f1.jpg	image/jpeg

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