학술논문
Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods
Document Type
Original Paper
Author
Corneli, Amy L.; Sorenson, James R.; Bentley, Margaret E.; Henderson, Gail E.; Michael Bowling, J.; Nkhoma, Jacqueline; Moses, Agnes; Zulu, Cynthia; Chilima, James; Ahmed, Yusuf; Heilig, Charles M.; Jamieson, Denise J.; van der Horst, Charles; Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group
Source
AIDS and Behavior. February 2012 16(2):412-421
Subject
Language
English
ISSN
1090-7165
1573-3254
1573-3254
Abstract
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.