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

Details

• Alternative Title:
  AIDS Behav
• Personal Author:
  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
  More +
• Corporate Authors:
  Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group
• 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.
• Subjects:
  • Anti-HIV Agents
  • Breast Feeding
  • Comprehension
  • Female
  • Follow-Up Studies
  • HIV Seropositivity
  • Humans
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical
  • Informed Consent
  More +
• Keywords:
  • Informed consent
  • Evaluation
  • Comprehension
  • Africa
• Source:
  AIDS Behav. 2011; 16(2):412-421
• Pubmed ID:
  21656146
• Pubmed Central ID:
  PMC3923514
• Document Type:
  Journal Article
• Funding:
  U48-DP000059-01/DP/NCCDPHP CDC HHSUnited States/ ; P30-AI50410/AI/NIAID NIH HHSUnited States/ ; R24 HD050924/HD/NICHD NIH HHSUnited States/ ; U48 DP000059/DP/NCCDPHP CDC HHSUnited States/ ; 2-D43 TW01039-06/TW/FIC NIH HHSUnited States/ ; P30 AI050410/AI/NIAID NIH HHSUnited States/
• Place as Subject:
  Malawi
• Volume:
  16
• Issue:
  2
• Download URL:
  https://stacks.cdc.gov/view/cdc/33661/cdc_33661_DS1.pdf
• File Type:
  [PDF - 1003.03 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:f2006951fce5c187a3978b53f5a92aa742f6f99988f9aca5246188794fe1a27b