title: Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.
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.
authors.affiliation: Department of Health Behavior and Health Education, The University of North Carolina at Chapel Hill, USA. acorneli@fhi.org
authors.forename: Amy L
authors.initials: AL
authors.lastname: Corneli
authors.forename: James R
authors.initials: JR
authors.lastname: Sorenson
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Bentley
authors.forename: Gail E
authors.initials: GE
authors.lastname: Henderson
authors.forename: J Michael
authors.initials: JM
authors.lastname: Bowling
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Nkhoma
authors.forename: Agnes
authors.initials: A
authors.lastname: Moses
authors.forename: Cynthia
authors.initials: C
authors.lastname: Zulu
authors.forename: James
authors.initials: J
authors.lastname: Chilima
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.forename: Charles M
authors.initials: CM
authors.lastname: Heilig
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Jamieson
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage*; D001942:Breast Feeding / Q000379:methods*; D032882:Comprehension; D005260:Female; D005500:Follow-Up Studies; D006679:HIV Seropositivity / Q000453:epidemiology / Q000635:transmission*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007258:Informed Consent / Q000941:ethics; D008295:Malawi / Q000453:epidemiology; D010353:Patient Education as Topic / Q000379:methods*; D017060:Patient Satisfaction; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000139:chemically induced*; D011795:Surveys and Questionnaires; D013664:Teaching Materials; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents