Journal article
Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods
AIDS and behavior, Vol.16(2), pp.412-421
02/01/2012
DOI: 10.1007/s10461-011-9977-z
PMCID: PMC3923514
PMID: 21656146
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.
Details
- Title: Subtitle
- Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods
- Creators
- Amy L. Corneli - University of North Carolina at Chapel HillJames R. Sorenson - University of North Carolina at Chapel HillMargaret E. Bentley - University of North Carolina at Chapel HillGail E. Henderson - University of North Carolina at Chapel HillJ. Michael Bowling - University of North Carolina at Chapel HillJacqueline Nkhoma - UNC Project, Lilongwe, MalawiAgnes Moses - UNC Project, Lilongwe, MalawiCynthia Zulu - UNC Project, Lilongwe, MalawiJames ChilimaYusuf Ahmed - Centers for Disease Control and PreventionCharles M. Heilig - Centers for Disease Control and PreventionDenise J. Jamieson - Centers for Disease Control and PreventionCharles van der Horst - University of North Carolina at Chapel HillBreastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group
- Resource Type
- Journal article
- Publication Details
- AIDS and behavior, Vol.16(2), pp.412-421
- Publisher
- Springer Nature
- DOI
- 10.1007/s10461-011-9977-z
- PMID
- 21656146
- PMCID
- PMC3923514
- ISSN
- 1090-7165
- eISSN
- 1573-3254
- Number of pages
- 10
- Grant note
- U48 DP000059; U48-DP000059-01 / NCCDPHP CDC HHS U48DP000059 / NATIONAL CENTER FOR CHRONIC DISEASE PREV AND HEALTH PROMO; United States Department of Health & Human Services; Centers for Disease Control & Prevention - USA 2-D43 TW01039-06 / FIC NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Fogarty International Center (FIC) P30AI050410 / NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) P30 AI050410; P30-AI50410 / NIAID NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Allergy & Infectious Diseases (NIAID) D43TW001039 / FOGARTY INTERNATIONAL CENTER; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Fogarty International Center (FIC) R24 HD050924 / NICHD NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) R24HD050924 / EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
- Language
- English
- Date published
- 02/01/2012
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446533502771
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