Evidence map›Paper›PMID 21656146›Full record

ArticleAIDS and behavior2012

Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.

Amy L Corneli, James R Sorenson, Margaret E Bentley, Gail E Henderson, J Michael Bowling, Jacqueline Nkhoma, Agnes Moses, Cynthia Zulu, James Chilima, Yusuf Ahmed and 4 more

Abstract readComparative StudyMulticenter Study
In one paragraph

Article in AIDS and behavior, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Amy L CorneliDepartment of Health Behavior and Health Education, The University of North Carolina at Chapel Hill, USA. acorneli@fhi.org
James R Sorenson
Margaret E Bentley
Gail E Henderson
J Michael Bowling
Jacqueline Nkhoma
Agnes Moses
Cynthia Zulu
James Chilima
Yusuf Ahmed
Charles M Heilig
Denise J Jamieson
Charles van der Horst
Breastfeeding, Antiretroviral, and Nutrition Informed Consent Study Group

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
UNC Center for Health Promotion and Disease PreventionU48DP000059 · DP · UNIV OF NORTH CAROLINA CHAPEL HILL · PI AMMERMAN, ALICE S · 2004 to 2009
$14.4M
Carolina Population CenterR24HD050924 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MORGAN, SAMUEL PHILIP · 2005 to 2014
$10.0M
AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAMD43TW001039 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ADIMORA, ADAORA A · 1998 to 2013
$9.9M
FIC NIH HHS 2-D43 TW01039-06NCCDPHP CDC HHS U48 DP000059NCCDPHP CDC HHS U48-DP000059-01NIAID NIH HHS P30 AI050410NIAID NIH HHS P30-AI50410NICHD NIH HHS R24 HD050924
6 · The paper itself

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.

Indexed as

ComprehensionInformed ConsentAnti-HIV AgentsBreast FeedingFemaleFollow-Up StudiesHIV SeropositivityHumansInfant, NewbornInfectious Disease Transmission, VerticalMalawiPatient Education as TopicPatient SatisfactionPregnancyPregnancy Complications, InfectiousSurveys and QuestionnairesAnti-HIV Agents

Identifiers

PMID21656146
PMCPMC3923514

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.