Trial reportBMC medical ethics2012
Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi.
Trial report in BMC medical ethics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Do studies of interventions to improve laypeople's critical thinking about health choices assess potential harms? A systematic review.BMJ open · 2026Pooled it
- Educational interventions to improve people's understanding of key concepts in assessing the effects of health interventions: a systematic review.Systematic reviews · 2018Pooled it
- Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial.BMJ global health · 2025Trial
- Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.BMC medical ethics · 2016Trial
- Community perceptions, trust, and experiences of malaria clinical research and participation in rural Cambodia.Tropical medicine and health · 2026Article
- Researchers experience and views on participants' comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study.BMC medical ethics · 2024Article
- Standard of prevention for infectious diseases' prevention clinical trials during pandemics: learning lessons for global policies from biomedical HIV prevention clinical trials and a case study of COVID-19.Frontiers in public health · 2024Article
- Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.BMC medical ethics · 2023Article
- Understanding of Critical Elements of Informed Consent in Genomic Research: A Case of a Paediatric HIV-TB Research Project in Uganda.Journal of empirical research on human research ethics : JERHRE · 2022Article
- Article
- Considerations for an integrated population health databank in Africa: lessons from global best practices.Wellcome open research · 2021Article
- Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.Bioethics · 2020Article
- Ethical issues associated with HIV molecular epidemiology: a qualitative exploratory study using inductive analytic approaches.BMC medical ethics · 2019Article
- Traditional, complementary, and alternative medical cures for HIV: rationale and implications for HIV cure research.Global public health · 2019Review
- Lessons learned from using an audience response system in a community setting for research data collection.Public health nursing (Boston, Mass.) · 2018Article
- The Significance of Benefit Perceptions for the Ethics of HIV Research Involving Adolescents in Kenya.Journal of empirical research on human research ethics : JERHRE · 2017Article
- Rapid Ethical Assessment on Informed Consent Content and Procedure in Hintalo-Wajirat, Northern Ethiopia: A Qualitative Study.PloS one · 2016Article
- Testing the waters: Ethical considerations for including PrEP in a phase IIb HIV vaccine efficacy trial.Clinical trials (London, England) · 2015Article
- I'm positive, but i'm negative: Competing Voices in Informed Consent and Implications for HIV vaccine trials.Journal of empirical research on human research ethics : JERHRE · 2015Article
- Consent and community engagement in diverse research contexts.Journal of empirical research on human research ethics : JERHRE · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundThe intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants' understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy.
methodsThe intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study.
resultsThe findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer's exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001).
conclusionsPotential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.