Trial reportTrials2013
Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00878007 (Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.
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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.
Impact of Malaria Prevention on Health and Education in Kenyan Schoolchildren
Who cites it
28 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Models for malaria control optimization-a systematic review.Malaria journal · 2024Pooled it
- Targeted Testing and Treatment To Reduce Human Malaria Transmission in High-Risk Populations: A Systematic Review.The American journal of tropical medicine and hygiene · 2024Pooled it
- Pooled it
- Trial
- Trial
- Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.The Lancet. Global health · 2018Trial
- Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial.PLoS medicine · 2014Trial
- Perceptions of Stress, Well-Being, and Intervention Preferences Among Parents Affected by Major Stressors.Healthcare (Basel, Switzerland) · 2025Article
- Reimagining Assent: When Things Get Lost in Translation in International Pediatric Research.Asian bioethics review · 2025Article
- Perceptions and beliefs of community gatekeepers about genomic risk information in African cleft research.BMC public health · 2024Article
- Community engagement in research addressing infectious diseases of poverty in sub-Saharan Africa: A qualitative systematic review.PLOS global public health · 2024Article
- Article
- Clinical research on COVID-19: perceptions and barriers to participation in The Gambia.BMJ global health · 2022Article
- Correlates of attendance at community engagement meetings held in advance of bio-behavioral research studies: A longitudinal, sociocentric social network study in rural Uganda.PLoS medicine · 2021Article
- Community-structures that facilitate engagement in health research: Ifakara Health Research Institute-Bagamoyo case study.AAS open research · 2021Article
- Assent and consent in adolescent research: teachers' perspectives from a developing country.Heliyon · 2020Article
- Lessons learned from engaging communities for Ebola vaccine trials in Sierra Leone: reciprocity, relatability, relationships and respect (the four R's).BMC public health · 2019Article
- Assent and consent in pediatric and adolescent research: school children's perspectives.Adolescent health, medicine and therapeutics · 2019Article
- Tackling malaria transmission in sub-Saharan Africa.The Lancet. Global health · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundThere are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya.
methodsData collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors' experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial.
resultsEarly meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period.
conclusionsA range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa.
trial registrationNational Institute of Health NCT00878007.
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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.