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Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya

BACKGROUND: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more...

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Autores principales: Angwenyi, Vibian, Kamuya, Dorcas, Mwachiro, Dorothy, Kalama, Betty, Marsh, Vicki, Njuguna, Patricia, Molyneux, Sassy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3974049/
https://www.ncbi.nlm.nih.gov/pubmed/24565019
http://dx.doi.org/10.1186/1745-6215-15-65
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author Angwenyi, Vibian
Kamuya, Dorcas
Mwachiro, Dorothy
Kalama, Betty
Marsh, Vicki
Njuguna, Patricia
Molyneux, Sassy
author_facet Angwenyi, Vibian
Kamuya, Dorcas
Mwachiro, Dorothy
Kalama, Betty
Marsh, Vicki
Njuguna, Patricia
Molyneux, Sassy
author_sort Angwenyi, Vibian
collection PubMed
description BACKGROUND: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya. METHODS: Social scientists independent of the trial held in-depth individual interviews with trial researchers (n = 5), community leaders (n = 8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n = 6) and facility staff (n = 2). We conducted a survey of participating households (n = 200) and observed over 150 CE activities. RESULTS: The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants’ parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved. CONCLUSION: The trial teams’ goals for CE were relatively clear from the outset. Other actors’ hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors’ intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges minimized or avoided. TRIAL REGISTRATION: ClinicalTrials.gov NCT00866619 (registration 19-Mar-2009).
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spelling pubmed-39740492014-04-04 Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya Angwenyi, Vibian Kamuya, Dorcas Mwachiro, Dorothy Kalama, Betty Marsh, Vicki Njuguna, Patricia Molyneux, Sassy Trials Research BACKGROUND: Community engagement (CE) is increasingly promoted for biomedical research conducted in resource poor settings for both intrinsic and instrumental purposes. Given the potential importance of CE, but also complexities and possibility of unexpected negative outcomes, there is need for more documentation of CE processes in practice. We share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya. METHODS: Social scientists independent of the trial held in-depth individual interviews with trial researchers (n = 5), community leaders (n = 8) and parents (15 with enrolled children and 4 without); and group discussions with fieldworkers (n = 6) and facility staff (n = 2). We conducted a survey of participating households (n = 200) and observed over 150 CE activities. RESULTS: The overall CE plan was similar across the three study sites, although less community-based information in site C. Majority perceived CE activities to clear pre-existing concerns and misconceptions; increase visibility, awareness of and trust in trial staff. Challenges included: some community leaders attempting to exert pressure on people to enrol; local wording in information sheets and consent forms feeding into serious anxieties about the trial; and concerns about reduced CE over time. Negative effects of these challenges were mitigated through changes to on-going CE activities, and final information sharing and consent being conducted individually by trained clinical staff. One year after enrolment, 31% (n = 62) of participants’ parents reported malaria prevention as the main aim of the activities their children were involved in, and 93% wanted their children to remain involved. CONCLUSION: The trial teams’ goals for CE were relatively clear from the outset. Other actors’ hopes and expectations (like higher allowances and future employment) were not openly discussed, but emerged over the course of engagements. Encouraging open discussion of all actors’ intentions and goals from the outset takes time, risks raising expectations that cannot be met, and is complex. However, doing so in future similar trials may allow successes here to be built upon, and some challenges minimized or avoided. TRIAL REGISTRATION: ClinicalTrials.gov NCT00866619 (registration 19-Mar-2009). BioMed Central 2014-02-25 /pmc/articles/PMC3974049/ /pubmed/24565019 http://dx.doi.org/10.1186/1745-6215-15-65 Text en Copyright © 2014 Angwenyi et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
spellingShingle Research
Angwenyi, Vibian
Kamuya, Dorcas
Mwachiro, Dorothy
Kalama, Betty
Marsh, Vicki
Njuguna, Patricia
Molyneux, Sassy
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title_full Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title_fullStr Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title_full_unstemmed Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title_short Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
title_sort complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in kilifi, kenya
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3974049/
https://www.ncbi.nlm.nih.gov/pubmed/24565019
http://dx.doi.org/10.1186/1745-6215-15-65
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