Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo.

Autor: Zola Matuvanga T; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Wilrijk, Belgium; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo. Electronic address: zola.matuvanga@unikin.ac.cd., Larivière Y; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Wilrijk, Belgium., Lemey G; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Wilrijk, Belgium., Isekah Osang'ir B; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Wilrijk, Belgium., Mariën J; Department of Biology, Evolutionairy Ecology group, University of Antwerp, Wilrijk, Belgium; Department of Biology, Royal Museum for Central Africa, Tervuren, Belgium., Milolo S; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Meta R; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Matangila J; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Maketa V; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Mitashi P; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Van Geertruyden JP; Global Health Institute, Department of Family Medicine and Population Health, University of Antwerp, Wilrijk, Belgium., Muhindo-Mavoko H; Tropical Medicine Department, University of Kinshasa, Kinshasa, Congo., Van Damme P; Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Wilrijk, Belgium.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2024 Jan 25; Vol. 42 (3), pp. 481-488. Date of Electronic Publication: 2023 Dec 31.
DOI: 10.1016/j.vaccine.2023.12.076
Abstrakt: Background: The long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants' retention and understanding of the trial information after two years of participation in a vaccine trial.
Methods: In total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC). Individual scores obtained from a questionnaire (test of understanding, TOU), specifically designed to assess the understanding of the consent at baseline, were collected before the clinical trial started and at one-year and two-year intervals.
Results: TOU scores were high in the beginning of the trial (median TOU = 10/10), but significantly decreased in both the first and second years following (median TOU = 8/10 in year 1 and median TOU = 9/10 in year 2, p-value < 0.0001). The decrease in scores was significantly higher among individuals with occupations requiring shorter education such as midwives (median TOU = 7/10 in year 1 and 8/10 in year 2, pvalue = 0.025). Furthermore, older participants exhibited poorer retention of information compared to younger individuals (median TOU = 8/10 vs 9/10, p-value = 0.007).
Conclusion: We observed a significant decline in the informational knowledge of informed consent, specifically in terms of basic knowledge on the study vaccine and trial procedures. As participant safety and understanding is a paramount ethical concern for researchers, it is crucial for participants to fully comprehend the study's objectives and potential risks. Therefore, our findings suggest the need for clinical researchers to re-explain participants to optimize the protection of their rights and wellbeing during the research.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Potential conflicts of interest All authors attest they meet the ICMJE criteria for authorship.
(Copyright © 2023. Published by Elsevier Ltd.)
Databáze: MEDLINE
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