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

Lessons from biomedical HIV prevention research indicate that standard of prevention packages evolve over time, and require active engagement of stakeholders and community advocates to define packages accept to community members and trial participants. Using COVID-19 prevention research as an exampl...

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Main Authors: Moréniké Oluwátóyìn Foláyan, Karine Dubé, Nicaise Ndembi
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Public Health
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Online Access:https://www.frontiersin.org/articles/10.3389/fpubh.2024.1539840/full
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author Moréniké Oluwátóyìn Foláyan
Karine Dubé
Nicaise Ndembi
Nicaise Ndembi
author_facet Moréniké Oluwátóyìn Foláyan
Karine Dubé
Nicaise Ndembi
Nicaise Ndembi
author_sort Moréniké Oluwátóyìn Foláyan
collection DOAJ
description Lessons from biomedical HIV prevention research indicate that standard of prevention packages evolve over time, and require active engagement of stakeholders and community advocates to define packages accept to community members and trial participants. Using COVID-19 prevention research as an example, this paper discusses the reasons why a standard of prevention package must be defined for infectious diseases prevention research, what the minimum content of this package may be, the importance of stakeholder engagement in defining the package, the role of the government, and ethical considerations. As the experience from the HIV pandemic had shown, multiple ethics guidelines argue for a comprehensive standard of prevention package for biomedical HIV prevention trials that does not preclude the inclusion of newly developed HIV prevention tools including those experimental products listed for emergency use during health crisis. In the case of COVID-19, the standard of prevention package should include at a minimum, risk reduction counseling on physical distancing, provision of hand sanitizers, education on how to use available prevention tools, and provision for the possibility of vaccine-induced seropositivity. When pre-exposure prophylaxis studies are conducted for healthcare workers and home carers, personal protective equipment should be provided. Regional and country level regulatory provisions on these issues can provide critical guidance for research design and implementation.
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spelling doaj-art-74dcd7ca97aa44dd8b476c268062db142025-01-21T08:36:42ZengFrontiers Media S.A.Frontiers in Public Health2296-25652025-01-011210.3389/fpubh.2024.15398401539840Standard 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-19Moréniké Oluwátóyìn Foláyan0Karine Dubé1Nicaise Ndembi2Nicaise Ndembi3Department of Child Dental Health, Obafemi Awolowo University, Ile-Ife, NigeriaDivision of Infectious Diseases and Global Public Health, School of Medicine, University of California, San Diego, La Jolla, CA, United StatesDivision of Epidemiology and Prevention, Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD, United StatesAfrica Center for Disease Control and Prevention (Africa CDC), African Union Commission, Addis Ababa, EthiopiaLessons from biomedical HIV prevention research indicate that standard of prevention packages evolve over time, and require active engagement of stakeholders and community advocates to define packages accept to community members and trial participants. Using COVID-19 prevention research as an example, this paper discusses the reasons why a standard of prevention package must be defined for infectious diseases prevention research, what the minimum content of this package may be, the importance of stakeholder engagement in defining the package, the role of the government, and ethical considerations. As the experience from the HIV pandemic had shown, multiple ethics guidelines argue for a comprehensive standard of prevention package for biomedical HIV prevention trials that does not preclude the inclusion of newly developed HIV prevention tools including those experimental products listed for emergency use during health crisis. In the case of COVID-19, the standard of prevention package should include at a minimum, risk reduction counseling on physical distancing, provision of hand sanitizers, education on how to use available prevention tools, and provision for the possibility of vaccine-induced seropositivity. When pre-exposure prophylaxis studies are conducted for healthcare workers and home carers, personal protective equipment should be provided. Regional and country level regulatory provisions on these issues can provide critical guidance for research design and implementation.https://www.frontiersin.org/articles/10.3389/fpubh.2024.1539840/fullstandard of preventionHIV preventionpandemicsepidemicsoutbreaksinfectious diseases
spellingShingle Moréniké Oluwátóyìn Foláyan
Karine Dubé
Nicaise Ndembi
Nicaise Ndembi
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
standard of prevention
HIV prevention
pandemics
epidemics
outbreaks
infectious diseases
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic standard of prevention
HIV prevention
pandemics
epidemics
outbreaks
infectious diseases
url https://www.frontiersin.org/articles/10.3389/fpubh.2024.1539840/full
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