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Africa COVID-19 Vaccine Hesitancy (ACHES)

16 de junio de 2021 actualizado por: Bernhard Nocht Institute for Tropical Medicine

Africa COVID-19 Vaccine Hesitancy: a Multi-country Cross-sectional Study

Vaccine hesitancy is defined by the WHO's Strategic Advisory Group of Experts on Immunization as a 'delay in acceptance or refusal of vaccination despite availability of vaccination services'. This varies in form and intensity based on when and where it occurs and what vaccine is involved. Several prophylactic vaccines against COVID-19 are currently available. As the world is beginning the roll-out the first approved vaccines, little is known about people's potential acceptance of a COVID-19 vaccine in most of the African countries. ACHES (African COVID -19Vaccine Hesitancy) is an observational study aimed at measuring COVID-19 vaccine hesitancy in five west African countries and exploring causes behind the hesitancy with the main objective of informing guidelines for the proficient roll-out of the vaccines in the region.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

Coronavirus disease 2019 (COVID-19) was declared a Public Health Emergency of International Concern by the World Health Organization (WHO) in March 2020. Although African countries seem to have weathered the pandemic relatively well so far, with fewer than one confirmed case for every thousand people and around 50,000 death, the African continent has now officially over two million- COVID-19- case threshold.

In 2015, WHO's Strategic Advisory Group of Experts on Immunization defined vaccine hesitancy as a 'delay in acceptance or refusal of vaccination despite availability of vaccination services', which can vary in form and intensity based on when and where it occurs and what vaccine is involved. Several prophylactic vaccines against COVID-19 are currently in development. As the world is beginning the roll-out the first approved vaccines, little is known about people's potential acceptance of a COVID-19 vaccine in most of the African countries. A recent study published in Nature provides results on the acceptability of vaccines in 19 of the 35 hardest hit countries worldwide. South Africa was the only African country included in the survey. An additional survey conducted in 15 African countries between August and December 2020, reveals that the majority of Africans would take a safe and effective vaccine. Nevertheless, vaccine hesitancy towards COVID-19 vaccines evolves over-time. In this view, it is crucial to investigate in depth barriers and facilitators influencing vaccine hesitancy/acceptability within African population.

During the last decade several initiatives have emerged that aim at improving vaccine coverage and acceptability across the African continent. A noteworthy example is the Francophone African Civil Society Organizations' Platform for Strengthening Health Systems and Immunization, which has been since 2015 supported by GAVI (Global Alliance for Vaccines and Immunisation). OAFRESS encourages activities among francophone African members, with the primary objective of reinforcing capacities and coordinating strategies among these countries. The last West African Ebola epidemic demonstrated the importance of engaging communities in order to promote vaccine acceptability. The three most hit countries, Guinea, Sierra Leone, and Liberia, worked together and invested in research and campaigns to identify and address barriers and facilitators of vaccine acceptance, which informed both clinical vaccine studies and roll-out strategies.

In order to promote the equitable and prompt roll-out of the COVID-19 vaccine worldwide, as the COVAX initiative strives for, factors influencing vaccine hesitancy in low and middle-income countries need to be investigated more thoroughly. The request for a first roll-out of the vaccines in eligible countries was to be submitted by December 7, 2020. Many of the eligible African countries have placed the order to receive the vaccines, which are already being deployed within these first months of 2021. Country and population preparedness are crucial to making the roll-out a success.

2. Study Objectives 2.1 Overall objective To investigate COVID-19 vaccine hesitancy among five African countries to inform effective context-specific public health strategies for roll-out of vaccination.

2.2 Primary objectives • To describe and compare levels of COVID-19 vaccine hesitancy among the general population and health care workers in rural and urban settings across African countries

2.3 Secondary objectives

• To explore factors influencing COVID-19 vaccination hesitancy among the general population and health care workers in urban and rural Africa

3. Methodology 3.1 Study design A cross-sectional survey will be conducted in five African countries. A core study will be implemented in five countries, other countries will enter the study as budget will become available. Study participants will be selected among the general population aged older than 18 and health care workers. Sample sizes have been calculated separately for these two groups.

Tipo de estudio

De observación

Inscripción (Actual)

4977

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Ouagadougou, Burkina Faso, 7192
        • Henri Gautier Ouedragogo
      • Conakry, Guinea
        • Alpha Mahmoud Barry
      • Bamako, Malí
        • Seydou Doumbia
      • Dakar, Senegal
        • Sylvain Faye
      • Freetown, Sierra Leona
        • Abdul Mbawah

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

The general population will be selected in the capital and a rural area (around the capital) from each country. Approximately 5 clusters per area will be considered. The interviews will be house hold based.

Health workers will be interviewed in facilities located in the study area and selected by the local study coordinator. Only people who have direct contact with patients will be considered for the analysis. To select study participants, staff lists including social workers from each facility will be used to randomly select people to be interviewed.

Descripción

Inclusion Criteria:

General population

  • Be at least 18 years of age, be willing and able to provide written informed consent AND

Health professionals

  • To be health professionals working in health care institutions at all levels of care for the Ministry of Health (MoH)
  • freely consent to participate in the study

Exclusion Criteria:

  • All minors (<18)
  • All individuals who do not meet the inclusion criteria listed above and those who are not willing to give written informed consent for participation in this research

In Senegal

  • All those already vaccinated or being offered a vaccination for COVID-19 and refused and/or delayed the vaccination

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
General population
Questionnaire administered to adult population
Health care workers
Questionnaire administered to adult health care workers

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Frequency of vaccine hesitancy
Periodo de tiempo: 1 month
To describe and compare levels of COVID-19 vaccine hesitancy among the general population and health care workers in rural and urban settings across different African countries
1 month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Factors influencing vaccine hesitancy
Periodo de tiempo: 1 month
To explore factors influencing COVID-19 vaccination hesitancy among the general population and health care workers in urban and rural Africa
1 month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Daniela Fusco, PhD, Bernhard Nocht Institute for Tropical Medicine
  • Investigador principal: Henri Gautier Ouedraogo, Prof, University of Ouagadougu
  • Investigador principal: Alpha Mahmoud Barry, Dr, Santé Plus
  • Investigador principal: Seydou Doumbia, Prof, University of Bamako
  • Investigador principal: Sylvain Faye, Prof, Cheikh Anta Diop University, Senegal
  • Investigador principal: Abdullah Mbawah, Dr, University of Freetown

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de mayo de 2021

Finalización primaria (Actual)

6 de junio de 2021

Finalización del estudio (Actual)

6 de junio de 2021

Fechas de registro del estudio

Enviado por primera vez

31 de mayo de 2021

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2021

Publicado por primera vez (Actual)

3 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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