Africa COVID-19 Vaccine Hesitancy

Covid19 Clinical Trial

— ACHES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912284
• Other study ID #: 2021-10550-BO-ff
• Status: Completed
• Start date: May 5, 2021
• Est. completion date: June 6, 2021

Study information

• Verified date: June 2021
• Source: Bernhard Nocht Institute for Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4977
• Est. completion date: June 6, 2021
• Est. primary completion date: June 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Burkina Faso	Henri Gautier Ouedragogo	Ouagadougou
Guinea	Alpha Mahmoud Barry	Conakry
Mali	Seydou Doumbia	Bamako
Senegal	Sylvain Faye	Dakar
Sierra Leone	Abdul Mbawah	Freetown

Sponsors (6)

Lead Sponsor	Collaborator
Bernhard Nocht Institute for Tropical Medicine	Cheikh Anta Diop University, Senegal, Gamal Abdel Nasser University of Conakry, Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Bamako, University of Sierra Leone

Countries where clinical trial is conducted

Burkina Faso,  Guinea,  Mali,  Senegal,  Sierra Leone, 

References & Publications (6)

Dada S, McKay G, Mateus A, Lees S. Lessons learned from engaging communities for Ebola vaccine trials in Sierra Leone: reciprocity, relatability, relationships and respect (the four R's). BMC Public Health. 2019 Dec 11;19(1):1665. doi: 10.1186/s12889-019-7978-4. — View Citation

Larson HJ, Jarrett C, Schulz WS, Chaudhuri M, Zhou Y, Dube E, Schuster M, MacDonald NE, Wilson R; SAGE Working Group on Vaccine Hesitancy. Measuring vaccine hesitancy: The development of a survey tool. Vaccine. 2015 Aug 14;33(34):4165-75. doi: 10.1016/j.vaccine.2015.04.037. Epub 2015 Apr 18. — View Citation

Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K, Kimball S, El-Mohandes A. A global survey of potential acceptance of a COVID-19 vaccine. Nat Med. 2021 Feb;27(2):225-228. doi: 10.1038/s41591-020-1124-9. Epub 2020 Oct 20. Erratum in: Nat Med. 2021 Jan 11;:. — View Citation

MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17. — View Citation

Samarasekera U. Feelings towards COVID-19 vaccination in Africa. Lancet Infect Dis. 2021 Mar;21(3):324. doi: 10.1016/S1473-3099(21)00082-7. — View Citation

Schwarzinger M, Watson V, Arwidson P, Alla F, Luchini S. COVID-19 vaccine hesitancy in a representative working-age population in France: a survey experiment based on vaccine characteristics. Lancet Public Health. 2021 Apr;6(4):e210-e221. doi: 10.1016/S2468-2667(21)00012-8. Epub 2021 Feb 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of vaccine hesitancy	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
Secondary	Factors influencing vaccine hesitancy	To explore factors influencing COVID-19 vaccination hesitancy among the general population and health care workers in urban and rural Africa	1 month