Clinical trial NCT04912284: Africa COVID-19 Vaccine Hesitancy
Official title: Africa COVID-19 Vaccine Hesitancy: a Multi-country Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Vaccine hesitancy
Vaccines
West Africa
Lead sponsor: Bernhard Nocht Institute for Tropical Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Institut de Recherche en Sciences de la Sante, Burkina Faso
name: University of Bamako
name: Cheikh Anta Diop University, Senegal
name: University of Sierra Leone
name: Gamal Abdel Nasser University of Conakry
First posted: 2021-06-03
Enrollment: 4977
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of vaccine hesitancy
timeFrame: 1 month
Secondary outcomes:
measure: Factors influencing vaccine hesitancy
timeFrame: 1 month
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Henri Gautier Ouedragogo
city: Conakry
country: Guinea
facility: Alpha Mahmoud Barry
city: Bamako
country: Mali
facility: Seydou Doumbia
city: Dakar
country: Senegal
facility: Sylvain Faye
city: Freetown
country: Sierra Leone
facility: Abdul Mbawah
Study officials:
affiliation: Bernhard Nocht Institute for Tropical Medicine
name: Daniela Fusco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ouagadougu
name: Henri Gautier Ouedraogo, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Santé Plus
name: Alpha Mahmoud Barry, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bamako
name: Seydou Doumbia, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheikh Anta Diop University, Senegal
name: Sylvain Faye, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Freetown
name: Abdullah Mbawah, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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. No abstract available.
citation: 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.
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.
citation: Faye SLB, Krumkamp R, Doumbia S, Tounkara M, Strauss R, Ouedraogo HG, Sagna T, Barry AM, Mbawah AK, Doumbia CO, Diouf S, Cisse K, Harding M, Donven P, May J, Puradiredja DI, Fusco D; ACHES consortium. Factors influencing hesitancy towards adult and child COVID-19 vaccines in rural and urban West Africa: a cross-sectional study. BMJ Open. 2022 Apr 13;12(4):e059138. doi: 10.1136/bmjopen-2021-059138.