ClinicalTrials.gg
CompletedNCT04912284ACHESUpdated Jun 21, 2021

Africa COVID-19 Vaccine Hesitancy

An observational study in Covid19, sponsored by Bernhard Nocht Institute for Tropical Medicine. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-21.

Sponsored by Bernhard Nocht Institute for Tropical Medicine · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
4,977
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

  1. 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
  1. 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.
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Conditions studied

  • Covid19

Keywords

  • Vaccine hesitancy
  • Vaccines
  • West Africa
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In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 4,977 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Bernhard Nocht Institute for Tropical Medicine is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

General population

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

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
4,977 participants (actual)
Patient registry
No

Groups and cohorts

  • General population

    Questionnaire administered to adult population

  • Health care workers

    Questionnaire administered to adult health care workers

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

Secondary outcomes

  1. 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

    Time frame: 1 month

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Study locations

5 sites
  • Henri Gautier Ouedragogo
    Ouagadougou, 7192, Burkina Faso
  • Alpha Mahmoud Barry
    Conakry, Guinea
  • Seydou Doumbia
    Bamako, Mali
  • Sylvain Faye
    Dakar, Senegal
  • Abdul Mbawah
    Freetown, Sierra Leone
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References and documents

Publications

  • 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. PubMed 25896383 ↗
  • 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 Feb;27(2):354. doi: 10.1038/s41591-020-01226-0. PubMed 33082575 ↗
  • 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. PubMed 33556325 ↗
  • 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. PubMed 33639125 ↗
  • 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. PubMed 31829223 ↗
  • 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. PubMed 25896384 ↗
  • 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. PubMed 35418436 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Jun 2021, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2021
First posted
Jun 3, 2021
StartActual
May 5, 2021
Primary completionActual
Jun 6, 2021
CompletionActual
Jun 6, 2021
Last update
Jun 21, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04912284
Lead sponsor
Bernhard Nocht Institute for Tropical Medicine
Collaborators
Institut de Recherche en Sciences de la Sante, Burkina Faso, University of Bamako, Cheikh Anta Diop University, Senegal, University of Sierra Leone, Gamal Abdel Nasser University of Conakry
Responsible party
Sponsor
First posted
Jun 3, 2021
Start date
May 5, 2021
Primary completion
Jun 6, 2021
Completion
Jun 6, 2021
Last update
Jun 21, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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