Covid19ACHESNCT04912284
Africa COVID-19 Vaccine Hesitancy
An observational study of Covid19, run by Bernhard Nocht Institute for Tropical Medicine at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 4,977 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 5 May 2021to 6 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: 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.
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.
- 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
- 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.
- Conditions
- Covid19
- Keywords
- Vaccine hesitancy, Vaccines, West Africa
- Medical subject headings
- COVID-19, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General population | Questionnaire administered to adult population | |
| Health care workers | Questionnaire administered to adult health care workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start5 May 2021
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernhard Nocht Institute for Tropical Medicine
- Sponsor type
- Other government
- 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
- Investigators
- Daniela Fusco, PhD, Principal investigator, Bernhard Nocht Institute for Tropical MedicineHenri Gautier Ouedraogo, Prof, Principal investigator, University of OuagadouguAlpha Mahmoud Barry, Dr, Principal investigator, Santé PlusSeydou Doumbia, Prof, Principal investigator, University of BamakoSylvain Faye, Prof, Principal investigator, Cheikh Anta Diop University, SenegalAbdullah Mbawah, Dr, Principal investigator, University of Freetown
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912284
- Sponsor's protocol ID
- 2021-10550-BO-ff
- Acronym
- ACHES
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 25896383Lazarus 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.
PubMed 33082575Schwarzinger 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 33556325Samarasekera 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 33639125Dada 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 31829223Larson 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 25896384Di Meglio F, Lhomme E, Ouedraogo HG, Barry AM, Doumbia S, Faye SL, Mbawah AK, Sagna T, Tounkara M, Strauss R, Doumbia CO, Diouf S, Cisse K, May J, Puradiredja DI, Fusco D. Variations in COVID-19 vaccine hesitancy over time: a serial cross-sectional study in five West African countries. BMJ Open. 2024 Nov 7;14(11):e083766. doi: 10.1136/bmjopen-2023-083766.
PubMed 39510778Faye 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Africa COVID-19 Vaccine Hesitancy: a Multi-country Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04912284
- Acronym / sponsor ID
- ACHES / 2021-10550-BO-ff
- Conditions
- Covid19
- Keywords
- Vaccine hesitancy, Vaccines, West Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,977 participants (actual)
- Lead sponsor
- Bernhard Nocht Institute for Tropical MedicineOther government
- 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
- Study start
- 5 May 2021 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | –Questionnaire administered to adult population |
| Health care workers | – | –Questionnaire administered to adult health care workers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of vaccine hesitancy
Time frame: 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 secondary outcome
Factors influencing vaccine hesitancy
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Background: PubMed 25896383MacDonald 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.
- Background: PubMed 33082575Lazarus 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.
- Background: PubMed 33556325Schwarzinger 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.
- Background: PubMed 33639125Samarasekera 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.
- Background: PubMed 31829223Dada 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.
- Background: PubMed 25896384Larson 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.
- Derived from this study: PubMed 39510778Di Meglio F, Lhomme E, Ouedraogo HG, Barry AM, Doumbia S, Faye SL, Mbawah AK, Sagna T, Tounkara M, Strauss R, Doumbia CO, Diouf S, Cisse K, May J, Puradiredja DI, Fusco D. Variations in COVID-19 vaccine hesitancy over time: a serial cross-sectional study in five West African countries. BMJ Open. 2024 Nov 7;14(11):e083766. doi: 10.1136/bmjopen-2023-083766.
- Derived from this study: PubMed 35418436Faye 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.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Bernhard Nocht Institute for Tropical Medicine at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Burkina Faso, Guinea, Mali, Senegal, Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of vaccine hesitancy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912284, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.