Analyses of acceptance (intention to receive, time frame before going to receive, uptake, and hesitancy) and the factors that influence the acceptance of COVID-19 vaccination among community members and health workers in Ebonyi state in Nigeria
| ISRCTN | ISRCTN16735844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16735844 |
- Submission date
- 05/03/2022
- Registration date
- 16/03/2022
- Last edited
- 13/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Coronavirus disease 2019 (COVID-19) is a very serious disease that started at the end of 2019. By 3rd January 2022, COVID-19 had affected more than 346 million people and killed over 5.5 million people across the world. By 26th January 2022, it has affected about 252,000 people and killed about 3100 people in Nigeria. It has also affected the economy of many countries. COVID-19 can be controlled by strategies like avoiding crowds, use of face masks, frequent hand washing with soap and running water, and frequent use of alcoholic hand sanitisers. However, the easiest and most reliable way to control COVID-19 is likely by vaccinating people with a COVID-19 vaccine. COVID-19 vaccination reduces the chance of getting COVID-19, reduces the seriousness of the disease, and also reduces the chance of dying from COVID-19. COVID-19 vaccination offers the safest, surest, and fastest way of protecting the public from COVID-19 and this can be so when all categories of people including adults and children are vaccinated. This is so because COVID-19 can affect all categories of people.
COVID-19 vaccination started in Nigeria in March 2021 and the Nigerian government and international partners are making COVID-19 vaccination more available for the people in Nigeria. However, the problem now is that contrary to what was expected, the percentage of people who have received COVID-19 vaccination is still very low in Ebonyi state and in Nigeria as a whole. This may be partly due to the fact that many people, including health workers, do not want to accept the vaccination.
This study aims to find out how many of the community members and health workers in Ebonyi state accept COVID-19 vaccination. That is, how many have received the vaccination, how many are planning to receive the vaccination, and how long they think it will take before they go and receive it. This study also wants to find out about the factors that influence whether people accept COVID-19 vaccination or not. The findings from this study will help the Ebonyi state and Nigerian government as they are planning how to increase the percentage of community members and health workers who accept and then receive COVID-19 vaccination.
Who can participate?
1. Community members who are aged 15 years and above in villages (or communities) which are very close to primary health care centres where they provide health care for pregnant women and children including routine childhood immunisation
2. Health workers who are working or living in Ebonyi state
What does the study involve?
28 villages or communities will be randomly selected. In each of the villages selected, all households will be visited and all persons aged 15 years and above, who accept to be interviewed, will be asked whether they have received COVID-19 vaccination. Those that have not received COVID-19 vaccination will be asked whether they plan to receive it. Those that plan to receive COVID-19 vaccination will be asked how long they think it will take before they go and receive it. All the health workers in Ebonyi state who accept to be interviewed will be asked the same questions. Some community will be asked to discuss COVID-19 and COVID-19 vaccination and to give their opinion about the factors that influence whether people accept and receive COVID-19 vaccination. Some health workers will also be asked to discuss COVID-19 and COVID-19 vaccination and to give their opinion about the factors that influence whether health workers accept and receive COVID-19 vaccination.
What are the possible benefits and risks of participating?
There will be no immediate or direct benefit to participants. The potential benefit is improvement in COVID-19 vaccination policy on how to increase the percentage of people who have received COVID-19 vaccination in order to prevent people from getting and dying from COVID-19 in Ebonyi state and Nigeria. There are no obvious or anticipated risks in participating in this study.
Where is the study run from?
Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) (Nigeria)
When is the study starting and how long is it expected to run for?
May 2021 to May 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Ugwu I. Omale
omaleiu@gmail.com
Contact information
Principal Investigator
Department of Community Medicine
Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA)
Ebonyi State
Abakaliki
480
Nigeria
 ORCID ID |
0000-0001-6586-8992 |
|---|---|
| Phone | +234 (0)7035094245 |
| omaleiu@gmail.com |
Study information
| Study design | Observational cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | COVID-19 vaccination acceptance among community members and health workers in Ebonyi state, Nigeria: a concurrent-independent mixed method analyses of intention to receive, timeliness of the intention to receive, uptake, and hesitancy to COVID-19 vaccination and the determinants |
| Study objectives | Current study hypothesis as of 21/04/2022: The primary hypotheses include: 1. Strong COVID-19 experience and perception increases COVID-19 vaccination acceptance (increases the intention to receive, timeliness of the intention to receive, and uptake and reduces hesitancy) compared with not strong COVID-19 experience and perception 2. Increase in COVID-19 experiences and perceptions score increases COVID-19 vaccination acceptance 3. Good COVID-19 vaccination expectation and perception increases COVID-19 vaccination acceptance compared with poor COVID-19 vaccination expectation and perception 4. Increase in COVID-19 vaccination expectations and perceptions score increases COVID-19 vaccination acceptance 5. Acceptance factor (COVID-19 risk-COVID-19 vaccination benefit perception or disease risk-remedy benefit perception [DR-RB or DRRB perception]) is significantly associated with COVID-19 vaccination acceptance 6. Positive COVID-19 vaccination process experience and perception (positive availability/access factor) increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination compared with negative COVID-19 vaccination process experience and perception (negative availability/access factor) 7. Increase in COVID-19 vaccination process experiences and perceptions score increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination 8. Acceptance-availability/access factor is significantly associated with the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination 9. Increase in acceptance factor score increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination compared with increase in availability/access factor score 10. The positive categories of COVID-19 experiences and perceptions, COVID-19 vaccination expectations and perceptions, and COVID-19 vaccination process experiences and perceptions respectively increase COVID-19 vaccination acceptance compared with the negative categories The secondary hypotheses include: 1. Knowledge, attitude, and practices about COVID-19 are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; and COVID-19 vaccination process experiences and perceptions 2. Sources of information about COVID-19 are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; and knowledge, attitude, and practices about COVID-19 3. Sociodemographic characteristics are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; knowledge, attitude, and practices about COVID-19; and sources of information about COVID-19 4. Professional or work-related attributes of health workers are significantly associated with: COVID-19 vaccination acceptance, COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; knowledge, attitude, and practices about COVID-19; and sources of information about COVID-19 ____________ Previous study hypothesis: The primary hypotheses include: 1. Strong COVID-19 experience and perception increases COVID-19 vaccination acceptance (increases the intention to receive, timeliness of the intention to receive, and uptake and reduces hesitancy) compared with not strong COVID-19 experience and perception 2. Increase in COVID-19 experiences and perceptions score increases COVID-19 vaccination acceptance 3. Good COVID-19 vaccination expectation and perception increases COVID-19 vaccination acceptance compared with poor COVID-19 vaccination expectation and perception 4. Increase in COVID-19 vaccination expectations and perceptions score increases COVID-19 vaccination acceptance 5. Acceptance factor (COVID-19 risk-COVID-19 vaccination benefit perception or disease risk-remedy benefit perception [DR-RB or DRRB perception]) is significantly associated with COVID-19 vaccination acceptance 6. Positive COVID-19 vaccination process experience and perception (positive availability/access factor) increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination compared with negative COVID-19 vaccination process experience and perception (negative availability/access factor) 7. Increase in COVID-19 vaccination process experiences and perceptions score increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination 8. Acceptance-availability/access factor is significantly associated with the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination 9. Increase in acceptance factor score increases the intention to receive, timeliness of the intention to receive, and uptake of COVID-19 vaccination compared with increase in availability/access factor score The secondary hypotheses include: 1. Knowledge, attitude, and practices about COVID-19 are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; and COVID-19 vaccination process experiences and perceptions 2. Sources of information about COVID-19 are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; and knowledge, attitude, and practices about COVID-19 3. Sociodemographic characteristics are significantly associated with: COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; knowledge, attitude, and practices about COVID-19; and sources of information about COVID-19 4. Professional or work-related attributes of health workers are significantly associated with: COVID-19 vaccination acceptance, COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions; knowledge, attitude, and practices about COVID-19; and sources of information about COVID-19 |
| Ethics approval(s) | 1. Approved 15/01/2022, Ebonyi State Health Research and Ethics Committee (Ebonyi State Ministry of Health, Block 5, New Secretariat Complex, Centenary City, Abakaliki, Ebonyi State, Nigeria; +234 (0)9065211521; ebonyistateministryofhealth@gmail.com), ref: EBSHREC/15/01/2022-02/01/2023 2. Approved 17/02/2022, Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki (Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA), Ebonyi State, Nigeria; +234 (0)8039558074; enquires@aefutha.gov.ng), ref: AE-FUTHA/REC/VOL3/2022/004 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Analytical cross-sectional survey with a concurrent-independent mixed data collection and data analysis and interpretation method. Quantitative data will be measured through a community member survey and a health worker survey at a single timepoint. Qualitative data will be measured through focus group discussions (FGDs) with community members and FGDs with health workers at a single timepoint. |
| Intervention type | Other |
| Primary outcome measure | The intention to receive, timeliness of the intention to receive, uptake, and hesitancy to COVID-19 vaccination measured using a population-based household survey and a health worker survey at a single timepoint |
| Secondary outcome measures | Measured using a population-based household survey and a health worker survey at a single timepoint: 1. COVID-19 experiences and perceptions 2. COVID-19 vaccination expectations and perceptions 3. COVID-19 vaccination process experiences and perceptions 4. Knowledge of COVID-19 5. Attitude towards COVID-19 and COVID-19 vaccination 6. Practices about COVID-19 7. Main source and most trusted source of information about COVID-19 |
| Overall study start date | 06/05/2021 |
| Completion date | 09/05/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 28 clusters, all eligible community members per cluster, all eligible health workers in Ebonyi state: about 10,000 community members and about 900 health workers |
| Total final enrolment | 12101 |
| Key inclusion criteria | Clusters (a cluster is a geographical community (village(s) or settlement(s)) which is the immediate catchment area of a primary health care (PHC) centre): 1. Having at least 200 households or a population of 1000 people 2. The PHC centre is providing basic maternal and child health care services including routine childhood immunisation 3. Can be easily accessed with a car 4. The cluster head gives verbal consent/permission Community members: 1. Aged 15 years and above 2. Gives verbal consent or assent 3. Have resided in the community for at least one year (for the focus group discussions) Health workers (both clinical and non-clinical staff in public and private health care sectors): 1. Working or living in Ebonyi state 2. Gives verbal consent 3. Have at least 1 year of working experience (for the focus group discussions) |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 12/03/2022 |
| Date of final enrolment | 09/05/2022 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
-
480
Nigeria
Sponsor information
Hospital/treatment centre
Ebonyi State
Abakaliki
480
Nigeria
| Phone | +234 (0)8037468896 |
|---|---|
| drewah08@yahoo.com |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Study results will be reported at local, national and international levels and in high-impact peer-reviewed journals. The study protocol will be submitted for consideration for publication in a high-impact peer-reviewed journal before commencement of recruitment of study participants. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 15/12/2022 | 16/12/2022 | Yes | No | |
| Results article | 12/07/2023 | 13/07/2023 | Yes | No |
Editorial Notes
13/07/2023: Publication reference added.
15/03/2023: Total final enrolment added.
16/12/2022: Publication reference added.
21/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 24/04/2022 to 09/05/2022.
2. The overall trial end date has been changed from 24/04/2022 to 09/05/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 30/06/2022 to 30/07/2022.
4. The study hypothesis has been updated.
18/03/2022: Please note that the trial was prospectively registered on 10/03/2022 but the publication of the trial record was delayed until 16/03/2022 due to a technical error. No changes were made to the trial record between these dates.
08/03/2022: Trial's existence confirmed by the Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki.
