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Introduction The COVID-19 pandemic has gravely affected the lives and economies of the global population including Nigeria. The attainment of herd immunity through mass COVID-19 vaccination is the foremost control strategy, however, the deployments of COVID-19 vaccinations are facing challenges of non-acceptance. Despite the efforts of the Nigerian government and COVAX facility in making COVID-19 vaccination more available/accessible, the vaccination rate remains unexpectedly very low in Nigeria/Ebonyi state. Therefore, it is important to investigate the acceptability of COVID-19 vaccination to elucidate the explanations for the very low coverage rate. This study aims to evaluate/explore COVID-19 vaccination acceptance and the determinants among community members and health workers in Ebonyi state, Nigeria. Methods and analyses The study is an analytical cross-sectional survey with a concurrent-independent mixed method design. Quantitative data will be collected from all consenting/assenting community members aged 15 years and above, in 28 randomly selected geographical clusters, through structured interviewer-administered questionnaire household survey using KoBoCollect installed in android devices. Quantitative data will be collected from all consenting health workers, selected via convenience and snowball techniques, through structured self-administered questionnaire survey distributed via WhatsApp and interviewer-administered survey using KoBoCollect installed in android devices. Qualitative data will be collected from purposively selected community members and health workers through focus group discussions. Quantitative analyses will involve descriptive statistics, generalised estimating equations (for community members data) and generalised linear model (for health workers data). Qualitative analyses will employ the thematic approach. Ethics and dissemination Ethical approval for this study was obtained from the Ebonyi State Health Research and Ethics Committee (EBSHREC/15/01/2022-02/01/2023) and Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki (14/12/2021-17/02/2022), and verbal consent will be obtained from participants. Study findings will be reported at local, national and international levels as appropriate. Trial registration number ISRCTN16735844.
The study is an analytical cross-sectional survey with a concurrent-independent mixed data collection and data analysis and interpretation method. In this design, the quantitative and qualitative aspects of the study will be implemented simultaneously and independently of each other.80 The study protocol development was guided by the Standard Protocol Items: Recommendations for Interventional Trials 2013 checklist and the Strengthening the Reporting of Observational Studies in Epidemiology 2007 checklist for cross-sectional studies. The study is planned to be implemented between March and April 2022, in Ebonyi state which is located in south-eastern geopolitical zone of Nigeria with land area of 5953 km2. The population of the state was projected to be 3 313 229 in 2021 based on the 2006 national census figure and a growth rate of 2.8% and christianity is the most practiced religion. Ebonyi state has 13 Local Government Areas (LGAs) including the state capital (Abakaliki LGA) and 171 political wards.81 Each LGA is made up of political wards and autonomous communities. Each autonomous community is made up of larger villages called autonomous villages, which consist of smaller villages or settlements. Each village/settlement has a head or traditional leader. Most parts of Ebonyi state are rural and there are only six towns (urban or semiurban areas), five of which are LGAs capitals with the adjoining areas.82 The federal ministry of health (FMOH) and its agencies provide the overarching guidance and policy framework for public and private health service delivery in all states in Nigeria including Ebonyi state. The FMOH provides health services in the state through tertiary health facilities, while the state ministry of health (SMOH) provides health service through secondary health facilities (general hospitals). The SMOH and the state primary healthcare development agency (SPHCDA) provide healthcare in the local governments through primary healthcare (PHC) facilities. There is at least one PHC centre in each political ward. The national primary healthcare development agency (NPHCDA) provides policy guidance and coordination for immunisation/vaccination services in all states in Nigeria including Ebonyi state. The NPHCDA provides vaccines and related products while the SMOH and SPHCDA coordinates the implementation of immunisation/vaccination service delivery in the state (and LGAs) through the tertiary, secondary, and PHC facilities. The participants include clusters, the community members within clusters and health workers in Ebonyi state. A cluster in this study is a geographical community (village(s)/settlement(s)), which is the immediate catchment area of a PHC centre. Eligible clusters for inclusion in the study are those with at least 200 households or a population of 1000 people, whose PHC centres are providing basic maternal and child healthcare services, including routine childhood immunisation, which can be easily accessed with a car, and where the cluster heads give verbal consent/permission. In each of the selected clusters, community members aged 15 years and above who give verbal consent/assent will be eligible to participate in a population-based household survey. Health workers (both clinical and non-clinical staff) in public and private healthcare sectors, including the patent medicine vendors, who work or live in Ebonyi state and give verbal consent, will be eligible to participate in a health worker survey. Community members aged 15 years and above who have resided in the community for at least 1 year and who give verbal consent/assent will be eligible to participate in community-based focus group discussions (FGDs) while health workers (both clinical and non-clinical staff), who work or live in Ebonyi state, have at least 1 year of working experience and give verbal consent will be eligible to participate in health worker-based FGDs. The independent factors among community members and health workers (see table 1) are almost the same with few differences, which include: occupation, monthly income and residence among the community members; and professional or work category/cadre, years of working experience, place of work and level of place of work among the health workers. The independent factors are listed under nine headings labelled A–I: COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions; COVID-19 vaccination process experiences and perceptions (availability/access factor); Acceptance factor (COVID-19 risk-COVID-19 vaccination benefit perception); Acceptance-availability/access factor; Knowledge, attitude, and practice about COVID-19; Source of information about COVID-19; Sociodemographic characteristics; and Professional or work-related attributes. These three factors—COVID-19 experiences and perceptions; COVID-19 vaccination expectations and perceptions and COVID-19 vaccination process experiences and perceptions—will be respectively measured using eight, five and five questionnaire items each having five categories grouped into positive and negative and scored from 0 to 4 as depicted in table 1. The scoring will create three new continuous variables, including COVID-19 experiences and perceptions score (ranging from 0 to 32 for each participant); COVID-19 vaccination expectations and perceptions score (ranging from 0 to 20) and COVID-19 vaccination process experiences and perceptions score (ranging from 0 to 20). These continuous variables will then be graded on a two-level scale such that scores ≥50% of the total versus <50% will, respectively, be considered to be: strong versus not strong COVID-19 experience and perception; good versus poor COVID-19 vaccination expectation and perception and positive versus negative COVID-19 vaccination process experience and perception. Acceptance factor will be created as the combination of COVID-19 experiences and perceptions plus COVID-19 vaccination expectations and perceptions and defined as COVID-19 risk-COVID-19 vaccination benefit perception (disease risk-remedy benefit perception (DR-RB/DRRB perception)) Acceptance factor will be in contrast to availability/access factor (COVID-19 vaccination process experience and perception). Acceptance-availability/access factor will be created as the combination of acceptance and availability/access factors. Acceptance factor score (ranging from 0 to 52 for each participant as the sum of disease-risk perception score (0–32) and remedy-benefit perception score (0–20)) and availability/access factor score (ranging from 0 to 20) will be converted to percentages of the maximum attainable score for each participant, so that the power of acceptance factor and availability/access factor in predicting COVID-19 vaccination acceptance can be compared by comparing how unit increase in the percentage scores (percentage point increase) affects COVID-19 vaccination acceptance. The predictive power of disease-risk perception and remedy-benefit perception will also be compared using similar technique. Basic knowledge, attitude and practices about COVID-19 will be assessed, scored and categorised as stated in the legend of table 1. The outcome measures are as defined in table 2. The primary outcomes among community members and health workers include the intention to receive, timeliness of the intention to receive, uptake and hesitancy to COVID-19 vaccination. Hesitancy was conceptualised as: non-receipt of a vaccination that is really available and accessible and perceived to be available and accessible because one did not want to receive it and either intends to receive it at a later time (delay) or intends not to receive it at a later time (refusal). Outcome measures and their definitions *Interpersonal source includes family members/relatives/friends, other health workers, place of work, place of worship/religious forums; traditional media source includes television, radio, prints (newspaper/magazine)); Internet, social media and SMS source includes WhatsApp, Facebook, Internet sites, Bulk SMS/Text messages. Hesitancy to COVID-19 vaccination was measured among the unvaccinated based on the concepts of ‘non-acceptance factor’ and real or perceived ‘non-availability (non-access) factor’ and delay versus refusal was measured based on intention versus non-intention to receive among those who were hesitant (table 2). The secondary outcomes include COVID-19 experiences and perceptions, COVID-19 vaccination expectations and perceptions, COVID-19 vaccination process experiences and perceptions, knowledge of COVID-19, attitude towards COVID-19 and COVID-19 vaccination, practices about COVID-19 and main source and most trusted source of information about COVID-19 (table 2). Quantitative data will be measured through population-based household survey using structured community members' questionnaire (online supplemental file 1) and health workers survey using structured health workers' questionnaire (online supplemental file 2). The community members’ questionnaire and the health workers’ questionnaire are virtually the same except for the absence of identification section and the professional/work-related attributes in the sociodemographic section of the health workers' questionnaire. The questionnaire was designed with the guide of data published by other studies,12 34 42 47 the Report of the SAGE Working Group on Vaccine Hesitancy,18 the WHO vaccination coverage questionnaire83 and basic facts about COVID-19 on WHO website.84 The electronic versions of both questionnaires were programmed using the KoBoToolbox software and were pre-tested in non-participating clusters and among health workers who will later be exempted from the study. bmjopen-2022-061732supp001.pdf bmjopen-2022-061732supp002.pdf The community members’ questionnaire will be interviewer administered. The interviewers will administer the electronic questionnaire with KoBoCollect installed in their android phones or tablet devices. The interviewers will receive 2 days training on how to administer the electronic questionnaire. The training will include a detailed review and explanation of the questionnaire items, how to obtain consent from respondents, interview techniques, the translation of key words in the questionnaire to local language, household revisiting techniques and how to collect data and upload completed forms with KoBoCollect. During the household survey, all the households will be enumerated and household members aged 15 years and above in households where verbal consent is given by the heads of households will be enlisted and assigned unique numbers on a separate paper form before administering the anonymised electronic questionnaire. To enhance coverage and response, local residents who have good knowledge of the cluster environment will preferably be the interviewers, so that they can visit households when household members are expected to be around and revisit up to three times as necessary. The community members’ questionnaire has seven sections: identification (including cluster number, household number, participant number); sociodemographic characteristics; COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; basic knowledge of COVID-19; attitude towards COVID-19 and COVID-19 vaccination and practices about COVID-19 (online supplemental file 1). The health workers' questionnaire will be both self-administered and interviewer-administered. The web link for the electronic questionnaire will be distributed to health workers via social media platform such as WhatsApp. However, interviewers will administer the health workers questionnaire via KoBoCollect installed in android devices to health workers who do not have online contact and those living in remote areas with poor internet access. The health workers' questionnaire has six sections: Sociodemographic characteristics; COVID-19 vaccination acceptance; COVID-19 experiences and perceptions; Basic knowledge of COVID-19; Attitude towards COVID-19 and COVID-19 vaccination; and Practices about COVID-19 (online supplemental file 2). Qualitative data will be measured through FGDs with community members and health workers. A total of 20 FGDs with community members will be carried out across 10 clusters with two FGDs (one male-FGD and one female-FGD) per cluster. A total of 14 FGDs with health workers will be conducted, five with non-clinical staff and nine with clinical staff (five at PHC facilities and four at secondary/tertiary health facilities). The investigators will conduct the FGDs using FGD guide (online supplemental file 3) prepared in English and pre-tested in non-participating clusters and among some health workers who will later be exempted from the study. The FGD guides (online supplemental file 3) contain step-by-step instructions and both open-ended and more targeted questions designed to explore the participants’ perceptions about COVID-19, COVID-19 vaccine/vaccination, COVID-19 vaccination process, and the determinants of COVID-19 vaccination acceptance. bmjopen-2022-061732supp003.pdf Before commencement of each FGD, the investigators will collect background data of participants including age, sex, marital status, level of education, occupation or cadre and years of working experience as appropriate. The community members' FGDs will be conducted in local language and the health workers' FGDs in English. Each FGD will consist of 7–8 participants (comprising a moderator, a note taker and the respondents) and will last for about 45 min. The FGDs will be audio-recorded, the health workers FGDs will be transcribed and community members FGDs will be translated and transcribed verbatim into English. The skip logic and validation criteria in KoBoToolbox software were used when programming the electronic questionnaire to enhance the quality of data collection. To minimise the potential bias in assessing the association between COVID-19 and COVID-19 vaccination-related experiences and perceptions and uptake of COVID-19 vaccination, the questionnaire items on these factors are subdivided into two subgroups: ‘have not received COVID-19 vaccination’ and ‘have received COVID-19 vaccination’ and the items in each subgroup are framed differently, respectively, in present tense versus in past tense. For example, those whose response to a preceding question indicate that they have not received COVID-19 vaccination will subsequently respond to the questions: ‘How fearful are you that you may have very serious side-effects if you receive COVID-19 vaccination?’ ‘How fearful are you about getting COVID-19?’, etc. In contrast, those who have received COVID-19 vaccination will subsequently respond to the questions: ‘Regarding your experiences and perceptions before the day you received the first dose of COVID-19 vaccination: How fearful were you that you might have very serious side-effects if you received COVID-19 vaccination?’ ‘How fearful were you about getting COVID-19?’ To enhance the validity of the questionnaires, after the first drafts, there were several rounds of systematic review–discussion–correction–redrafting by the research team. During this iterative process, attention was paid to relevance of the questionnaire items to the study objectives and the logical flow and order, wording, framing, clarity and appropriateness of the questions. The validation process continued until the final version of the questionnaires which were then pretested. During the pretest, respondents’ understanding and interpretation of the items and the options, their response time to individual items and time taken to complete a questionnaire were assessed and the completed questionnaires were reviewed for any problems. Minor adjustments were made thereafter. The household interviewers will upload only completed anonymised questionnaires to the online survey records at the end of each day’s survey and the transmitted questionnaires will be reviewed for missing, incoherent and illogical data. Any identified error will immediately be communicated to the respective interviewers for correction by cross-checking with the respective respondents. The investigators will supervise the household survey interviewers and will revisit at least 20 eligible households per cluster with a specialised form of the survey questionnaire to double check on responses and coverage. Multiple submissions of the self-administered electronic questionnaire from a health worker on the same device and browser will be prevented by deploying the questionnaire through the online-only (once per respondent) option in KoBoToolbox. However, in any case where a health worker who has completed the questionnaire agrees to give the android phone to any coworker—who do not have android phone or online address but is willing to participate in the survey—to respond to the questionnaire, a web link for online-only (single submission) will be sent to such health worker. The data utility in Stata will be used to check for duplicated submissions (observations) and if found, only one will be kept, the duplicates will be deleted from the data set. Participation of study participants in the FGDs before the questionnaire surveys will be prevented. During the translation and transcribing of the community members FGDs, exact and meaning-based translation will be used. The FGD transcripts will be compared with the original recording to check for ‘accuracy’ before conducting analyses. Sample size is estimated using Stata/SE V.15·1 (Stata Corp, College Station, Texas). For the community members survey, assuming a conservative estimate of 50% for the primary outcome (the proportion of community members who have not received COVID-19 vaccination who intend (or plan) to receive COVID-19 vaccination that is available for them to receive) among the community members who have not strong COVID-19 experience and perception and 56% among those who have strong COVID-19 experience and perception, 80% power at 2.5% probability of type 1 error (to correct for multiple comparisons),85 2630 is the minimum total sample size required to detect the 6%-point difference in this primary outcome between both comparison groups. Allowance for 70% response rate will increase the sample size to 3758. To account for cluster sampling, 3758 is multiplied by a conservative estimate of design effect of 4 to give a final minimum total sample size of 15 032. As the clusters that will be selected to participate in the study are those with minimum population size of 1000 per cluster, and with 540 (54%) of the population expectedly falling withing the age group of 15 years and above,86 the study requires 28 clusters (15 032/540) for the community members survey. Using similar parameters, the health workers’ survey requires a minimum total sample size of 940 to detect a 10%-point difference in this primary outcome between both comparison groups (50% vs 60%). Because of the nature of the survey, such as the use of social media platforms for distribution of the (self-administered) questionnaire, the length of the questionnaire and the sampling technique (convenience and snowball), allowance for 50% acceptance rate to account for both non-response and incomplete response will increase the minimum total sample size for the health worker survey to 1880. Also, due to the nature of the survey, the 1880 is perhaps more of the number of health workers who will be targeted for distribution of the questionnaire rather than for selection to participate in the survey. Community members will be selected by stratified cluster sampling technique. The sampling frame will be the list of clusters obtained from the Ebonyi SMOH. The eligible clusters will be stratified into two: rural and urban/semiurban. A random sample of 21 clusters will be selected from the rural stratum and a random sample of seven clusters will be selected from the urban/semiurban stratum using the ‘sample’ command in Stata. This will give a 3:1 rural to urban ratio. If verbal consent/permission is not given by any of the selected cluster(s) head(s) before commencement of household survey, replacement cluster(s) will be selected from the remaining list of eligible clusters using the same technique. The study profile is shown in figure 2. In each of the selected clusters, all the households will be enumerated and all individuals aged 15 year and above in each household will be selected for the community members’ survey. About five to six eligible male and female community members, both those who have received and those who have not received COVID-19 vaccination, in 10 clusters, will be selected purposively for FGDs. Summary of study profile. Health workers will be selected by convenience and snowballing techniques. To increase acceptance rate, the research team will first make a physical and or phone contact with as many health workers as possible to invite them to participate in the survey and seek their consent and permission for the web link for the self-administered electronic questionnaire to be sent to them via online platforms. For those who give consent and permission, the address or phone number of their preferred online platform will be recorded and the web link for the questionnaire will be sent to their private online pages. They will be implored to forward the web link to other health workers that they know within the study area after they have completed the questionnaires. The research team will send the web link for the questionnaire to the online contacts (such as WhatsApp phone numbers) of as many eligible health workers as possible, including both private and group pages. Interviewers will also use convenience sampling in administering the health workers’ questionnaire (via KoBoCollect installed in android devices) to those who do not have online contact and those living in remote areas with poor internet connectivity. About five to six eligible health workers, both those who have received and those who have not receive COVID-19 vaccination, will be selected purposively for FGDs. Data will be analysed using Stata/SE V.15.1 (Stata Corp, College Station, Texas). Analyses of the community members data will be based on population-averaged models that account for clustering. Point estimates of the outcome measures will be computed for each comparison group as defined in the study hypotheses. Each hypothesis with dichotomous or categorical independent factor will be tested by computing prevalence difference (with 97.5% CI and p values) in binary outcome measure using binomial identity, and mean difference (with 97.5% CI and p values) in continuous outcome measure using Gaussian identity, generalised estimating equations (GEE) with an exchangeable correlation matrix and robust standard errors. Each hypothesis with continuous independent factor will be tested by computing coefficient (with 97.5% CI and p values) in binary and continuous outcome measures, respectively, using the binomial identity and Gaussian identity GEE models. For each independent factor (in a hypothesis) being tested, adjusted analysis will be done by inputting into the GEE model the other independent factors as appropriate. For clarity, the potential independent factors to control for are presented in table 3. Both unadjusted and adjusted results will be reported. If the binomial identity GEE model fails to run or convergence is not achieved, Gaussian identity GEE model or generalised least square random-effects linear regression model (with robust standard errors) or maximum likelihood random-effects linear regression model will be used instead.87 Independent factors to input into multivariate models in adjusted analyses *Among only community members. †Among only health workers. ‡Fear of getting COVID-19, possible to get (severe) COVID-19, ever had COVID-19, and knowledge of any person who have had COVID-19. §Importance of COVID-19 vaccination, fear of having severe side-effects from COVID-19 vaccination, protection from receiving COVID-19 vaccination, trust for the health workers who give COVID-19 vaccination, trust for the government who made COVID-19 vaccination available. ¶Ever heard COVID-19 vaccination was available for receipt and knowledge of a COVID-19 vaccination place. The same analytic technique will be used for the analyses of the health workers’ data except that generalised linear model with robust SEs will be used in place of GEE model because of the absence of cluster design in the health worker survey. Summary statistics will be used to assess COVID-19 vaccination acceptance (the intention to receive, timeliness of the intention to receive, uptake and hesitancy); 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 among community members and health workers. The qualitative data (FGD transcripts) will be analysed thematically based on predetermined themes in the study’s conceptual framework. The qualitative data will be analysed, interpreted and presented independently of the quantitative data. Ethical approval for this study was obtained from the Ebonyi State Health Research and Ethics Committee (EBSHREC/15/01/2022–02/01/2023) and Research and Ethics Committee of Alex Ekwueme Federal University Teaching Hospital Abakaliki (14/12/2021–17/02/2022). The investigators will obtain verbal consent/permission from the heads of the selected clusters. During the household survey, the interviewers will obtain verbal consent from the household members aged 18 years and above and assent from household members aged less than 18 years (after obtaining consent from the heads of households). The health workers will be informed that only those that give consent should take the online survey. The moderators of the FGDs will obtain verbal consent from the respondents before each FGD. The purpose the study, the kind of participation, likely duration of participation, voluntary nature of participation, absence of potential harm, potential benefit and confidential nature of the study will be communicated to participants as required. The online record of the anonymised quantitative data will be passworded and the audio recordings and the electronic verbatim transcript of the FGDs will be stored in a passworded computer to prevent unauthorised access. Study findings will be reported at local, national and international levels in high impact peer-reviewed journals and conferences as appropriate. Patients or the public were not involved in the design and reporting or dissemination plans and will not be involved in the conduct of our research.
