key: cord-0849914-0zypiluw
authors: Wiysonge, C. S.; Coulson, N.; Pillay, N.; Cooper, S.; Groenewald, C.; Essack, Z.; Parker, S.; Houston, G.; Simmonds, J.; Jaca, A.; Mutemwa, M.; Katoto, P. D.; Rooyen, H. v.
title: Community-based Case Studies of Vaccine Hesitancy and the COVID-19 Response in South Africa; The VaxScenes Study
date: 2022-02-22
journal: nan
DOI: 10.1101/2022.02.21.22271272
sha: a914d454eab1b1bc6dd83d1dbebe084e73ab21a7
doc_id: 849914
cord_uid: 0zypiluw

Background South Africa has reported more than half of all COVID-19 cases and deaths in Africa. The South African government has launched a large COVID-19 immunization campaign with the goal of reaching more than 40 million individuals. Nonetheless, certain international, largely internet-based surveys have shown a significant proportion of vaccine hesitancy in South Africa. This study aims to determine and co-create with local stakeholders a comprehensive understanding of vaccine hesitancy and opportunities to support the promotion of other COVID-19 health-promoting behaviours at community level. Methods and design A mixed-methods, multiple case-study design; informed by the socio-ecological model of behaviour change. Four socio-economically diverse communities across South Africa will be selected and data collection will take place concurrently through three iterative phases. Phase 1 will provide insights into community experiences of COVID-19 (response) through desktop mapping exercises, observations, in-depth interviews, and focus group discussions (FGDs) designed as expression sessions with local stakeholders. Phase 2 will explore the extent and drivers of community acceptance of COVID-19 vaccines. This phase will comprise a quantitative survey based on WHOs Behavioural and Social Drivers of Vaccination tool as well as further FGDs with community members. Phase 3 will involve cross-case study syntheses and presentation of findings to national role-players. Discussion This study will provide ground up, locally responsive, and timeous evidence on the factors influencing COVID-19 health-seeking behaviours to inform ongoing management and mitigation of COVID-19 in South Africa. It will also provide insights into the applicability of a novel vaccine hesitancy model in Africa.

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The copyright holder for this this version posted February 22, 2022. ;  https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint 87 reduce and prevent the spread of COVID-19 in the country [1, 2] . At the same time, the safety 88 and efficacy of a number of COVID-19 vaccines had been established and the manufacture, 89 procurement, and rollout of these vaccines was a global priority [7] . Contrary to high-income 90 countries, at the beginning of 2021, limited numbers of vaccine doses had been procured for 91 South Africa and ongoing procurement and rollout was uncertain [8] . However, vaccinating 92 the South African population at scale with efficiency was a top government priority. COVID- 93 19 vaccine uptake will involve behaviour change at a large scale as the government aims for a 94 vaccination coverage of at least 67% of the South African population in order to control 95 COVID-19 infections in the country [9] .

Vaccine hesitancy is one of the main challenges to be addressed for the vaccine programme to 98 work in South Africa [10] . Vaccine hesitancy, according to WHO's global working group on 99 "Measuring Behavioural and Social Drivers of Vaccination" (BeSD) is a "motivational state of 100 being conflicted about, or opposed to, getting vaccinated" which includes intentions [11] . 101 Limited evidence available in early 2021 showed wide variation in COVID-19 vaccine 102 hesitancy from 18% to 48% across various time points and geographical locations in South 103 Africa [12, 13] . Many elements could have contributed to the vaccine hesitancy. For example, 104 previous experiences that communities have of the delivery of healthcare services could 105 influence both vaccine intentions and uptake [14] . Contextual factors that shape the enabling 106 environment for vaccine uptake within a middle-income country like South Africa might be 107 expected to play a bigger role in levels of vaccine hesitancy when compared with the results 108 found in other studies which are largely conducted in high-income countries [15, 16] . For 109 example, the availability and cost of transport is regularly a barrier to access to healthcare 110 services in resource constrained communities [17, 18] . In addition, the dominance of social 111 media has been shown in a global study to directly impact on vaccine uptake [19] . Even before . CC-BY 4.0 International license It is made available under a perpetuity.

is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint chambers of fake information about vaccination on social media and the internet [20] [21] [22] [23] [24] [25] [26] .

Ensuring optimal uptake of COVID-19 vaccines in South Africa would thus involve multiple 116 factors including knowledge, creating an enabling environment, addressing social influences, 117 and personal motivation [18, 27, 28] . The preceding sections highlight the need for a ground 118 up, contextually informed approach, that recognises the lived experience and understanding of 119 individuals and places them in the social world in which they live and work. That was the 120 rationale for the proposed VaxScenes Study, which aims to determine and co-create with local 

The specific objectives are to: is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Four community-based case studies will be undertaken using the socio-ecological model 142 [29] . The research methods to be applied in the case studies are described in further detail in 143 the following sections. Each component of data collection will be complemented by a process 144 of engagement with stakeholders at the community level, described as action research [30] .

These stakeholders will be identified during community-level mapping, and will include local 146 community leadership and service providers, such as health facility managers and school 147 principals. These and other key informants will be interviewed and then invited to participate 148 in workshops to contribute to the interpretation of findings and to co-create community-level 149 strategies to address vaccine hesitancy and to strengthen the COVID- 19 is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint levels. Information about the COVID-19 vaccine in isolation to other interventions will not be 160 sufficient to get the uptake required for herd immunity; information and strategies that address 161 vaccine hesitancy and that motivate people to access COVID-19 vaccines are also needed. It is 162 critical to behaviour change in a community that all four of the levels -personal, interpersonal, 163 community, and social/political -be capacitated for a change in behaviour to occur in many 164 people and then be maintained and sustained. Box 1 illustrates how the different levels of the 165 socio-ecological model can be applied to address vaccine hesitancy. In practice, we will 166 contextualise tools recently developed by the BeSD working group and use them in this study.

The BeSD framework consists of four domains that could potentially shape vaccine intentions 168 and uptake, namely, what people think and feel about vaccines; social processes that drive or 169 inhibit vaccination; individual motivations (or hesitancy) to seek vaccination; and practical 170 factors that shape the experience of seeking and receiving vaccination [14] .

The BeSD tools include qualitative tools (in form of guides for in-depth interviews with 173 stakeholders), quantitative tools (that is, questionnaires for population surveys), and a 174 guidebook to support implementation of the tools. The tools focus on childhood vaccination Box 1: Applying the socio-ecological model to address vaccine hesitancy Individual (Self): understand the information about the vaccine (know that it is available and it is recommended that you get it), be motivated to get it, and be able to get access Interpersonal: getting the vaccine needs support from partners, family members, and peers, or at least encouragement for this behaviour Community: getting the vaccine needs to become a social norm and the socially accepted and expected thing to do.

You need to be able to access the vaccine easily and safely at a local primary healthcare facility, doctor or workplace.

Religious organisations, community organisations, local leaders, traditional leaders, traditional healers, and other influencers (social and political) need to be supportive of vaccine uptake Environment: At a public policy level, the availability of the vaccine needs to be secured and the vaccine needs to be available. Resources need to be available to place vaccination centres within easy reach of the community. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint and COVID-19 vaccination for health workers and for adults [14] . We will adapt the BeSD 176 COVID-19 vaccination tools for adults to our local context [31] . 

This research is designed as multiple case studies of four sites. Case study research is empirical 183 research that explores a contemporary phenomenon within its real-world context [32] . Case 184 studies are especially useful when the boundaries and interface between the "phenomenon" (or 185 "the case") and the "context" are not so clear. Case studies usually rely on multiple sources of 186 data. In our study, the "phenomenon" is the introduction of COVID-19 vaccination into the four adopting an approach that relies on more than one data collection method, it is possible through 190 a case study to describe, explore, and explain the "how and why" of possible vaccine hesitancy 191 without presuming at the outset to know the contextual and other factors that are shaping local 192 behaviour. The research methods will be carefully replicated at each site; the underlying goal 193 being either that the research will provide the replication of results across sites or that the case 194 studies will provide theory that can predict either similar or contrasting findings across different 195 communities [32] . In either case, multiple case studies will provide evidence that will be 196 helpful to the activities of the South African Government in addressing vaccine hesitancy. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint Table 1 shows the site selection of the four case studies. Convenience and purposive sampling 199 were used in the selection of sites. Convenience sampling ensured that some sites which are 200 well known to the study team with established research and community networks to facilitate 201 speedy data collection can be used. Purposive sampling will allow the team to include a mix of 202 sites from different South African provinces badly affected by COVID-19 and to include 203 communities that reflect formal and informal urban contexts as well as peri-urban and rural 204 environments. Study sites were selected in KwaZulu Natal, Gauteng, and Western Cape 205 provinces, which were the three provinces with highest numbers of COVID-19 cases in South 206 Africa in early 2021 [33] . In KwaZulu Natal Province we selected an urban community 207 (Wentworth) and a semi-rural one (Sweetwaters). In Gauteng Province we selected an urban 208 informal community known as Alexandra. Finally, in the Western Cape Province, an urban 209 middle-class community was selected. The selected sites have markedly different populations 210 as shown in Table 1 . is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The source of the provincial COVID-19 data is the South African National 214 Department of Health, as reported on 29 January 2021 [33] . 215 

At each case study site, teams will use a mixed methods approach to data collection with 217 quantitative and qualitative elements to address all research objectives. Figure 1 illustrates the 218 overall approach to the study that is to be replicated in each of the case study sites. At each 219 site data collection and the dissemination of findings will be organised into three distinctive 220 phases. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint In Phase 2, the case study research design will throw a spotlight on community acceptance of 239 COVID-19 vaccines. A quantitative survey and further FGDs will be conducted with groups in 240 the community. The findings of the survey and focus group discussions will be shared with the 241 key informants at a second workshop and this will form the basis for stakeholders co-creating 242 strategies to maximise vaccine acceptance within their ward. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Table 2 summarises the study population for both the qualitative and quantitative components. 255 The study will only recruit people who are aged 18 years or older. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Participants for both types of FGDs will be purposively identified. Three FGDs of each type 274 will be held at each site. During Phase 1 no more than six participants will be recruited into the 275 expression sessions. The sessions will be implemented in a group setting consisting of no more 276 than six participants. The small sample size here is deliberate, to allow for meaningful 277 engagement in the focus group discussions. Participants who have been badly affected by 278 COVID-19 either through sickness, death, or economic loss will be recruited into the 279 expression sessions. A social worker will be available at each site to ensure that any trauma 280 experienced during or after the sessions can be appropriately referred. In Phase 2, between six 281 and eight participants will be purposively recruited into the FGDs that are to be supported with is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Three discrete but interlinking components of data collection will be undertaken for each is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The mapping exercise will identify key stakeholders in each community to be approached 324 for interview. Researchers will use a semi-structured interview guide (see Appendix A1), 325 adapted from the BeSD qualitative tools for COVID-19 vaccination, for KIIs. The latter will 326 be conducted face-to-face at the community level or over virtual platforms; depending on 327 COVID-19 conditions at the time, participant preferences, and other practical considerations.

The KIIs will explore a range of themes including: participants' personal, family and community Two types of FGDs will be conducted. The first type will apply an approach called 343 "expression sessions" [35] . The second type of FDG will rely on a semi-structured FGD guides. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint and a well-ventilated venue. FGDs will be capped at six participants for expression sessions and 348 eight for other FGDs. The tools will be piloted in one community and amendments made 349 thereafter. All FGDs will be audio recorded with the permission of participants. Thereafter 350 recordings will be translated as necessary and transcribed. sharing 'something' rather than photos only. 'Something' could be images, photos, videos 361 (self-taken, downloaded online, or from a book or magazine), a song (audio or lyrics), a drawing 362 (self-drawn or a picture of a drawing), or a poem (self-written or not). Participants will be 363 encouraged to bring their 'somethings' to a FGD. Participants will receive a brief formative 364 training session on the methodology along with a set of two research probes to which they can 365 respond by bringing 'something' (see Appendix A2). Following the formative session, 366 participants will have one week to gather their 'somethings'. Expression session FGDs will be 367 facilitated by two researchers and will be conducted in the dominant or preferred language of 368 the group. Each team will include a researcher with local language capacity. Participant 369 information sheets and consent forms will be translated into the local language. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint Conventional FGDs will be conducted with three stakeholder groups who are able to 372 address vaccine hesitancy in the community and provide support to the local response to 373 improve acceptance and uptake of vaccines. These FDGs will focus on how to strengthen the 374 community response to vaccine hesitancy and to promote on-going COVID health seeking 375 behaviours. A semi-structured FGD protocol is found in Appendix A3. FGDs will be facilitated 376 by two researchers. It is anticipated that most of these FGDs can be conducted in English but 377 researchers with local language capacity will be included in each research team. Participant 378 information sheets and consent forms will be translated into the local language. vaccination; and practical factors that shape the experience of seeking and receiving COVID-385 19 vaccination [14] . The BeSD quantitative tool adapted for this study is provided in Appendix 386 A4. The survey will be conducted in English, Afrikaans, and isiZulu since these are 387 predominant languages spoken in the selected communities. Participant information sheets and 388 consent forms will also be translated into the local language. The survey tool will be piloted 389 among 100 adults in one of the first community sites. Where needed additions will be made to 390 the survey to assist with the translation of specific terms. Data will be captured onto tablets 391 during face-to-face interviews conducted by well-trained researchers working in each 392 community site. The researchers will wear masks, practice physical distancing when 393 approaching potential participants, use hand sanitisers regularly, and adhere to all other 394 COVID-19 protocols. Should the period for interviews in any given community coincide with 395 the period of lockdown, face-to-face interviews will be replaced with online questionnaires. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint The research team will adopt an approach to data collection that is compliant with all the 398 rules pertaining to the COVID-19 response. It is expected that some qualitative data collection 399 will be virtual and meetings to discuss findings with local stakeholders may be virtual where 400 appropriate. Onsite researchers will use personal protective equipment (including face masks 401 and hand sanitisers) and with provide PPE to FGD participants. Meetings and FGDs will be 402 made in well ventilated venues and seating will be appropriately physically distanced. Iterative analyses of all data will occur at each community site as the research team moves 405 from Phase 1 to Phase 3. Data will be triangulated across methods to promote validity. Case-406 specific and cross-case syntheses will be undertaken as appropriate and as determined by the 407 findings. Qualitative data will be audio recorded, transcribed, and translated where required.

Transcripts will be organised and stored using qualitative data software such as MaxQDA and 411 ATLAS.ti (version 9) to facilitate coding and analyses of data. Qualitative data will be subject 412 to thematic analysis [38] . A code book will be developed for the data including both inductive 413 and deductive codes [39] , but emphasis will be placed on allowing the data to determine codes 414 [40] . The codes will be discussed between the four qualitative researchers involved in the case 415 studies and with the four study principal investigators. An inter-coder agreement will be 416 established with a portion of the data to verify and enhance data credibility. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint and R/Rstudio v3 softwares will be used for data analyses. The survey data will be summarised 421 as counts and percentages for categorical variables and means with their standard deviations for 422 continuous variables. Analysis of the variance (ANOVA), chi-square tests, and equivalents will 423 be used as appropriate for group comparisons. Logistic regression models will also be used to 424 evaluate the association between selected characteristics and vaccine hesitancy as well as 425 adherence to NPIs. A basic model will be adjusted for age and sex. Expanded multivariable 426 models for the outcome "vaccine hesitancy" will be further adjusted for significant predictors 427 in basic models. Additional data analyses will include subgroup analyses conducted using 428 variables such as race, sex, socio-economic status, geographical location, education levels, and 429 occupation to match areas specific needs. A P-value less than 0.05 will be used to indicate 430 statistically significant results. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint Personal identifiers during KIIs and FGDs will not be used in the reporting and all data 445 will be reported in a summarised form (sex, age) without attributing comments or information 446 to individuals. FGD participants will be informed that while all steps will be taken towards 447 maintaining confidentiality and anonymity, this cannot be guaranteed due to the nature of 448 sharing encouraged by FGDs. While FGD participants will know each other's identity and the 449 information shared, an environment of private sharing will be encouraged; highlighting the 450 importance of maintaining confidentiality for all participants. Furthermore, a local social 451 worker will be available at each site to support or refer any participant that experiences any 452 psychosocial concerns during or after the expression session FGDs. All data will only be used 453 for research purposes and kept with utmost confidentiality, and they will not be accessed by 454 anyone else but the research team.

Respondents will be reimbursed for their participation in the study. This is ethically sound 456 and is aligned to the "time, inconvenience, and expenses" (TIE) model [41] and is endorsed by 457 the National Health Research Ethics Council of South Africa [42] . The reimbursement amounts 458 proposed for the study are aligned to TIE that reimburses participants for their time at a rate on 459 par with unskilled labour rates, for their inconvenience and for any expenses (e.g., transport, is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 

Previous studies have shown high levels of vaccine hesitancy in South Africa [9, 13, 43] . 471 These high levels of are most likely to be driven by multiple factors including personal, 472 interpersonal, community, and social. We therefore propose in this study to determine and co- is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint

The copyright holder for this this version posted February 22, 2022. ; https://doi.org/10.1101/2022.02.21.22271272 doi: medRxiv preprint and how this determines effective health promotion strategies. One of the most effective 495 applications of the socio-ecological model is at the community level. This is because the 496 enablers or barriers to behaviour change in the four levels (i.e., personal, interpersonal, 497 community, social) of the model can be readily identified. For example, if a local faith leader is 498 speaking out against vaccination, it will most likely have an impact on the social norms of the 499 local community. Similarly, if the local clinic has a reputation for providing poor services, then 500 this too will affect vaccine uptake because it is a barrier to establishing an enabling environment. This mixed methods study is designed as an action research study that is responsive to the 506 local context and is conducted to influence the ongoing management and mitigation of COVID-507 19 in South Africa. To address the issue of COVID-19 vaccine uptake, an integrated analysis 508 is necessary to provide community stakeholders with a comprehensive understanding of the 509 factors that will assist the identification of helpful health promotion activities at the local level 510 to support COVID-19 vaccine rollout. Convenience sampling is best suited for this type of 511 study, although this would limit the generalisability of the findings to all communities in South 512 Africa. However, we believe that the study will make a substantial contribution to knowledge 513 on COVID-19 response in South Africa, as the case study research will be conducted in four 514 commonplace settings in the country. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint However, their success depends on high levels of uptake and adherence. The aim of this study 520 is to determine and co-create with local stakeholders a comprehensive understanding of vaccine 521 hesitancy and opportunities to support the promotion of other COVID-19 health-promoting 522 behaviours. The study will utilise a mixed-methods, multiple case study design, informed by 523 the socio-ecological model of behaviour change. The study will provide ground-up, locally 524 responsive, and timeous evidence on the factors influencing COVID-19 vaccine acceptance 525 and other health-seeking behaviours to inform the management and mitigation of the pandemic 526 in South Africa. It will also provide insights into the applicability of various global vaccine 527 hesitancy models and research tools to a middle-income country in Africa. is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint 

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is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint is the author/funder, who has granted medRxiv a license to display the preprint in (which was not certified by peer review) preprint