Knowledge, attitudes, and perceptions (KAP) of maternal respiratory syncytial virus (RSV) vaccines among healthcare workers in Cape Town, South Africa: a mixed-method study protocol

¹Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa, ²Vaccines for Africa Initiative, School of Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa, ³Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, University of Cape Town, Cape Town, South Africa, ⁴National Immunization Technical Advisory Group (NITAG) Support Hub (NISH), School of Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

^&Corresponding author
Lubayna Khan, Division of Epidemiology and Biostatistics, School of Public Health, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

Study protocol  

Introduction

Respiratory Syncytial Virus (RSV) is a significant cause of acute lower respiratory infections (ALRIs) in infants and young children, with the highest burden of severe disease occurring within the first six months of life [1]. Globally, RSV accounts for over 33 million ALRI cases annually, resulting in approximately 3.2 million hospitalizations and nearly 59,600 in-hospital deaths among children under five [2]. Young children and infants are disproportionately affected by RSV due to several immunological and physiological factors [1-5].

Infants primarily rely on passive immunity at birth that is transplacentally acquired via maternal immunoglobulin G (IgG), which only provides short-term protection [3,4]. These maternal antibodies wane within the first few months of life thereby leaving infants vulnerable to viral infections including RSV [3]. Additionally, infants have an underdeveloped adaptive immune system that exhibits a Th2-predominant response, resulting in suboptimal viral clearance and increased inflammation predisposing them to a higher risk of severe lower respiratory tract infections [4]. Preterm birth is an additional risk factor that exacerbates RSV vulnerability [6]. Premature infants are susceptible to severe RSV infections due to their underdeveloped lung morphology and a lack of passive maternal antibody transfer in the final trimester of pregnancy [6]. The structural development of the small airways is incomplete in preterm infants, leading to increased airway resistance, poor secretion clearance and increased susceptibility to bronchiolitis when infected with RSV [6]. Furthermore, reduced pulmonary compliance and impaired surfactant function contribute to air trapping, wheezing and respiratory distress which are notable features of RSV infection in preterm infants [6,7]. Given these immunological and anatomical vulnerabilities, RSV remains a leading cause of hospitalization in young children, reinforcing the need for early preventative strategies [6,8].

In low- and middle-income countries (LMICs) the public health impact of RSV is especially pronounced due to inadequate healthcare infrastructure and underlying high-risk factors such as co-morbidities including Human Immunodeficiency Virus (HIV) co-infections, and poor socio-economic conditions including overcrowding [6,9]. A South African study has shown that HIV-exposed but uninfected infants face a significantly higher risk of RSV-related illness and hospitalization, underscoring the heightened vulnerability of this group and the need for targeted prevention strategies [9]. Overcrowded living environments facilitate rapid RSV transmission within households and communities, especially in settings where families share confined living spaces thereby increasing transmission [6,9]. Low levels of awareness about RSV among caregivers and healthcare providers contribute to delayed recognition of symptoms that often result in late presentation to healthcare facilities and an increased risk of severe complications [1,6]. In contrast, high-income countries benefit from early diagnosis, surveillance, and access to monoclonal antibody prophylaxis (e.g., Palivizumab), measures often unavailable in LMICs due to unaffordable associated costs [6,10,11]. These disparities highlight the need for a more cost-effective prevention modality to curb the spread and occurrence of RSV infections in LMICs and bridge existing healthcare gaps [12].

A recent systematic review found that 23.52% of ALRIs in sub-Saharan Africa were RSV-positive, with 85.8% of that burden directly attributed to RSV, underlining its role as a major cause of infant morbidity and mortality [13]. Data from South Africa indicate that infants under two months carry the greatest burden of RSV-related hospitalizations, highlighting the urgent need for effective preventive strategies [14,15]. There is currently no licensed pediatric RSV vaccine and attempts to develop a neonatal RSV vaccine have been unsuccessful due to the immaturity of the neonatal immune system, which limits the ability to generate long-lasting immunity [16]. Maternal immunization has consequently emerged as a feasible alternative, with the newly approved RSVpreF (Abrysvo) vaccine demonstrating efficacy in reducing infant hospitalizations when administered during pregnancy [15,17,18]. While endorsed in countries such as the United States [19], the vaccine is not yet rolled out in the South African public healthcare system [15].

Healthcare workers (HCWs) are essential stakeholders in maternal immunization programs, as their knowledge, attitudes, and perceptions (KAP) influence vaccine acceptance among pregnant women [20-23]. Although global evidence shows HCWs generally support maternal vaccination, knowledge gaps and misconceptions around vaccine safety may negatively influence recommendation practices [23]. Currently, we have no understanding of HCWs' views toward maternal RSV vaccination in the South African context despite imminent implementation of the program. This critical gap in local data highlights the need for targeted research to guide future implementation efforts in South Africa.

Aims and objectives: this study aims to evaluate the baseline knowledge, attitudes, and perceptions (KAP) of healthcare workers (HCWs) in Cape Town, South Africa, toward maternal RSV vaccines. It also seeks to identify HCWs' perspectives on potential barriers and facilitators to maternal RSV vaccine acceptance and uptake among pregnant women.

Methods

Study design: this study will employ a mixed-methods cross-sectional design to assess the KAP of HCWs in Cape Town, South Africa regarding maternal RSV vaccination. A mixed-methods approach is well-suited for this study as it allows for a comprehensive understanding of the subject matter by combining both quantitative and qualitative data. The quantitative aspect will enable us to determine proportions and identify associations within the study population, specifically regarding HCWs' knowledge scores, attitudes, and perceptions toward the maternal RSV vaccine. This will provide measurable insights aligned with the primary aim of establishing a baseline understanding of KAP related RSV and maternal RSV vaccination. The qualitative aspect will offer context-rich insights that enhance our interpretation of the quantitative findings while further exploring HCWs' perceptions of potential barriers and facilitators to maternal RSV vaccine acceptance among pregnant women. As part of a broader research initiative, this sub-study is nested within a larger project led by the Vaccines for Africa Initiative (VACFA), which seeks to deepen our understanding of maternal vaccine decision-making in Cape Town, South Africa [24]. Expanding on the parent study, this sub-study specifically explores HCWs perspectives on maternal RSV vaccination, addressing a critical gap in the existing knowledge base.

Study setting and population: this study will be conducted in the City of Cape Town Metropolitan Municipality within the Western Cape province. This municipality has a range of maternal and neonatal healthcare facilities that provide specialized care for pregnant women and newborns. These facilities include primary healthcare clinics such as midwife obstetric units (MOUs), which serve as the first point of contact for maternal care and refer high-risk pregnancies to secondary and tertiary-level hospitals within the Cape Metropolitan vicinity for specialized management and advanced neonatal care. For this sub-study, facilities will be selected to represent primary, secondary and/or tertiary levels of care. This selection ensures diversity in healthcare levels, patient catchment areas, and service provision. Our target population are HCWs who are employed in maternal and child health divisions at the respective facilities. For this study, HCWs will include doctors, midwives, nurses, pharmacists, breastfeeding specialists, and counsellors.

Eligibility criteria: healthcare workers who are currently employed at the selected facilities and provide direct maternal, neonatal, or pediatric care will be eligible to participate. This includes individuals across all levels of clinical experience, provided they are actively engaged in maternal or child health services and are willing to provide informed consent. Healthcare workers who do not work in maternal or child health departments, as well as administrative and non-clinical staff, will be excluded.

Sample size estimation: based on an estimated HCW population of 350, the minimum required sample size was calculated using Statulator [25] with a 95% confidence level, 5% margin of error, and 80% power. A pilot sample of five and a 10% contingency for dropouts were added, resulting in a target sample of 230. Facilities will be purposively selected, and all eligible HCWs in participating facilities will be approached to complete a questionnaire survey. A subset of approximately 9 HCWs will be recruited to participate in semi-structured interviews as part of the qualitative component of this study. The selection of participants to be interviewed will be informed by initial quantitative findings, thereby ensuring representation across key HCW cadres while allowing flexibility to focus on groups most relevant to emerging themes.

Recruitment strategy: participants will be recruited throughout the working day with efforts made to engage them during staff briefings and shift handovers to maximize participation while minimizing disruption to clinical duties. Operational managers and departmental leads will be consulted to facilitate the recruitment process. While no financial incentives will be provided, participants will receive a thank-you pack containing stationery and refreshments to compensate for their time. The recruitment strategy will be reviewed biweekly, and adjustments will be made as needed to ensure timely enrolment and achievement of the target sample size.

Data collection

Quantitative survey: the quantitative component of this study will be conducted using a structured KAP survey, administered via REDCap [26,27] on mobile tablet devices. This survey has been developed based on an extensive review of the extant literature on RSV and informed by previously published KAP surveys [6,14-17,22,28-29] on maternal RSV vaccination among HCWs (see survey template in Annex 1). The survey includes four sections: demographics and employment history; RSV knowledge; attitudes toward vaccine safety and effectiveness; and perceptions of barriers to uptake. Responses will be self-administered in English (the official medium of communication in the professional setting in South Africa) using multiple-choice questions. Researchers will facilitate survey completion to ensure eligibility and confidentiality. This approach ensures that only eligible participants complete the survey, supports data quality, and maintains participant confidentiality. Knowledge scores will be calculated based on the number of correct responses, while attitude and perception scores will be analyzed using summative Likert scale responses where appropriate.

Qualitative interviews: semi-structured one-on-one interviews will be conducted with a subset (n=~9) of HCWs. These interviews will further explore perceived barriers, facilitators, and attitudes toward maternal RSV vaccination to complement survey findings. Interviews will be scheduled at participants' convenience and will be conducted in private staff areas to respect confidentiality and limit distraction. Virtual interviews will be available for those unable to attend in person due to work or other commitments. A semi-structured interview guide will be developed based on the WHO Behavioural and Social Drivers (BeSD) of Vaccination framework [30], adapted to incorporate insights from RSV literature [22-24,29,30], preliminary quantitative findings, and expert input (see interview guide template in Annex 1). Interviews will explore HCWs' perceptions of maternal RSV vaccination, anticipated barriers to vaccine uptake among pregnant women, and their role in vaccine advocacy and implementation. The guide will cover HCWs' awareness, anticipated challenges, enabling factors, and their role in future implementation. Open-ended responses will be encouraged. Interviews will be conducted in English, audio-recorded with consent, transcribed verbatim, and analyzed using Braun and Clarke's framework [31]. Field notes will be taken to capture contextual insights.

Data management: survey responses will be automatically recorded and stored in REDCap [26,27], ensuring real-time data capture, encrypted cloud storage, and automatic backups. Only authorized members of the research team will have password-protected access to maintain data security. Signed informed consent forms will be securely stored in locked cabinets at the VACFA office. Audio recordings from qualitative interviews will be stored in encrypted, password-protected files on a secure institutional server. In line with national data protection regulations, audio files will be retained for six months post-transcription before being permanently deleted. Transcripts will be de-identified to protect participant anonymity. All data handling will comply with South Africa's Protection of Personal Information (POPI) Act [32]. At the publication stage, de-identified datasets may be deposited in an open-access research repository (e.g., UCT's data repository or a journal-specific platform) in compliance with open data-sharing policies.

Quality control and assurance: the survey questionnaire was pre-tested among a group of professionals from VACFA and the School of Public Health at the University of Cape Town to assess clarity, structure, face validity, and average completion time. Based on this preliminary feedback, minor revisions were made to improve question flow and wording, and these changes are reflected in the final version of the survey included in the appendix. The semi-structured interview guide will also undergo pre-testing prior to qualitative data collection. To maintain data quality, the research team will meet routinely throughout the study period to review any challenges in data collection and validation, and implement adaptations as appropriate. For the survey, data integrity will be maintained through automated validation checks in REDCap [26,27], and triangulation will be applied by comparing responses across different HCW cadres. To ensure credibility and reliability, data collection and analysis will involve peer debriefing and member checking, tailored to the study's mixed-methods approach.

Data analysis: survey responses will be analyzed using the latest version of RStudio (version: 2024.12.1+563), while the data transcribed from the semi-structured interviews will be analyzed using NVivo 15 software.

Quantitative data analysis: survey responses will be exported from REDCap and analyzed using RStudio. Descriptive statistics will be applied, with frequencies, proportions, and percentages used to summarize categorical variables (e.g., profession, prior RSV training), while means and standard deviations (SD) will summarize continuous variables (e.g., age, years of experience, knowledge scores/summative scores). Inferential statistics will include Chi-square tests to assess associations between categorical variables (e.g., prior RSV training and willingness to recommend the vaccine), and independent t-tests or Mann-Whitney U tests to compare continuous variables between groups. Modified Poisson regression will be used to estimate relative risks while adjusting for potential confounders. Findings will be reported using tables and graphs for ease of interpretation, and results will be stratified where necessary to explore variations by profession or facility type.

Qualitative data analysis: interview transcripts will be analyzed using thematic analysis in NVivo 15 to identify patterns in HCWs' perspectives on maternal RSV vaccination. The analysis will follow Braun and Clarke's six-step framework [31] illustrated in Figure 1 and listed below: 1. Familiarization: Transcripts will be read multiple times for initial impressions; 2. Initial Coding: Key phrases and ideas will be coded inductively and deductively; 3. Theme Identification: Codes will be grouped into overarching themes related to study objectives; 4. Theme review: Themes will be refined and validated against the dataset; 5. Definition & Naming: Themes will be clearly defined, ensuring alignment with research questions; 6. Reporting: Direct quotes from participants will illustrate key findings and enhance depth of interpretation.

The primary researcher (LK) will perform the initial coding of transcribed data. A second coder (IA) will review a subset for inter-coder reliability. Discrepancies will be discussed until consensus is reached. Integration of Quantitative and Qualitative Findings: Since this is a mixed-methods study, findings from both components will be integrated using a triangulation approach. Quantitative survey results will provide broad trends in HCWs' knowledge and attitudes, while qualitative insights will add context and depth to these findings. Thematic patterns from qualitative analysis will be compared against survey trends to identify areas of agreement and divergence. Where necessary, qualitative findings will explain unexpected quantitative results, ensuring a holistic understanding of HCWs' perspectives on maternal RSV vaccination. This integrated approach will ensure that the study captures both statistical associations and the lived experiences that influence vaccine-related decision-making.

Anticipated findings: we anticipate that the findings of this study will provide baseline evidence on HCWs' KAP regarding maternal RSV vaccination in South Africa. Given that HCWs play a pivotal role in vaccine acceptance and recommendation, understanding their perspectives will inform targeted training, context-specific policy development, and effective communication strategies for the eventual rollout of maternal RSV vaccines in South Africa and similar contexts. These findings are expected to inform South Africa's National Immunization Technical Advisory Group (NITAG) and other policymakers on potential barriers and facilitators to implementation, while also highlighting gaps in HCW knowledge and attitudes that may require tailored educational interventions. Additionally, this study will lay the groundwork for future longitudinal research to assess HCW engagement and its impact on RSV vaccine uptake trends post-implementation. By advancing the understanding of HCW readiness for maternal RSV vaccination, this study aligns with and contributes to the legacy of 50 years of immunization programmes in Africa by supporting the next phase of life-course immunization strategies to improve maternal and child health outcomes across the continent.

Ethical considerations: ethics approval for the overarching study [Ref: 011/2023] and the current sub-study [Ref: 293/2025] was granted by the University of Cape Town Faculty of Health Sciences Human Research Ethics Committee. As part of the broader study, permission was obtained from the Western Cape Department of Health to access multiple maternal health facilities. The primary researcher will provide verbal and written information about the study to potential participants. Written informed consent will be obtained from all participants prior to data collection. Participation will be voluntary, with the right to withdraw at any time without consequence. The study will adhere to ethical guidelines and ensure compliance with POPIA.

Limitations: as a cross-sectional study, findings will reflect HCWs' perspectives at a single point in time and may not capture changes over time. The use of purposive sampling, while common in KAP studies, may limit generalizability. Self-reported data introduces the risk of response and social desirability bias, particularly in interviews where participants may provide professionally favourable responses. Despite these limitations, the study offers timely insights to support planning for maternal RSV vaccine implementation in South Africa.

Competing interests     

The authors declare no competing interests.

Authors' contributions     

All authors contributed to the conceptualization of the manuscript and have also read and agreed to the final manuscript.

Figure     

Figure 1: adaptation of the Braun and Clarke six-step framework for thematic analysis

Annex     

Annex 1: supplentary material, 800KB

References