Gaps in the implementation of RTS, S malaria vaccine contributing to the low uptake in an endemic area of western Kenya

doi:10.21203/rs.3.rs-4669797/v1

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Case Report

Gaps in the implementation of RTS, S malaria vaccine contributing to the low uptake in an endemic area of western Kenya

https://doi.org/10.21203/rs.3.rs-4669797/v1

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Background:

Globally in 2021, there were an estimated 247 million malaria cases in 85 malaria-endemic countries which accounted for over 619,000 deaths worldwide. In every 1000 live births, 84 die before attaining 5 years in Kenya. Nonetheless, presently, there is a malaria vaccine which an affordable intervention for children under 5 years of age. However, there is low uptake of 3^rd and 4^th doses with very limited information on the gaps in the implementation of this vaccine to inform strategies to improve the uptake.

Materials and Methods:

Study design:

The study employed an exploratory study design. Purposive sampling method was used to select participants for focus group discussions (FGDs) and key informant interviews (KIIs). Four FGDs were conducted, 3 of them were 25 parent/guardian whose children either completed or didn’t complete the recommended 4 doses of RTS, S or didn’t receive the vaccine at all, and one with 11 community health volunteers (CHVs). The KII involved 11 healthcare providers(nurses) in charge of maternal and child health (MCH) clinics. Open ended interview guides were used for the FGDs and KIIs. Data was analyzed thematically using NVIVO software version 12.

Results:

The gaps in malaria vaccine implementation are inadequate information/knowledge about the vaccine to both parents/guardians and healthcare providers, less confidence in the vaccine due to side effects and high number of doses. Others are the poor attitude of health care providers, vaccine unavailability, understaffing of the health providers resulting in long waiting times, and migration to non-implementing sub-counties.

Conclusion:

The gaps in the implementation of the malaria vaccine; Inadequate knowledge about the vaccine, less confidence about the vaccine, poor attitude of health care providers, migrations, vaccine unavailability, long waiting queue due to staff understaffing, economic activities, cultural beliefs and inadequate trainings of health care providers.

Recommendation: Adequate health education, adequate support of the vaccine implementation program, adequate staffing and continuous training of healthcare provider. There’s need to develop strategies for implementation of the vaccine in specific settings in malaria-endemic areas for improved and sustainable RTS, S vaccine uptake.

Malaria vaccine

gaps in the implementation

low uptake

endemic area

Globally in 2021, there were an estimated 247 million malaria cases in 85 malaria-endemic countries, which accounted for over 619,000 deaths worldwide, this was a 12% increase from 2019 (1). WHO African region bears the highest burden of 95% of all cases, 96% of all deaths, and 79% in children under five (2, 3). Africa took the brunt of this burden, with an estimated 96% of all deaths, which could be preventable (4). Furthermore, 80% of the total malaria deaths in SSA were among children under 5 years old (1).

The health and economic impacts of malaria vaccines have been simulated by several mathematical models of varying complexity (5). Deterministic compartmental models have been used to estimate the impact of vaccination on malaria transmission (6, 7), and stochastic individual-based models have been employed to project vaccine-averted morbidity and mortality (8–10). In a comparison of four models (8–10), Penny et al. concluded that RTS, S/AS01 could avert a median of 116,480 (range 31,450–160,410) clinical cases and 484 (189–859) deaths per 100,000 fully vaccinated children with a four-dose schedule in Sub-Saharan Africa over a 15-year time horizon (11) .

Malaria is a killer disease in Kenya, in 2020, the country reported an estimated 27 million malaria cases and 12,600 deaths attributed to malaria (3). Malaria infection is the leading cause of morbidity and mortality in Kenya, with approximately 25 out of 35 million Kenyans (more than 70%) being at risk of Malaria (12). In every 1000 live births, 84 of them die before attaining 5 years in Kenya and malaria is the major cause of their deaths in regions where malaria is endemic(12). In 2020, malaria prevalence in children in the Lake endemic zone in Kenya was 19% (5). This prevalence is still high despite Kenya implementing several prevention strategies including chemotherapy, insecticide-treated mosquito nets (ITNs); indoor residual spraying (IRS); accurate diagnosis and prompt treatment with artemisinin-based combination therapies (ACTs); and intermittent preventive treatment of pregnant women (IPTp) (6). As a complementary strategy to the existing malaria prevention in children, on April 24, 2017, the World Health Organization (WHO) announced steps to make the RTS, S/AS01E vaccine available to three sub-Saharan Africa (SSA) countries: Ghana, Kenya, and Malawi(13). The malaria vaccine known as Mosquirix, RTS, S/AS01, or simply RTS, S is the first vaccine proven to offer partial protection against malaria(14). In 2018 WHO launched a pilot implementation in Kenya, Ghana, and Malawi to further evaluate the safety, effectiveness, and real-world implementation of a malaria vaccination program, including to understand the feasibility and uptake of the four-dose primary series vaccine schedule (15). This phase 3 clinical trial of the RTS, S/AS01 vaccine (RTS, S) demonstrated its efficacy against clinical and severe malaria in children following a four-dose schedule starting at five months(16). The vaccine showed partial protection against malaria and has been found to reduce malaria incidence by 39% and 29% severe malaria among children aged 5–17 months after taking all four doses (13). Additionally, RTS, S/AS01E vaccine was associated with a reduction in overall hospitalizations, and hospitalizations due to malaria, severe anemia, and the need for blood transfusion (17).

On Oct 6, 2021, WHO recommended widespread use of RTS, S in children in sub-Saharan Africa and areas with moderate-to-high Plasmodium falciparum transmission as part of comprehensive malaria interventions (2, 18).WHO uptake target for all the RTS, S doses is 90%(8). However, studies done have shown poor uptake of the RTS, S vaccine, especially the last two doses. A study done in Sunyani in Ghana in 2021, indicated that uptake of RTS, S 1st dose was 94.1%, 2nd dose 90.6% and 3rd dose 78.1%, no clear information about 4th dose was published (14), this shows that the third dose did not meet WHO target with no information captured about the fourth dose. A study conducted in Nigeria to assess the impact of vaccine stockouts on the uptake of vaccinations revealed that the dropout rate for RTS, S 1 and RTS, S 3 has been below 10% and this emphasizes the strong performance of the immunization program particularly in the first year of life although there are regional and district disparities (19). Occasional shortages of RTS, S vaccines at the facility level due to local distribution challenges in some districts affected availability and resulted in missed opportunities for vaccination (19).

A study done in the western region of Kenya which examined the malaria vaccine coverage estimation using age-eligible populations and service user denomination revealed that overall, service-based malaria vaccine coverage was 96%, 87%, 78%, and 39% for doses 1–4 respectively. Based on the population-derived denominator for age-eligible children, vaccine uptake was 78%, 68%, 57%, and 24% for doses 1–4, respectively (20). It is only the first dose of a service-based malaria vaccine that met the WHO target of 90%, the rest did not.

A study done in Muhoroni sub-county Kenya which was assessing uptake of RTS, S vaccine, and risk of malaria infection due to non-compliance among children 6–36 months in western Kenya showed a very poor uptake of the vaccine, the uptake was 72.1%, 66.8%,59.4% and 31.4% for the 1st ,2nd ,3rd and 4th dose respectively(21). This showed poor RTS, S uptake in this sub-county vaccine.

To achieve full vaccine protection, a child is required to receive 4 doses of RTS, S, high number of incomplete dosages as seen in various studies above is a major concern since these children won’t get full vaccine protection (2). It is very important to achieve the WHO RTS, S uptake target of 90% for all the doses (14). It is therefore important to identify reasons for low malaria vaccine uptake in the Muhoroni sub-county, an endemic area of western Kenya. By improving the uptake, the children will have full vaccine protection hence reducing malaria prevalence in children and eventually malaria-related loss of life. This study therefore investigated the gaps in the implementation of the malaria vaccine which may lead to the poor uptake of this vaccine.

Study area

The study was conducted in Muhoroni sub-county in Kisumu County, western Kenya (Fig. 1). The sub-county is located 50 kilometres east of Kisumu City and is one of the seven sub-counties in Kisumu County namely, Muhoroni, Kisumu East, Kisumu West, Kisumu Central, Nyakach, Nyando, and Seme. Muhoroni is a mostly rural area, with a total population of 154,116 individuals, 76,770 males and 77,345 females. The sub-county spans an area of 667.30 square kilometers and the major economic activities of the residents are farming, mainly sugarcane and rice and small-scale trade. The region is swampy and prone to flooding during the rainy season. Malaria transmission in the area is perennial with an annual peak in May to July during the long rainy season (22). Malaria prevalence in Muhoroni sub-county is estimated to be around 18%(23).

Study design

This study used exploratory study design. Focus Group Discussions (FGDs, n = 4) and Key Informant Interviews (KIIs, n = 11) were conducted with the purposively selected respondents. The respondents for the FGDs consisted of three categories: parent/guardian and Community Health Volunteers (CHV). Category one consisted of parent/guardian whose children completed the recommended four doses of the malaria vaccine while category two consisted of parent/guardian whose children received less than the recommended doses and category three consisted of parents/guardians whose children did not receive the malaria vaccine. The respondents for the KIIs consisted of the health facility in charge of the MCH, and county and sub-county nurse personnel in charge of vaccination. The venue for the data collection was the respective health facilities where the parents/guardians were accessing routine health services, in a secluded room with minimal interferences, and at offices of health care providers. The data collection process was iterative, involving continuous recording, translation, transcription, and interpretation of data. The following strategies with the potential to improve vaccine uptake were evaluated.

The study population

The study population consisted of 25 parents/guardians of which, 10 were parents/guardians whose children completed the recommended 4 doses, 6 parent/guardian whose children did not complete the recommended 4 doses, 9 parents/guardians whose children did not receive any RTS,S dose, 11 Community Health Volunteers (CHVs), and 11 nurses in charge of MCH services where childhood vaccines are administered.

Data collection

Data was collected using FGD and KII and the data collection tool was FGD and KII guide. There was a training on data collection and the tools were piloted in Kisumu East to test for Reliability and validity. The tools were reviewed and adjusted appropriately before the start of collection of data. Sessions were audio recorded and moderated by the investigator. Focus Group Discussions (FGDs) and Key Informant Interviews (KIIs) were used to generate information on the RTS, S vaccine. Trained qualitative research assistants assisted with the data collection and data transcription. There was a training on data collection and the tools were piloted in Kisumu East to test for reliability and validity. The tools were reviewed and adjusted appropriately before the start of collection of data. Sessions were audio recorded and moderated by the investigator. Notably, two well-experienced data analysts were tasked with the interpretation of the data.

Data Analysis

Content and thematic analysis were used in data analysis. Analysis was primarily deductive and inductive. First, the audio recordings were transcribed and translated from the local language into English. We then coded the qualitative transcripts for themes that arise from the data itself and then grouped these into different families of related themes. This is then followed by a line-by-line, micro-analysis using open coding. The codes were then assembled into potential themes and a thematic chart was developed in MS Word. The themes were compared across the transcripts and specifically the different groups, to establish the range and similarities of the participants’ perceptions and views. We coded interviews and discussions and came up with a single codebook that was used in the analysis. We used NVIVO software for analysis.

Ethical consideration

The study was approved by the Jaramogi Oginga Odinga University of Science and Technology Ethics Review Committee (JOOUST) reference number JOOUST/DVC-R10/ERC/E3 approval number: ERC36/3/23 − 05 and for National commission for Science, Technology and Innovation (NACOSTI) reference no-529996, licence no: NACOSTI/P/22/20843. Permission was obtained from Kisumu County director of health and sanitation and Muhoroni subcounty MOH before commencement of the study activities. Permission was also sought from local leaders verbally before entering in their villages. Before data collection, informed consent was sought from each study to ensure voluntary participation in the study. All necessary information about the study was explained to the participants. The purpose, risks, and benefits of the study was explained to each study participant. Further, the study participants were told that they have right to withdraw from the study at any point during the study period. Those participants who agreed to be interviewed were requested to either sign or thumbprint the informed consent form.

Socio-demographic characteristics of study participants

Out of the 36 parents/guardians invited for the group discussions, 11 of them did not turn up. All the parents/guardians who participated in FGDs were female except one (24/25) and the majority were between the ages of 20–39 years and majority (18/25) had completed primary school education. 12 CHVs were invited for a group discussion, however, 1 of them did not turn up. There was a mixture of females and males CHVs who participated in the FGDs (7 Females and 4 Males). All the 11 healthcare providers who participated in the KIIs were female aged between 20 and 50 years and all of them had tertiary education. All the nurses had tertiary education.

Sociodemographic Table 1

	Three FGD for caregivers			One FGD for CHV	KIIs for Healthcare provider (Nurses)
Category	Parents/guardians of children who completed the recommended 4doses.	Parents/guardians of children who did not complete the recommended 4 doses	Parents/guardians of children who did not take any RTS, S vaccine	None	None
Gender
Female	9	6	9	7	11
Male	1	0	0	4	0
Age
20–29	4	3	3	0	1
30–39	3	3	4	3	3
40–49	3	0	2	5	5
50 and above	0	0		3	2
Level of education
Primary completes	5	4	9	Not asked (NA)	0
Secondary complete	4	2	0	NA	0
Tertiary complete	1	0	0	NA	11

1. Reasons for Low Malaria Vaccine Uptake

The study explored the reasons for low malaria vaccine uptake through understanding their knowledge and awareness about the vaccine including the possible barriers from the perspective of the parents/guardians, the community health volunteers and the healthcare workers. The following were the reasons:

i) Inadequate Understanding of Malaria Vaccine

a) Parents/guardians and CHV perspective

Knowledge and awareness of malaria vaccine among the parent/guardian was considered inadequate with minimal information on the target audience and the vaccine dosages. The respondents portrayed a sense of disconnect between the target audiences for the malaria vaccine as they mentioned different statements. Some respondents mentioned children above five years eligible for the vaccine while others mentioned that the eligibility was children who were six months and above. Further diverse opinions on the target audience included children from six months being eligible, and children who were one year old being eligible too for the malaria vaccine. Most of the responses given by the target audience indicated there were gaps in the knowledge about who was eligible for the malaria vaccine. One thing is for sure, the respondents were aware it was to be given to children from the age of six months.

“The malaria vaccine as one of us has said, it’s a vaccine that is given to children above the age of five to protect them against malaria. The first one is given when the child is six months, the second one at eight months, the third at nine months, and the last one at 24 months.” Female 44 years parent/guardian.

The same lack of understanding was evident on malaria dosage, few respondents were aware of four doses which were given at six months, seven months, nine months, and the final dosage at twenty-four months. As noted below, other respondents were not sure of the age category mentioning the doses were given at six months, nine months, one year, and two years respectively.

“The first one is six months, the second one I think is one year, the third one is one year six months, and the fourth one is two years.” Female 31 years, parent/guardian.

b) Healthcare Provider’s Perspective

Some of the healthcare providers were able to share the target audience for the malaria vaccine stating that it was given to children from the age of six months for the first dose, the second dose at seven months, third at nine months, with the last dose given when the child is two years old. However, some healthcare workers mentioned in blanket the target audience: that the malaria vaccine was given to all under five years old, given to all children below two years, given to children between 6 months and two years, given to children who had started the vaccine at six months, defaulted but are still under five years.

“Between six months to two years. Those can be started on the injection. Or those who started, and did not complete the dosage, you can give it if they are still less than five years.” Female 36-year, healthcare provider.

Furthermore, the respondents noted that the malaria vaccine was given to children who lived in specific counties such as counties in the former Nyanza region e.g. Kisumu and Homa-bay Counties. However, there were some contrary opinions that the malaria vaccine was now available in all the counties in Kenya. Additional contrary opinion was on the timing of the dosage whereas some respondents mentioned that the vaccine could be given to children under five years, few respondents felt that a child who was above two years old and hadn’t started the vaccine yet was not fit as the target audience.

“Yes, initially when we were doing the pilot, we were saying any child below one year could start the vaccine, but in the new rollout, after the WHO gave the go-ahead to expand; the eligibility has changed to any child who is below two years, for the sub-counties that were expanded. Yes, any child below two years can be started on a malaria vaccine.” Female 51 years’ healthcare provider

Some respondents mentioned recent changes that had been made to the dosage of the malaria vaccine. They shared that the dosage guidelines were updated to allow even the children who missed the vaccine and were still under five years old to be given the vaccine, considering 4 weeks’ intervals after the first and second vaccine, and eight-week intervals for the third dosage. However, it was keen to note that some respondents had two years as the cut-off age and this contradicting information could lead to low uptake of the malaria vaccine.

“But recently we had an update, and we were told that any client that is below 5 years old should get at least four doses of malaria vaccine. If the client has not started the vaccine, we start it and then we give it four weeks apart until they finish the four doses.” Female 43 years healthcare provider.

“That one is also a barrier because you know, if I don't have enough knowledge concerning a particular vaccine, giving it is a challenge to me or talking about it.” Female 26 years healthcare provider.

The shifting of health provides from one department to the other created a knowledge gap. In most cases, a lot of changes in various health guidelines do happen during the period in which the health care provider has been shifted to another department. Unless there is consistent refresher training, the health providers are not able to adequately deliver the services.

“You will forget a lot of things. If you work in OPD for maybe three months and someone else works in OPD for one year, when you come back you will get a lot of updates. That is the challenge.” Female, 26 Years healthcare provider.

Limited Training -Training was offered to the healthcare provider at the onset of the malaria vaccine rollout. Even so, there was a need for additional information that the respondents liked to have e.g. on the management of the side effects that the parent/guardian could give at home. In most cases, the parent/guardian was advised to give the child paracetamol in case of high fevers, but again paracetamol was previously not recommended for the measles vaccine, but now the 3rd dosage of malaria vaccine was mentioned to be given together with the measles vaccine.

“I think I need to get more information about the malaria vaccine, and the side effects. Before, the information we got here was that after administering the vaccine, you inform the mother the side effect is that the baby will experience fever so you will instruct the mother to go and give paracetamol. The previous knowledge I have is that paracetamol is not supposed to be given in a particular vaccine like measles. So, I am not sure if it is correct or if it is contradicted.” Female 26 years healthcare provider.

Furthermore, the respondent mentioned the need to train on the current updates on the dosage of the malaria vaccine since there was some contradicting information on the age category.

“We still need more updates as we go on. With people sometimes we tend to forget, especially the new updates that come at first. We used to stick to the first one, but now as time goes you can forget: Female 43 years healthcare provider.

ii) Less Confidence in the Malaria Vaccine:

a) Parents/guardians and CHVs perspective

To begin with, confidence as a barrier to vaccine uptake was explored by understanding the vaccine's ineffectiveness, side effects, dosage, religious beliefs, conspiracy theories, and the health workers’ competence.

The major reason for low malaria vaccine uptake was the vaccine side effects. Most of the respondents mentioned their children experienced fever, vomiting, swelling on the arm, and appeared sick. They got discouraged once they saw the baby getting sick after receiving the malaria vaccine.

“I took my eldest child to get the vaccine. That doctor injected the child in a way that the drug went and accumulated there and got inflamed. It almost crippled my child. I went to another doctor, and he sucked them out. Even now, he walks but not properly.” Female 31 years, parent/guardian.

Some respondents shared that the number of doses was too much for a child, but the health workers kept on explaining the four doses were given at an interval and why it was important for them to be completed. The respondents were concerned with why there were many doses of malaria vaccine and the criteria unto which the decision was settled at number four. Besides, other respondents mentioned that initially there were only three doses of malaria vaccine which later changed to four.

“The doses are a lot and usually it is frightening but the question is why is it that malaria has four doses? Why do the others have one dose?” Female 46 years, parent/guardian

“There are some herbs that Luos gave to the child at birth. And that was regarded as a vaccine. So, there is no need to go to the hospital. But it is diminishing. But there are some people still using it. So, if you give birth in interior areas and you don’t have the knowledge and people in your household use it, that is the one you will use.” Female 23 years, parent/guardian.

b) Healthcare provider's Perspective

The sub-theme of confidence was exploring the respondent’s opinion on barriers to malaria vaccine uptake that were related to vaccine side effects, vaccine safety, the vaccine dosage, lack of knowledge on the vaccine, and the cultural beliefs that are affecting the confidence in the vaccine.

Side effects experienced by the children after receiving the malaria vaccine were one of the major barriers to the vaccine uptake. The respondents shared that most of the parents/guardians complained of high fevers that lasted between two to three days and convulsions after receiving the malaria vaccine. These affected the child’s sleeping and feeding patterns thus making the parents/guardians shy away from bringing their children to take the malaria vaccine. A parent/guardian of a child experiencing high fevers after the malaria vaccine could highly spread the message in the community about the side effects of the vaccine hence hindering the vaccine uptake. One of the respondents described the malaria vaccine as a rough vaccine that still needs more research.

“The first time the malaria vaccine was introduced, there was a neighbor’s child who was vaccinated, and you know the side effects like the fever, when they saw that, they decided that their child would not be vaccinated, we have tried to talk to them but till now they do not want it, so what can we do? They have refused, not because of religion, it is just by seeing the neighbors’ child and thinking that their child will also experience the same thing.” Female 43 years healthcare provider.

There were mixed feelings about the dosage of the malaria vaccine as a barrier. The respondents shared that some of the parents/guardians upon explanation of the four dosages of the malaria vaccine took the instruction carefully and did not have a challenge. On the contrary, some parent/guardians felt that the four doses of malaria vaccine were a lot with the last dose stretched way too far after the child had completed all other routine vaccinations.

“The number of doses…maybe what could bar the guardian from bringing the child is just the separation between the 3rd and the 4th dose. Yes, because it’s almost a year apart; it is 1 year and 2 months apart because from 9 months to…that one month close to three months apart. So, up to 2 years. So, you realize that by that time I would have forgotten as a parent that I need to be taking my child back for the 4th immunization. But still, we see parents coming back, “Oh, it’s 2 years”, they are coming for a jab.” Female 37 years healthcare provider.

There was constant staff turnover that led to a shift in the person offering the malaria vaccine from the trained one to the untrained one. In most cases, the untrained one received orientation or on-the-job training and was not fully equipped with all the knowledge and mostly could find challenges related to vaccine preparation and vaccine administration.

“OJTs are job training like the works that we’re doing onsite, yeah, so yes, it could be a barrier it is it is a barrier because then they are not having adequate information in terms of in terms of the vaccine, in terms of the vaccine itself, what to tell the client what not to tell the client things like those, yeah.” Female 43 years healthcare provider.

The respondent noted that vaccine safety was not a barrier as it was considered safe for use, however, there were cases of concern about vaccine safety during the pilot being that the malaria vaccine was piloted in selected sub-counties.

“Just as I have said before, during the pilot time, most mothers were hesitant because they thought it was not safe since we were a pilot sub-county, but as of now, they feel it is safe.” Female 41 years healthcare provider.

Other confidence-related barriers included the number of vaccines which the caregivers felt has so far increased, thus leading to a lot of defaulting cases, lack of confidence in the vaccine because of the religious and cultural values

“They just refuse, they tell you that their religious beliefs do not allow them to be given the vaccine, but we don’t just leave it at that, we send the CHVs to talk to them, if it is beyond the CHVs we send the community health extension workers just to find out what could be the problem.” Female 53 years healthcare provider.

iii) Inconveniences in getting Malaria Vaccine

a) Parents/guardians and CHVs perspective

Convenience as a barrier explored factors around the health facility-related, and social economic aspects that contributed to the low vaccine uptake.

To begin with, healthcare providers-related barriers such as negative attitudes was one of the reasons for the low vaccine uptake. The respondents noted that some healthcare providers weren’t talking politely to the caregivers hence discouraging them from taking their children for the vaccine. Moreover, the lack of provision of information about the vaccine was mentioned to be a barrier to its uptake. Some respondents shared that when they took their child to the health facility, some of the health workers did not provide information about the vaccine.

“You know these are our children and this is a vaccine that I as a parent, have taken the responsibility to bring him/her. And I am getting it for the first time. I ask you as the nurse present…I should be explained to before I consent to the child to be given. I cannot consent to the child being injected with something I don’t know or am not aware of. But you get that some are not courteous enough to explain to you. She tells you, “You are not aware of the vaccine?”. As far as I am aware, I should have the information about the vaccine. I might be aware that there is a vaccine for malaria but what is the purpose or why am I being vaccinated?” Female 29 years, parent/guardian.

There were some cases when the vaccine was not available in the health facility. The respondents mentioned that sometimes they were told either to come back after two weeks or to go to Kisumu because their respective health facilities did not have the vaccines. Besides, some of the health facilities had estimated timelines at which they were giving the vaccines. Once the timeline elapsed, the caregivers were turned away.

“You can go, and you find the vaccine unavailable. Most of the hospitals don’t have the vaccine.” Female 28 years, parent/guardian.

Time taken at the health facilities which was coupled with long queues in most cases discourages the caregivers from taking up the malaria vaccine thus the low vaccine uptake. Could be there were other parallel errands that the caregiver was supposed to be doing but instead took the whole day at the health facility.

“Another barrier is that sometimes they go to the facility when there are so many clients, and so they have to stay in the queue from around nine in the morning till two in the afternoon, this discourages them because they think that the next time, they go back they will find a long queue.” Male 35 years CHV.

Distance to the health facility was a barrier in areas where the health facility was located outside the locality of the community. In most cases, the roads become impassable during the rainy seasons and the parents/caregivers may opt not to take their children for the vaccine.

“Like it had been said, maybe you lived near the hospital and maybe you moved and went far away from the hospital. So, you may lack the fare to go.” Female 31 Years, parents/caregivers.

There were instances of language barriers in cases where the parents/caregivers were only familiar with the local language and the health provider at the facility was a non-native and this was mentioned to be a barrier to the malaria vaccine uptake. The parents/caregivers did not feel comfortable expressing themselves to the health providers given the struggles with the language.

“There are those who don’t have understanding; when you don’t go to school there are so many things that don’t make sense to you. So, that is a barrier, there will be a knowledge gap even for those who are giving health talks. Some people you’d think have received what you’ve said but they didn’t understand. And sometimes you are insensitive to maybe use a different language.” Female, 26 years parent/guardian.

Male partners were hardly available in the homes therefore equipping them with knowledge about the vaccine was not easy. Furthermore, there were times when the male partners were not supportive in terms of not offering transport to the health facilities.

“It also depends on our partners. You can tell him, “Tomorrow I need to take the child to the clinic”. And he tells you he doesn’t have the fare. And you can’t walk to and from the hospital. You will end up not going.” Female 23 years, parent/guardian.

Additionally, in instances where a community has less information and the people around do not take their children for malaria vaccine, may hinder its uptake. The caregivers may fail to know about the malaria vaccine and thus not avail their children of the same. Furthermore, some parents/caregivers had children before the introduction of the malaria vaccine, they think that the malaria vaccine is too much.

“Those partners who had children before know the schedule for the other vaccines and when they get another child and the malaria vaccine is added to the schedule, they think that it is too much.” Female 40 years, CHV.

Other barriers are the few staff at the health facility, there are few staff in the facilities making time spent during vaccination services to be longer since they will be attending to other patients or there will be no service provision when they don’t show up at work. Lack of permission from work may also hinder the parents/caregivers from taking their children for malaria vaccine.

“Most of our dispensaries have only one nurse. The nurse can go for a meeting or training this means that when a parent/caregiver comes there will be no one to serve them.” Male 40 years parent/caregiver.

Healthcare provider’s Perspective

Health facility related barriers such as longer waiting time, distance to the health facility, and health worker’s attitudes in addition to socioeconomic-related challenges such as economic activities and, the role of partners, were used to explore convenience as a barrier to vaccine uptake. The sub-theme convenience had the highest number of references at one hundred and three coded in all the eleven scripts.

Long waiting time at the health facility -This was a major barrier to the parents/guardian. This was attributed mostly to the shortage of staff that resulted in one staff providing services to many clients.

Another barrier would be, maybe, we would have, because of the staff shortage, in our facilities, you may find long waiting time for the clients. When they come, they may take a long, if it is one worker giving the vaccination, it’s the same worker doing the treatment, it’s the same worker doing the antenatal services. So, the healthcare worker will be moving from there, to here, to here. So, a mother may stay for long, before they get the services. So, they may walk out and go home and not get the service or, they may wait and maybe not come next time to get the vaccine “Female 51 years healthcare provider.

High workload especially in high-volume health facilities –This resulted in the exhaustion of the health workers who were not able to adequately create time to handle health-related issues of the caregivers concerning the malaria vaccine. The high workload was also experienced in health facilities that were understaffed and the health workers did not have enough time to explain to the mother malaria vaccine-related information that could boost the uptake.

“At times we do have, on Wednesdays and Fridays have high number of clients so when someone is exhausted, getting time to address some issues like malaria vaccine and talking to the parents about it, the time is limited.” Female 26 years healthcare provider.

Health workers’ negative attitude –This made the caregivers feel uncomfortable to bring the child for the next dosage of the vaccine. The respondents noted that unfriendly health workers were a barrier to the caregivers honoring their next visit.

“Also, attitude contributes to the uptake of the vaccine. If a mother comes and maybe I have an attitude, she will feel like this nurse is not that friendly. So, you find that she won’t come back after that six month, she will wait until the baby reaches nine months is when she will come for the measles vaccine, and then from there maybe you might talk to her to give the first dose of malaria and then she will just go away like that, and she will not come back.” Female 26 years healthcare provider.

Vaccine Unavailability- Other health facility-related barriers included vaccine unavailability, especially in health facilities that experienced power outages. This then made the healthcare workers to outsource the vaccine to nearby health facilities that had reliable power.

“Storage is also fine because we have electricity most of the time. Maybe occasionally, we don’t have and if we don’t, we transfer to the next facility that has electricity. Female, 51 Years healthcare provider.

Staff Turnover-Shifting of health workers from one department to the other created a knowledge gap. In most cases, a lot of changes in various health guidelines do happen during the period in which the health worker has been shifted to another department. Unless there is consistent refresher training, the health workers are not able to adequately deliver the services.

The role of male partners who decided on whether the child could receive the vaccine or not wasn’t predominant as most of the men were not involved in child welfare directly.

“Only females come. It is hard for the male to come. Occasionally they usually come with their wives but most of the time the mothers come on their own. Female, 36 Years healthcare provider.

Economic factors such as routine activities were mentioned to be barriers as most of them were undertaken during the morning hours thus conflicting with the vaccination schedule. Most of the health facilities scheduled their vaccination activities to take place in the morning hours and the malaria vaccine is only potent for six hours after vaccine preparation, this then made it not possible for the caregivers who had to first attend to their routine activity to get the malaria vaccine. The caregivers gave priority to their routine activities and then later took their children for immunization.

The routine activities are also a contributing factor but as mothers, we do give immunization up to a particular time, some vaccines are only portent for six hours, so we will tell them to make sure they come before 1:00 pm or 12:30 midday and if a mother comes past that time, that day she will miss the vaccine. If you tell them that they can come tomorrow or the following day, then they feel like it’s a challenge.” Female 26 years healthcare provider.

Poor road infrastructure made some of the health facilities difficult for the caregivers to reach this was contrary to some instances where the respondent mentioned the health facilities were located closer to the residential areas in the community. For the cases where the health facility was located far away, challenges related to transportation means were noted to be barriers to malaria vaccine uptake.

Migrations. - The study area was originally a settlement scheme that was characterized by a lot of migrations, thus affecting the uptake of the vaccine. Another migration was seasonal for example during the Christmas season, some of the caregivers who were living in the semi-urban centers would move to the rural area.

“Yes, this is a settlement scheme, clients tend to move from one place to another. You find that even in the permanent register, they are giving you a phone number but when you call, you will not find that client, you don’t know where they have gone.” Female 43 years healthcare provider.

Age, education level, and Ignorance were mentioned not to be barriers to malaria vaccine uptake. Some of the unlearned persons were not able to comprehend the importance of the malaria vaccine as compared to the learned ones. The same applied to some of the younger caregivers especially those who were still in school and did not have an easy time understanding the importance of the malaria vaccine. The respondent mentioned that some of the younger parents/guardians would like their children with their grandmothers who may fail to remember to bring the child for vaccination. Some of the caregivers were ignorant about the vaccine because of the knowledge.

“Okay, for education status, those who are learned or a bit learned know the importance of immunization, once you talk to them, they will understand and they will cooperate but then those who are not learned, it is a challenge to convince them and maybe to discuss to them about the vaccine. Sometimes we can just talk about ignorance, some people are learned but then they will be like, some ten years back the vaccine did not exist, but people were just okay, so why now?” Female 37 years healthcare provider.

iv) Lack of Complacency

a) Parents/guardians and CHVs Perspective

Barriers related to the feeling of not being at risk of contracting malaria were mentioned in brief. The respondent narrated how at one point the community members shared they were not at risk of contracting malaria as compared to their counterparts in the Nyando area who were prone to living in areas with a lot of mosquitoes.

“When the vaccine started, before anyone understood the importance of the vaccine, we were trying to reach out. Our people within Muhoroni were complaining that we were talking to them about the vaccine instead of reaching out to those in the Nyando area where there are a lot of mosquitos.” Female 44yrs CHV.

b) Any other additional barrier

There were cases where parent/guardian was disabled and there wasn’t anyone to stand in and take the child for the vaccine. Other barriers included when the child was too sick, when the mother failed to go for ANC during pregnancy, and misplacing/forgetting the MCH booklet. These made parents/guardians do not take their children for vaccination.

“What we can add as a barrier is that some caregivers are abled differently, so communicating with the health providers becomes a problem.” Female 56 years parent/guardian.

Additional barriers included packaging of the information on the malaria vaccine, community-based advocacy, vaccine rolled out in specific counties leaving out some malaria endemic zones, lack of an MCH booklet that didn’t include the malaria vaccine initially, and training of the CHVs.

“I think at first during the pilot time they should have taken more resources at the community level so that the information could be cascaded from the household coming up not from us downwards. With that, we could have not encountered more resistance.” Female 41 years healthcare provider.

This study identified the gaps in the implementation of the RTS malaria vaccine leading to low uptake even though the malaria vaccine has shown a positive effect in our study site and elsewhere(14). The inadequate knowledge and awareness about the vaccine came out to be a major gap in the vaccine uptake. Parents/Guardians have inadequate understanding of the malaria vaccine as there was a disconnect between the age eligibility and the number of doses to be taken at what age. Similar concerns were raised in a qualitative longitudinal study which was looking at RTS, S/AS01 malaria vaccine pilot implementation to understand immunization barriers and optimize uptake. The study found reasons for initially delaying the uptake of the vaccine included a lack of awareness and incorrect information about the malaria vaccine(15).

Limited training and refresher training also cause health providers to miss some changes and information about the malaria vaccine. These results showed a lack of uniform information about age eligibility for malaria vaccine among healthcare providers which was brought by a lack of training and refreshers to be at par with changers. These findings are like those of a study conducted in Ghana among healthcare providers to assess the success and challenges of the malaria vaccine implementation program (MVIP) and to provide recommendations for the introduction of new vaccines in the future. The study revealed that less than half [46.3%; (25/54)] of the vaccinating staff received pre-vaccine introduction training but almost all [94.4%; (51/54)] were able to constitute and administer the vaccine appropriately (24).

Less confidence about the vaccine also played a huge role in poor malaria vaccine uptake. Parents/Guardians’ confidence was lowered by the vaccine side effects, most of the respondents mentioned their children experienced fever, vomiting, swelling on the arm, and appeared sick. They got discouraged once they saw the baby getting sick after receiving the malaria vaccine. This made them miss the subsequent doses or not start the vaccine at all. Vaccine side effects have been mentioned in several studies as one of the major barriers to malaria vaccine uptake as it is distressing for parents/guardians to see their children endure pain or become paralyzed (13, 25).

Furthermore, the number of vaccine doses was a barrier since some respondents shared that the number of doses was too much for a child. Their concern was that the 4 doses were many and one could easily forget especially with the 4th dose. Since there is no vaccine being given at 24 months, without a reminder, parents/guardians might forget. The same findings were found in a study done in Ghana which explored the perspectives of defaulters and frontline health service providers which reported that for most mothers, the timing of the fourth dose presents a major challenge since the last vaccine in the EPI is taken in the 18th month, uptake of the fourth dose of the RTS, S at 24th months was affected (13). Another study in Ghana which explored the Challenges and lessons learned during the planning and early implementation of the RTS, S/AS01E malaria vaccine in three regions of Ghana reported that many of the health service managers and frontline health providers described the timing of the 4th dose of RTS, S/AS01E, given at 24 months of age, as a major challenge. Participants explained how the 15-month gap between the 3rd and 4th doses was too large for parents/guardians to remember to return to the vaccination clinic and that vaccinations given in the second year of life have poor coverage. Multiple participants discussed how they would have preferred this gap to be shortened, and that the 4th dose be combined with MCV-2 at 18 months (26).

Religious and cultural beliefs also contributed to the lack of confidence in the malaria vaccine hence the low uptake. There were rumors that the government had an unknown agenda with the vaccine because there were too many vaccines being introduced. Furthermore, cultural practices such as the use of herbal medicine made some of the respondents lack confidence in RTS, S vaccine. These findings were similar to the findings of a study to assess the barriers to implementation and uptake of the malaria vaccine in Ghana that found that there was poor acceptance of the vaccine by the population. The study revealed that the majority [92.5%;(87/94)] of caregivers were aware of the RTS, S introduction but only 44% (41/94) had accurate knowledge of the number of doses needed for maximum protection. More than 80% [87.5%; (47/54)] and 95.8% (90/94) of healthcare providers and parents/guardians respectively accepted RTS, S (27).

The negative attitude of the healthcare providers came out too as one of the barriers to RTS, S uptake. The respondents noted that some health providers weren’t talking politely to the parents/guardians hence discouraging them from taking their children for the vaccine. Health providers also acknowledge some of their colleagues have bad attitudes towards the parents/guardians. However, they said this attitude could be brought about by high workload and pressure due to understaffing. They said that some staff when overwhelmed with a huge workload, tend to show some bad attitude. This barrier was also reported in a study done in Kenya to understand immunization barriers and optimize the uptake of RTS, S(15). When a parent/guardian misplaces the MCH booklet or forgets about the dates, they fear going to the clinic due to cruel health providers. Long queue and long waiting times at the MCH clinic plays another role in lowering RTS, S uptake. Parents/guardians complained of taking too long to get vaccines due to long queues due to few health providers at the MCH. Understaffing was acknowledged by some of the health providers during KII as they said that there is a staff shortage which makes health providers at the MCH also provide services at the outpatient department. This makes mothers take a longer time before getting services. Distance to the health facility and bad terrain were a barrier in areas where the health facility was located outside the locality of the community. In most cases, the roads become impassable during the rainy seasons and the caregivers may opt not to take their children for the vaccine. Economic factors such as parents/guardians going to work in the morning give priority to a source of income as compared to taking the children for vaccination. This was coupled with a lack of male partner involvement in providing financial support in terms of transport for vaccination. A review done to understand the acceptance, availability, and feasibility of RTS, S/AS01 malaria vaccine pointed out lack of transport and long distance to the facility as barriers to RTS, S uptake (25). Other health facility-related barriers included vaccine unavailability, especially in health facilities that experienced power outages and those lacking adequate cold chain equipment like refrigerators. This makes providers reschedule the parents/guardians for another day when the vaccine is available. This demoralizes parents/guardians and some of them don’t come back on the rescheduled date. A study done to identify challenges and lessons learned during the planning and early implementation of the RTS, S/AS01E malaria vaccine revealed that lack of functioning cold-chain equipment in health facilities, including insufficient and inadequate refrigerators, vaccine carriers and thermometers are among the barriers to RTS, S uptake (26). Furthermore, Migration also played a huge role in poor RTS, and S uptake since some parents/guardians would move from implementing areas to non-implementing areas. This made children miss this vaccine since most of the time a child comes back to implementing areas when they are over age or sometimes, they don’t come back at all. A longitudinal qualitative evaluation study for the malaria vaccine implementation program which was done to identify acceptance and adherence to a four-dose RTS, S/AS01 Schedule also reported a lack of access to the vaccine when parents/guardians traveled to locations outside of the pilot regions as one of the reasons as to why children missed RTS, S doses(2).

Limitations of the study

This is a study in a sub-county within the peri-urban setting in Kisumu County and therefore the findings might not necessarily reflect the situation in the other implementation counties in Kenya.

We conclude that there is inadequate knowledge about RTS,S vaccines, less confidence by parents/guardians about the malaria vaccine due to its side effects and the many number of doses, and bad attitude of health care providers is making parents/guardians shy away from going for vaccination .Others include long queues at the clinic as a result of understaffing, and movement due to economic activities resulting in the missing of doses. Migration, vaccine unavailability causing re-scheduling of dates as well as inadequate refresher training of health care provider also came out as barriers for RTS, S uptake.

RECOMMENDATIONS:

We recommend adequate health education for both parents/guardians, healthcare providers and public at large about RTS, S malaria vaccine. There is a need to explore techniques and harmonize the vaccine schedule to manage the possible adverse effects and many number of doses. There is also a need to explore task shifting and integration of the services to manage the workload for healthcare providers. There is a need to come up with a vaccine implementation strategy that not only targets the malaria vaccine but another vaccine too. There is need for resource mobilization to support the implementation of the vaccine to always make vaccine available in all the facilities.

Funding

This research was supported by the Capacity Development of Applied Epidemiologists in the Eastern Africa Region (CDAE). This project is part of the European and Developing Countries Clinical Trials Partnership II (EDCTP2) Programme supported by the European Union. CDAE is jointly implemented by the African Population and Health Research Center (APHRC), the Amref International University (AMIU) and the Jaramogi Oginga Odinga University of Science and Technology (JOOUST) and funded by the EDCTP2 (grant: CSA2020E-3139).

Acknowledgment

We gratefully acknowledge the European and Developing Country Clinical Trials Partnership (EDCTP) for funding this research. Special thanks to Jaramogi Oginga Odinga University of Science and Technology School of Health Sciences Department of Public and Community Health for their support during this study. We acknowledge the Ministry of Health Kisumu County and Muhoroni sub-county for their assistance during the study, we too acknowledge research assistants who took part in data collection. This study was also made possible through the help of community health volunteers who introduced us to the community. Lastly the authors thank all caretakers from Muhoroni sub-county who actively participated in the study.

Conflict of interest

The authors declared no conflict of interest.

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No competing interests reported.

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Gaps in the implementation of RTS, S malaria vaccine contributing to the low uptake in an endemic area of western Kenya

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Abstract

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INTRODUCTION

MATERIALS AND METHODS

Study area

Study design

The study population

Data collection

Data Analysis

Ethical consideration

RESULTS

Socio-demographic characteristics of study participants

Sociodemographic Table 1

1. Reasons for Low Malaria Vaccine Uptake

a) Parents/guardians and CHV perspective

b) Healthcare Provider’s Perspective

a) Parents/guardians and CHVs perspective

b) Healthcare provider's Perspective

a) Parents/guardians and CHVs perspective

Healthcare provider’s Perspective

a) Parents/guardians and CHVs Perspective

b) Any other additional barrier

DISCUSSION

Limitations of the study

Conclusions

RECOMMENDATIONS:

Declarations

References

Additional Declarations

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