Vaccine 32 (2014) 6157–6162

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Parental acceptance of inactivated polio vaccine in Southeast Nigeria: A qualitative cross-sectional interventional study Beckie Nnenna Tagbo a , Maduka Donatus Ughasoro b,∗ , Dorothy Omono Esangbedo c a b c

Institute of Child Health/Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria Department of Paediatrics, University of Nigeria Enugu Campus, Enugu, Nigeria Paediatric Division, Providence Hospital, Ikoyi, Lagos, Nigeria

a r t i c l e

i n f o

Article history: Received 2 June 2014 Received in revised form 21 August 2014 Accepted 25 August 2014 Available online 16 September 2014 Keywords: Acceptability Childhood immunization Inactivated polio vaccine Nigeria

a b s t r a c t Background: The introduction of inactivated polio vaccines (IPV) is imminent. In view of the Polio Eradication and Endgame Strategic Plan 2013–2018, parental acceptance of IPV will be important for achieving universal coverage. In view of the imminent introduction of IPV, it is only reasonable to assess the awareness and acceptance of IPV, so that necessary socio-anthropological measures would be put in place. This study is aimed at determining the level of awareness and acceptance of IPV by parents. Methods: A cross-sectional study involving 408 parents that brought their children for immunization. Structured-questionnaire was to collect data on the parent’s demographic characteristics, awareness and acceptance of IPV. The independent factors that may affect parental acceptability of IPV were evaluated using linear regression analysis. Results: About 53% of the parents had no knowledge of vaccine content and 84.1% had not heard of IPV, and 40.2% were willing to accept IPV. However, with post-intervention (IPV) health education, the level of acceptance of IPV increased to 95.6% and the difference was statistically significant (p = 0.0001). 35.3% expressed fear for IPV, and 61.8% cited fear for pain (61.8%). In the rating scale of 1 to 5, doctors (4.7), Nurses (4.0) and staff of the Ministry of Health (4.0) were rated high as reliable media to inform them about a new vaccine. The logistic regression revealed only educational level of mothers (p-value = 0.048) was the only significant factor associated with acceptability of IPV. Conclusion: The parents’ knowledge on vaccine was poor, as well as IPV acceptability (pre health education). But the acceptability was improved with provision of extra information. Although most still preferred OPV, and with improvement in pain management, acceptability of IPV can be improved further. Clear policies and strategies should be immediately developed and implementation of pre-introduction awareness/sensitization on IPV should be commenced. © 2014 Elsevier Ltd. All rights reserved.

1. Introduction Global introduction of live-attenuated oral poliovirus vaccine (OPV) has contributed immensely to the reduction of cases of poliomyelitis [1,2]. The major contributor to this high achievement of OPV are its low cost and the ease of administration [3] that have enabled effective use in mass campaigns and also its ability to confer herd immunity, a situation in which the chances of infection in unimmunized children are drastically reduced when many other children in the neighborhood receive the vaccine [4–6]. Herd immunity is pivotal in the fight to eradicate poliomyelitis. Presently, there is a global push for the elimination of poliomyelitis

∗ Corresponding author. Tel.: +234 8060388863. E-mail address: [email protected] (M.D. Ughasoro). http://dx.doi.org/10.1016/j.vaccine.2014.08.053 0264-410X/© 2014 Elsevier Ltd. All rights reserved.

in different geographical regions and subsequently, for worldwide eradication. Polio elimination means that the chance of secondary infections from an infected individual is below one in different regions, and eradication means a permanent reduction to zero of the worldwide incidence of the infection [7,8]. Elimination has been achieved in most developed countries and is gradually extending to some developing countries. The Polio Eradication and Endgame Strategic Plan 2013–2018 advocates for countries where elimination have been achieved to switch over to inactivated polio vaccine (IPV); and for endemic areas such as Nigeria, to include at least one dose of IPV in addition to OPV in the immunization schedule for poliomyelitis. Although OPV has added benefits other than the ease of its administration [3] that made it ideal for mass immunization campaigns, the potential risk of its continued use in the post-eradication era outweighs its benefits. This is because of the potential for the vaccine virus

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to revert to neurovirulence and become transmissible circulating vaccine-derived poliovirus (cVDPVs) [9,10], and the occurrence of vaccine associated paralytic poliomyelitis. In other to achieve eradication [11] and prevent potential outbreak of poliomyelitis, the introduction of IPV into the immunization schedule for poliomyelitis is being advocated. There are two strategies to the cessation of the use of OPV. First is the utilization of IPV to protect against outbreaks of wild-type or vaccine-derived poliovirus in areas where wild poliovirus has previously been eliminated such as in developed countries. A second strategy is the use of IPV in combination with OPV in places where wild polio is still being transmitted and OPV is still being used in the immunization schedule as in developing countries [12]. The latter strategy was recently implemented in Kenya, when an incidence of wild poliomyelitis virus-1 infection that was genetically linked to a virus originally from Nigeria was reported in a refugee camp in Kenya. In response, a national and five sub-national OPV and IPV combined campaigns were conducted in the five refugee camps and surrounding communities in Kenya [13]. This was a frantic effort to boost the immunity and protect the community. Such intervention may be imminent in Nigeria, considering the sub-optimal coverage achieved in the polio immunization program and the impact of security disturbances in the northern part of the country on the program. Strategically, the combination of IPV and OPV is recommended even in areas that are yet to eradicate polio, considering the reported increase in both mucosal and humoral immunity to the three serotypes of poliovirus, when IPV is used in combination with OPV [14,15]. Presently, the cases of wild polio are reported in only three endemic countries of the world: Nigeria, Afghanistan and Pakistan. As a component of the Polio Eradication and Endgame Strategic Plan 2013–2018, the use of OPV will cease in the post wild polio eradication era, and IPV will be introduced in 2015 into the routine immunization schedules of 126 nations that still have OPV as the only vaccine against polio in their program [16,17]. This means that IPV will be introduced in the routine immunization schedules of many middle- and low-income countries. In view of this, Global Polio Eradication Initiative (GPEI) encouraged the development of an” affordable” IPV [18]. The principal concern with the introduction of IPV in areas where OPV was initially in use is the potential for poor acceptability of the vaccine by parents. This could lead to a drop in coverage and the risk of poliomyelitis outbreak, causing a drop in achievement made over the decades and antecedent loss in trust of the immunization program. Also of concern is the issue of suitable media to communicate such change to avoid damaging rumor, as well as address the issue of adverse events and pain: issues that if not well handled can affect the effective deployment of IPV. This study is a qualitative and interventional study of parental acceptability of IPV. The outcome of the study has given insight into the level of acceptability of IPV and the potential obstacles to its introduction; outcomes that should guide the program managers in the preparation for the introduction of IPV.

2. Methods 2.1. Study sites and population This is a cross-sectional hospital facility-based study of parental acceptability of IPV for their children. The study sites are Immunization centers of the University of Nigeria Teaching Hospital Enugu, Enugu State and the Federal Medical Centre, Umuahia, Abia State. Children are immunized at these centers two to three times a week. The parents are always given health talk before vaccines are administered to their children. The respondents in this study are parents

that brought their children to the hospital for immunization, who gave their consent to participate in the study. 2.2. Sample size The sample size was calculated on the basis of 81.3% participation as reported by Williams et al. [19] in their randomized study of 369 respondents on how to increase acceptance of childhood vaccines by vaccine-hesitant parents, and computed with power of 80% and confidence interval of 95%. 2.3. Data collection An interviewer administered the questionnaire used for the study that lasted from January to April 2014. The information collected were age, gender, marital status and educational level of parents, occupations of both parents, number of their children, whether any child in the family had received vaccination, as well as their knowledge of vaccines, its side effects and reason for vaccinating children. The parental preferred medium of getting update on health related issues were quantified via 5-item Likert scales: 5—strongly agree, 4—agree, 3—don’t know, 2—disagree, and 1—strongly disagree. The preference assessment “score” for each individual medium was calculated by adding the individual scores given for each medium by the respondents as numerator, and dividing it by the total number of the respondents that scored that medium as denominator to get the average. The interviewer, mid-way through completing the questionnaire, educated parents on IPV: its content, route of administration, and reason for its introduction and possible adverse events, which include: pain and local inflammation at the injection site. After that the respondents were asked to re-state whether or not they will allow their children to receive IPV and which of the 2 vaccines they preferred, OPV or IPV. Their responses were documented. Ethical approval was obtained from Ethics and Health Committee of the University of Nigeria Teaching Hospital Enugu. Written informed consent was obtained from each parent. 2.4. Data analysis Certain variables: parental age, number of children and educational levels were categorized to create binary variables. The age was grouped into 34 years and below and 35 years and above, the number of children was also put into two groups of one child and two or more children, the educational level into secondary school or less and tertiary education. The reason for categorizing the number of children into two groups of one child and two or more children, is that couples with only one child that is still receiving vaccine and are yet to complete all the immunization are not as exposed and informed on vaccine related issues compared to couples with two or more children, who have seen at least one of their children complete recommended immunization. The respondents were asked to score different medium of communication from “1” to “5”, where “1” is the lowest and “5” is the highest. Their responses to the questions on whether to accept IPV or not, were grouped with their responses prior to and after the health education. Multivariate regression analysis was used to test the association between IPV acceptability and some predictor independent variables. p-Value of < 0.05 was taken as significant. 3. Results A total of 426 respondents were approached for interview and 6 respondents refused to participate. Of 426 potential respondents, 420 were surveyed resulting in a cooperation rate of 98.6%. Among the 420 respondents that accepted to participate in the study, 12

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questionnaires had to be excluded from analysis, due to incomplete data essentially from caregivers/parents that excused themselves for their children to receive their vaccine and never came back to complete the survey. The age range of all the respondents was 18 years to 55 years, mean age of 30.1 years with standard deviation of 4.9 years. 322 (78.9%) of the respondents were within the age range of 26–35 years, 403 (98.8%) were female and 300 (73.5%) had tertiary education. 86.8% indicated that the decision to receive immunization was taken by the couples together (Supplementary Table 1).

3.1. Parental general knowledge about vaccines and IPV acceptability The respondents that did not have any idea about the content of a vaccine were 215 (52.5%) while 39 (9.3%) knew the correct content of vaccines. However 203 (49.8%) of the respondents knew that vaccines are for prevention of major illnesses, as against 169 (41.4%) that said that vaccines are for prevention of all the illnesses (Table 1). The respondents that knew that vaccines have side effect were 209 (51.2%). 382 (93.6%) would still vaccinate their children even if side effects occurred in the preceding vaccines received. The respondents that had heard of IPV were 65 (15.9%) and 164 (40.2%) would accept their children to receive IPV instead of OPV. However, after the respondents received information on IPV, 391 (95.8%) acceptability was recorded and the difference between pre and post health education responses was statistically significant (p = 0.0001) (Fig. 1).

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Table 1 Parental general knowledge about vaccines and IPV acceptability. Variables Content of vaccines? Chemical Harmful materials Don’t know Reason for vaccination? Treat Diseases Prevent all illnesses Prevent major illnesses Don’t know Do vaccines have side effects? Yes No Vaccinate even with side effects? Yes No Heard of IPV Yes No Receive IPV instead of OPV (prior to information on IPV)? Yes No Receive IPV instead of OPV (post exposure to information on IPV)? Yes No

n = 408

%

156 39 215

38.2 9.3 52.5

27 169 203 9

6.6 41.4 49.8 2.2

209 199

51.2 48.8

382 26

93.6 6.4

65 173

15.9 84.1

164 244

40.2 59.8

391 17

2

p-Value

289.3

0.0001*

95.8 4.2

* Statistically significant (willingness to receive IPV instead of OPV pre and post exposure to information on IPV.

3.3. Differential acceptability of IPV according to predictors 3.2. Respondents expressed concern over IPV introduction Fig. 2 shows that before information on IPV was provided to the respondents, 120 respondents expressed concern over the introduction of IPV, out of which 74 (61.8%) expressed concern over injection associated pain. Other concerns expressed were on whether trained vaccinators are going to be used 28 (23.3%), risk of abscess from injection 20 (16.7%), and paralysis from injection 14 (11.7%). Those that still preferred OPV for its ease of administration were 14 (11.7%).

The overall acceptance of IPV was relatively the same for all the predictors except for the mother’s educational level which has a higher acceptance of 58.8% for those that completed tertiary education and 50% for those that completed secondary education or less (Fig. 3). However, when they were exposed to information on IPV, all recorded almost 95% acceptability. Multivariate analysis indicated that there was statistically significant difference between IPV acceptability and maternal education status (p-value = 0.048) (Table 2).

Fig. 1. Sample selection framework.

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70.00% 60.00% 50.00% 40.00% 30.00% 20.00% 10.00%

Percentages (%)

0.00%

Fig. 2. Respondents expressed concern over IPV introduction.

HHZ—household size.

Mothers' Age (≥35 yrs) Mothers' Age (≤34 yrs) Mothers' EducaNon TerNary Mothers' EducaNon Secondary or less

Post--InformaNon (%) Pre--InformaNon (%)

HEARD OF IPV VACCINES SIDE EFFECTS HHZ≥2 HHZ≤1 0.00%

20.00%

40.00%

60.00%

80.00%

100.00% 120.00%

Fig. 3. Differential acceptability of IPV vaccine according to different predictors. LG: local government, SG: state government, FG: federal government, TBA: traditional birth attendants.

Fig 4 shows the scale rate (1–5) of the different media of communicating information on new vaccine by the respondents. Their scores were as follows: doctors (4.9), nurses (4.0) and certified staffs of Ministry of Health or National Primary Health Care Development Agency (4.0), school teachers (2.2) and traditional rulers (2.2), traditional birth attendants (1.5).

Table 2 Multivariate regression analysis of independent predictors that can influence acceptability of IPV among parents. Independent variables

Coef.

SE

Sig.

Age in years (≤34 and ≥35) Number of children (1 and ≥2) Mothers’ education (Primary or less & secondary and above) Know vaccines to have side effects (“Yes” or “No”) Heard of IPV (“Yes” or “No”)

−0.002 −0.014 −0.143

0.008 0.036 0.071

0.808 0.704 0.048

0.115

0.070

0.105

−0.073

0.095

0.0447

Coef.: coefficient, SE: standard error, Sig.: significance.

4. Discussion This study revealed that most parents do not have adequate information on vaccine content, its purpose of administration, and

Doctors 5 4 3 2 1 0

TradiNonal Rulers School Teachers Religious Leaders

Nurses TBA Scale Rate Radio/TV

MOH/NPHCDA

LG SG

FG

Fig. 4. Scale rate of different media to communicate information on new vaccine.

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its side effects. This is similar to what has been reported [20–23]. Parents’ knowledge of vaccine is often poor, and the little they do have is often wrong [23]. However, there is no association noticed between the parents’ knowledge and vaccination coverage rates [23] and the community still accepts vaccine despite the inadequacy in their knowledge [24]. This may be the explanation for the reasonable immunization coverage rate of 69% in 2010 in Nigeria despite the poor knowledge on vaccines [25]. The acceptance of a vaccine may depend on factors that are numerous and more complex, than the level of vaccine knowledge by parents. The assumption that little knowledge about vaccines does not translate to refusal of vaccine may not be entirely applicable in a situation when a new vaccine is being introduced. However, poor knowledge may be responsible for spread of anti-vaccine rumors that result in waves of vaccine rejection. There was a low acceptability of IPV among parents. This is in contrast to the reports from the studies of other new vaccines [23,26]. Most parents have not heard of IPV and this may have contributed to their unwillingness to accept the new vaccine. Among the reasons some gave was concern about possible side effects. However when more information on IPV was made available to the parents, their acceptability significantly increased. Although in reality information alone may not be adequate to ensure the sustainability of acceptance of any new vaccine, the issue of cost is also to be considered. Nonetheless, doctors and nurses should provide parents with adequate information on both the benefits and risks of vaccines, in the effort to reduce the asymmetry of health information made available to parents in the health sector [27]. It is important that health workers are empowered with appropriate capacity to enable them educate mothers/caregivers, and every contact with parents provides opportunity for education. Vaccinators need to demonstrate positive attitudes toward the caregivers so as to encourage return visits for vaccine administration. The close interaction that existed in this study is not feasible o n a large scale during mass campaigns for a new vaccine. The only implementation mechanism that is capable of providing such close interaction in real life situation is if doctors and nurses in the course of discharging their daily activities will make out time to disseminate health related information. It is clear that if such is adopted, it will be sustainable in the long term, not only on vaccine related issues but also other misinformation that need to be correctly communicated. Unfortunately, several studies have revealed that healthcare providers, especially those practicing in sub-Saharan African countries, hardly give detailed explanation to the caregivers about their health conditions [27]. Therefore, to get healthcare providers to take up this task will require re-orientation exercise. Resources should be invested in improving the knowledge of vaccines by parents as it is believed that communication will promote informed and free will participation in immunization programs. The success of introducing a new vaccine will be more guaranteed if the dynamics of the socio-cultural relations of a given community is understood and incorporated in the program. More so when several studies have reported that the level of knowledge most parents have about childhood vaccination correlates with the family doctors and other healthcare providers they interact with [28–30]. This study also revealed that the perspective of parents is that the most reliable channels of communicating any new innovation in health care are through doctors and nurses. Thus, these cadres of healthcare providers should be urged to devote more time to creating awareness as they discharge their duties. The concerns most parents raised about IPV were pain at the injection site, abscess formation and paralysis of limb. The concern about pain from injection is common [31,32]. In our study most parents expressed concern about whether trained vaccinators would be used for IPV campaign. This specific concern was born out of

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experiences they had with other injectable vaccines and wished something could be done to improve on the service delivery. Studies in this part of the country showed that mothers preferred to go to fixed health facilities to receive vaccination rather than house to house campaign vaccines [33] and most mothers had generally good disposition toward vaccines in spite of possible adverse events [34]. With regards to pain management, the use of topical anesthetic cream such as Euthetic Mixture of Local Anesthetics Cream (EMLA) can effectively reduce the pain these children suffer due to injection [35–37]. However, several issues constitute major obstacles in the utilization of EMLA. Firstly is the issue of cost and consumers’ willingness to pay for the topical anesthetic cream and secondly is whether providers will be willing to use it due to prolonged onset of action time. Interestingly, a study done in this locality has shown that caregivers/parents of these children are willing to pay certain amount of money to prevent their children from suffering from preventable pains [38]. In a similar manner, it is not only that health care providers are very willing to adopt evidence-based strategies for management of injection related pain such as the use of topical anesthetic cream [39], it has also been found to be feasible to implement [40]. There were some important limitations in this study. First, respondents were all parents that brought their children for immunization at the immunization centre in tertiary hospitals, so the population was relatively homogenous, and may be different if primary health care facilities were included. Second, although this study was conducted in two tertiary hospitals, they are both located in the same geopolitical zone with likelihood of similar socioeconomic and cultural background. Thus any policy decision in other parts of the country may require prior studies on knowledge and attitudes. Third, the interviewer-administered method of the survey adopted in this study might have influenced the responses by parents especially with regards to acceptability after information. Another study limitation is not using a Likert scale score for the parents’ level of acceptability which other vaccine acceptability studies adopted [41,42].

5. Conclusion The knowledge of parents on vaccine was poor, as well as the acceptability of IPV (pre health education). However the acceptability of IPV improved with provision of knowledge on IPV. Despite the improved acceptability, most were concerned about injection associated pain and use of untrained health personnel to administer the vaccine. They recommended doctors, nurses, and representatives of Ministry of Health/National Primary Health Care Development Agency as most appropriate people to communicate the introduction of a new vaccine to the populace. In view of these, if IPV is to be introduced in Nigeria, as well as other sub-Saharan African countries, efforts should be made to channel the campaign through doctors and nurses at their service points. Furthermore, there will be increased IPV acceptability as well as other injectable vaccines if the parents’ fears about discomfort and pain can be reduced through the use of topical anesthetic creams and dangers of abscess reduced by vaccinator training and supervision.

Authors contributions Conception and design of the study: TBN, UMD and EDO. Data collection and analysis: UMD. Manuscript writing and review: UMD, TBN and EDO.

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Acknowledgement We are grateful to the parents of these children who gave their consent to be part of this study.

[21]

[22]

Appendix A. Supplementary data [23]

Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/10.1016/j.vaccine. 2014.08.053.

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