Evaluating the efficacy of a school-based hand hygiene programme for children in Malawi, sub-Saharan Africa : a cluster randomised controlled trial

Abstract

Background: Infectious diseases remain responsible for significant global morbidity and mortality. Communities continue to confront a serious threat from infectious diseases. This threat imposes a serious disease burden and has a tremendous impact on the healthcare system globally. Diarrhoea and respiratory infections are the two most common causes of mortality among children, especially in developing countries. The estimated deaths associated with acute respiratory infection and diarrhoea among children in resource-limited countries are 5.5 million. Nearly 2,195 children die of diarrhoea every day, more than from acquired immuno-deficiency syndrome, malaria and measles combined. Diarrhoea accounts for one in every nine-child deaths in the world, making it the second leading cause of death among children. Children in school settings are at a higher risk for infectious diseases because they spend most of their time in school, mix with other children, and get expose to many infections. In addition, they have poor hand hygiene practices. A hand hygiene programme including proper handwashing technique is the single most effective method of infection control. Hence, it is important to set up hand hygiene protocols and provide adequate handwashing facilities in schools through the whole-school approach of the health-promoting school framework. Schools are responsible for education; they do not expect to provide expert advice on prevention and management of infectious diseases, rather it is the role of healthcare professionals and local health authorities to develop hand hygiene protocols and deliver health education on the prevention and control of communicable diseases in schools. Effective and appropriate hand hygiene practice for primary school students is important in preventing diarrhoea and influenza, consequently leading to a reduction in school absenteeism. Efforts in promoting cognitive health through cognitive activities such as training and stimulation should start at an early age in order to maximise their cognitive function and overall health outcomes. Healthy living and lifestyle choices should introduce early in life. Research has shown that intellectual engagement and lifelong learning are associated with positive cognitive outcomes. Thus, it is important that healthy lifestyle behaviours such as proper handwashing technique should introduce in the early developmental stage to promote healthy lifestyle choices. This is possible to achieve in children because they have had less time to establish poor hygiene habits, unlike adults, whose habits are firmly grounded and difficult or unlikely to change. Hand hygiene, especially proper handwashing technique, is given little attention due to limited resources, especially in developing countries. As such, there is a lack of a structured school-based handwashing programme and available resources for children in primary schools in Malawi and other developing countries, especially in sub-Saharan Africa. Evidence of proper hand hygiene practice in schools in developing countries, including Malawi, remains scarce because very few evidence-based studies such as randomised controlled trials (RCT) conducted on hygiene among schoolchildren in developing countries. In addition, there is little evidence of a handwashing technique or procedure suitable for use by children in school settings to enhance the adoption of proper handwashing technique and compliance. A systematic review on hand hygiene intervention strategies to plan, implement and evaluate hand hygiene programme in developing countries identified that multilevel interventions were the most effective strategy to improve health outcomes. The components of multilevel interventions identified in this systematic review included formulating health policy/protocol, providing adequate training, creating supportive environments at different levels and ensuring resources availability by targeting different contextual levels, such as individual, group, community and organisation levels, to improve health outcomes. Thus, the researcher has adopted a multilevel interventions approach based on the concepts from the Bronfenbrenner ecological systems theory's five environmental systems (microsystem, mesosystem, exosystem, macrosystem and chronosystem). Bronfenbrenner's theory defines complex 'layer' of the environment and how each layer interacts with each other within the five systems. Thus, it is important to not only examine the child's immediate environment, but also at the interaction of the larger environment as each layer influences a child's own development (see figure below). Not only base on the concepts of Bronfenbrenner's theory as it aligns with the three focus areas of intervention in the whole-school approach of the World Health Organisation (WHO)'s Health-Promoting School (HPS) framework. Thus, the study conceptual framework is the theoretical guide of this study (see below figure). The three intervention areas of the HPS framework are 1) school curriculum, teaching and learning; 2) school ethos, environment and organization; and 3) school community partnerships and services. Aim: The aim of this study was to evaluate the efficacy of a school-based hand hygiene programme (SBHHP) using a multilevel interventions approach targeting schoolchildren, schools and their families in the intervention group versus the routine hand hygiene practice in the control group at four-time point (T0, T1, T2 & T3) for schoolchildren who participated in this study in Malawi, sub-Saharan Africa. Objectives and hypotheses: Primary outcome measure Objective 1: To appraise the impact of a SBHHP on schoolchildren's handwashing compliance (knowledge, skills and cleanliness) at four-time point. (i.e. knowledge refers to the scores of handwashing quiz; skills/technique refer to the scores of handwashing observational checklist; and hand cleanliness refers to the scores of the fluorescent stain test on both hands). Hypothesis 1.1: The group by time effect on knowledge score would be statistically significant after implementing SBHHP. Hypothesis 1.2: The group by time effect on technique score would be statistically significant after implementing SBHHP. Hypothesis 1.3: The group by time effect on hand cleanliness score would be statistically significant after implementing SBHHP. Hypothesis 1.4: The mean scores of handwashing quiz, the mean scores of observational checklists on proper handwashing technique and the hand cleanliness mean scores of the fluorescent stain test would be higher (better) after implemented the SBHHP using a multilevel interventions approach in the intervention group than in the control group at post-tests. Secondary outcome measures Objective 2: To assess the impact of the SBHHP on reducing children's sickness-related school absenteeism by evaluating the number of sick leave days. Hypothesis 2: The number of sick leave days would be lower after implemented the SBHHP using a multilevel interventions approach in the intervention group than in the control group at post-tests. Objective 3: To explore the acceptability of a multilevel interventions approach (i.e. formulating hand hygiene health policy/protocol, providing behavioural-change training on proper handwashing technique, creating supportive environments for schoolchildren at school and home settings, and ensuring the availability of physical and human resources to implement the programme) to plan and implement the SBHHP in primary schools in Malawi. Evaluation 3: To conduct focus group discussions with schoolchildren, school teachers, school principals and parents, to evaluate the acceptability (i.e. formulating hand hygiene health policy/protocol, providing training on proper handwashing technique, creating supportive environments and ensuring resources availability) of the planning and implementation of the SBHHP in primary schools in the communities of Mzuzu City, Malawi. Conceptual framework: Based on the review and concepts building from Bronfenbrenner's ecological systems theory and the interventions from HPS framework, a conceptual framework proposed for this study (see Figure 4). The theoretical foundation guiding this study are Bronfenbrenner's ecological system theory. The study of the children's environment conceptualizes from the ecological system theory. The ecological systems perspective or theory places emphasis on the interrelationships across levels of activity and includes not only the impact the individual has on his/her environment, but also the impact the environments have on the individual. In this study, the researcher adopted a multilevel interventions approach based on the concepts of the Bronfenbrenner's ecological systems theory that examines a child's development within the context of the systems environment and the relationships that form his or her surrounding environments, such as school environment, home environment and community environment. The researcher in this study planned and implemented hand hygiene programme by targeting more than one contextual factor that influence the schoolchildren's environments, including at the individual, group, community and organisational levels, to improve their health outcomes. This work included formulating the hand hygiene protocol, providing behaviour-change training on proper handwashing technique, creating a supportive school environment to practice the handwashing technique and ensuring the availability of handwashing resources, including adequate workforce, for planning and implementing the SBHHP for schoolchildren in participated primary schools in Malawi. The term multilevel interventions refer to those that affect at least two levels of influence for example, the child level, and the family level to improve health outcomes. An intervention is a specified strategy or set of strategies designed to change the knowledge, perceptions, skills, and behaviours of individual, groups or organization, with the goal to improve health outcome. The purpose of multilevel interventions is to affect the critical contextual issues and create a more efficient, effective, and coordinated public health care delivery system that achieves relevant patient outcomes, including improved hand hygiene care to prevent infectious outbreaks, to reduce school absenteeism and increase school attendance, to enhance health-related quality of life, at a reduced cost of all involved. In this study, the strategies of the multilevel interventions approach base on the findings of the researcher's systematic review conducted by Mbakaya and colleagues including policy development, behaviour-change training, supportive environments and resource availability. The researcher also examined beyond the individual's systems level for the planning and implementation of this SBHHP based on the concept of Bronfenrenner's social system theory and the three areas of intervention within the schools and outside the communities of the WHO's HPS framework. The three areas of intervention of the HPS framework are 1) school curriculum, teaching and learning, 2) school ethos, environment and organisation, and 3) school community partnership and services. Thus, the components of a multilevel interventions approach for the planning and implementation of the SBHHP consisted of development of hand hygiene protocol, integration of hand hygiene care into school curriculum targeted more than one contextual levels for example the children, families and community across the school systems level rather than one single level as described in the followings. In this hand hygiene study, the strategies to plan and implement the multilevel interventions targeting different levels of system in the child's environment. They were the integration of teaching and learning materials of hand hygiene programme into the school curriculum targeting schoolchildren and their families, formulation of hand hygiene protocol targeting school policy and community, creation of health promoting environment targeting children and their families, behaviour-change training on proper hand washing technique targeting individual child, peers and their families, development of stickers and posters of the simplified 5-step handwashing technique targeting children and families, make available handwashing resources in school and home settings, and partnership with health policy makers, community leaders and parents. The principles of the Bandura's social learning theory and Ajzen's theory of planned behaviour adopted to facilitate the schoolchildren's behaviour change inorder to promote proper handwashing technique. On the other hand, schoolchildren in the control group were encouraged to continue with their usual practice of handwashing, in which the WHO's 7-step handwashing technique was expected to be followed. The hand hygiene resources were given to control group. Methods: Study design A cluster randomised controlled trial (RCT) design adopted in this study. The study sample randomised into intervention and control groups. There were four-time points in this study: at the baseline (T0), at the 3rd month immediately after students participated in the SBHHP (T1), at the 6th month compliance evaluation (T2) and at the 9th month for sustainability testing (T3). Six focus group discussions with 37 participants, including parents, school staff, and primary school students were nested in a cluster RCT to enhance the quality of data and to explore the perception and the impact of the multilevel interventions approach targeting more than one level of system using strategies such as policy development, behaviour-change training, supportive environments and resource availability. The primary outcome measure of this study was the primary school students' compliance with proper handwashing technique (knowledge, skill and cleanliness), and the secondary outcome measures were the reduction in the school absenteeism (sick leave days) and the acceptability of the implementation of the SBHHP using a multilevel interventions approach. Sampling and Setting: Six schools were randomly selected and allocated to intervention (3 schools) or control (3 schools), with 375 schoolchildren. All eligible schools (12) were included in the randomisation process for selection using an online randomisation process to generate a randomisation plan. An independent person came up with sequentially numbered, opaque, sealed envelopes (SNOSE) for allocation concealment. Malawi's population estimated at 19,107,706 people. Mzuzu locates in the northern region of Malawi. It is the third largest city in Malawi, with a total area of 26,931 square kilometres and a total population of 175,345 people. The city has 55 elementary/primary schools, of which 41 are government owned and 14 are private schools. This study took place in six private primary schools in Mzuzu from September 2016 to July 2017. Private primary schools have better hygiene and sanitation facilities compared to government primary schools in the city in terms of toilet facilities, water facilities, rubbish disposal around the school and the bodily hygiene of students. Study instruments: The first of the six study instruments used the demographic sheet, which was used to collect information on the age, class, gender, and location of schools. Second, the handwashing quiz used to collect information on students' knowledge regarding handwashing. Third, the observational checklist used to monitor the schoolchildren's competency in adoption of the simplified 5-step handwashing technique. The fourth study instrument used the fluorescent stain test, which was used to check the schoolchildren's compliance in terms of the cleanliness of the hands, with four rating scores. The fifth study instrument was the sick leave record form, which was used to collect data on students' sick leave day. Lastly, the guide of focus group discussion developed from the literature review used to collect qualitative data to enhance the quality of study data. Data Analysis: IBM's SPSS statistics 23 software used to analyse the data. The principles of intention to treat (ITT) was applied. Little's MCAR test was insignificant (chi square = 201.44, df = 381, p > .05). The hierarchical structure of the original data considered when analysing the data, and the multilevel model was used to analyse the effects of each level such as school and students. A generalised linear mixed model (GLMM) used to model the fixed effects of time, group, grade, and their interaction with time; the residual effects across time; and the random effects of the intercepts of the schools on target variables, including knowledge score, technique score and hand cleanliness. The random effect was the intercepts of the schools. The significance level (alpha) was set at .05. No assumptions (homoscedasticity, normality and linearity) violated. Absence records for a full academic year (2016/2017) extracted from the school attendance register and used as input data. Generalised estimating equations (GEE) used to analyse number of sick leave days between groups across school terms. Finally, thematic analysis used to analyse the data obtained through focus group discussion on the acceptability of the multilevel interventions approach of the SBHHP focusing on the implementation of the hand hygiene protocol, training in the handwashing technique, and the availability of hand hygiene resources. Meanings coded, and themes were emerged to ensure that the formulated meaning accurately reflected their true intention. Two coders, the researcher and another doctoral student, identified themes independently and compared codes, and a third person (another doctoral student) resolved any differences raised by the two coders to ensure rigour. Results: The study findings show that implementation of the SBHHP using multilevel interventions approach had a significant impact on hand hygiene compliance and its sustainability among primary school students in the intervention group. There was a statistically significant improvement in the handwashing quiz scores (knowledge) in the intervention group compared to the control group (p<0.05) at the 3rd month immediately after students participated in the SBHHP (T1), at the 6th month for compliance evaluation (T2) and at the 9th month for sustainability testing (T3). Compared with the control group, the intervention group had better knowledge scores (B=1.97, 95% CI [1.16, 2.79], p <.001). In addition, there was a statistically significant improvement in the handwashing observational checklist (technique score) in the intervention group compared to the control group (p<0.05) at the 3rd month immediately after students participated in the SBHHP (T1), at the 6th month for compliance evaluation (T2) and at the 9th month for sustainability testing (T3). The intervention group achieved better 5-step technique scores than the control group (B=5.14, 95%CI [4.48, 5.54], p <.001). In terms of their fluorescent stain score (hand cleanliness), the improvement was statistically significant at the 6th month for compliance evaluation (T2) and at the 9th month for sustainability testing (T3) (p<0.05). Compared with the control group, the intervention group was associated with better hand cleanliness scores (OR=21.51, 95%CI [4.38, 105.72], p <.001). Compared with the 3rd term/semester, the 1st term/semester was significantly associated with higher number of sick leave days (B=8.417, 95%CI [.948, 15.885], p=.027). At baseline, the number of sick leave days was lower in control group, but the number decreased across time in the intervention group. The synthesis of the themes and sub-themes from the focus group discussions indicates that implementation of the SBHHP using a multilevel interventions approach had high acceptability and potential for sustainability of proper handwashing technique among primary school students in the school communities in Malawi. Discussion: The results of the SBHHP show significant effect on the study outcomes at different contextual levels such as organisation (resource mobilisation, hand hygiene protocol, training), community (community/family linkage, supportive environment), group (group and social influence) individual level (improved hand hygiene compliance, reduced sick leave days). The SBHHP based on the concepts of Bronfenbrenner's social systems theory, a socioecological model for understanding the multilevel contributors to improve schoolchildren's ecological outcomes. This model recognises the importance of policy, environment and social influences on population level that is much greater than that of individually targeted interventions. For example, study findings in Finland reported that tobacco use declined over ten years after launched a community-wide multilevel intervention to reduce cardiovascular diseases. Overall, the study findings show that implementation of a SBHHP had significant effects on schoolchildren's handwashing compliance, including increased scores in knowledge (p <.001), handwashing technique (p <.001) and hand cleanliness (p <.001). There was also a significant decrease in the number of school absenteeism days across time in the intervention group (p=.027). The results of this study also agree with similar studies conducted previously in other countries like Netherlands, Thailand and Hong Kong in different contextual levels. For the organization level, the outcome of the SBHHP was evident through incorporating the hand hygiene protocol into the school curriculum, hand hygiene resource mobilization, and training. Incorporating hand hygiene protocol into the school curriculum, which is in line with the WHO's HPS framework is a significant step in achieving and scaling up the implementation of SBHHP in Malawi and other developing countries. The study findings are similar to a study conducted by Lee and colleagues in Hong Kong. They found that students in the Hong Kong Healthy Schools Award (HSA) scheme were better in hygiene practice, knowledge on health and hygiene, as well as access to health information. HSA schools reported to have better school health policy, higher degrees of community participation, and better hygienic environment. For the individual outcome of the SBHHP upheld in the intervention group at the 9th month follow-up assessment for sustainability testing (T3) on hand hygiene compliance and reduced school absenteeism (sick leave days). The study findings are similar to a study conducted by Lee and her colleagues, as they found that intervention group experienced a significant increase in the rating of their handwashing quality. The intervention school also experienced a significantly lower absenteeism rate than the control group in the same academic year. For the family level, the SBHHP had an effect on creating a linkage with the family members. Results from focus group discussion show that parents provided hand hygiene resources for their children. The family also provided a supportive environment for their child to continue with hand hygiene practice. In the current study (SBHHP), the researcher linked the student's family through leaflet containing information on when, why and how to wash hands (take home package). Parents also participated in the focus group discussion. The study findings are similar to a study conducted in Appalachian Ohio on the uptake of human papilloma virus (HPV) vaccine by Paskett and colleagues. Participants in the intervention group received a take home package on HPV information. The comparison group received influenza vaccine information sheets. They found that by six months, more daughters of intervention participants received the first HPV vaccine shot compared to daughters of comparison group participants. This is a significant indicator for behavioural change and compliance with proper handwashing technique among schoolchildren regarding hand hygiene practice. The findings of this trial also suggest that using simple techniques such as the simplified 5-step technique for washing hands, as well as the provision of expert advice and necessary resources in schools could improve the adoption/practice of and compliance with proper handwashing technique. The SBHHP has potential to implement in Malawi, because the primary school students, staff and parents, as evidenced by quantifiable results and verbatim quotes in the data from the focus group discussions have already accepted it. The new knowledge generated by this study relates to the application of multilevel interventions approach based on Bronfenbrenner's ecological systems theory to examine the five layers of environmental influences on schoolchildren in planning and implementing a SBHHP. Each layer interacts with the others. To study a child's development in Bronfenbrenner's ecological systems theory, it is important to examine not only the child and his or her immediate environment, but also the interaction of the larger environment as well. This aligns with the three areas of intervention of the WHO's whole-school approach in the HPS framework. The study limitations were the observational bias (Hawthorne effect), which may have resulted in increased proper handwashing, including skill display, because participants knew that they were being observed through photographic and video capturing. The study population included only schoolchildren from private schools in the developing countries, thus the generalisation of the study findings is limited. Single-blinded assessor was used to score the 5-step handwashing technique (skill acquisition) of schoolchildren. As such, no inter-rater correlation for reliability analysis was calculated. Conclusion: The implementation of the SBHHP adopts the multilevel interventions approach based on the concepts of the Bronfenbrenner's environments theory, which aligns with the three areas of intervention of the WHO's whole-school of HPS framework. This is an effective strategy in improving hand hygiene compliance, school attendance and reducing school absenteeism (sick leave days) among schoolchildren. The results of this study suggest that the planning and implementation of a SBHHP targeting the schoolchildren, family, community groups and school and government organisations have shown evidence of improved study outcomes at different contextual levels such as organisation (resource mobilisation, hand hygiene protocol, training), community (community/family linkage, supportive environment), group (group and social influence) individual level (improved hand hygiene compliance, reduced sick leave days). The results of this study show that the strategies to implement SBHHP using a multilevel interventions approach including the partnership between education and school sectors to plan and formulate the hand hygiene protocol and provide behavioural-change training on proper handwashing technique in a supportive school environment that is essential for the implementation of SBHHP. It is the most effective interventional strategy to go beyond the individual to promote and sustain schoolchildren's competency and compliance in performing proper handwashing technique in schools, especially in developing countries. Adopting a multilevel interventions approach in this study has provided an impetus for health promotion campaigns target beyond the individual's environment such as assessing the schoolchildren's surrounding by various environments in the system level targeting specific groups to improve their health outcomes after behavioural change. The design and implementation of SBHHP using multilevel interventions facilitated by input from the school community. Research findings support that it is useful to assess and evaluate the impact of interventions at multiple levels, rather than using a single-level intervention to improve population health outcomes. More advanced study methods and measure need to evaluate the impact of the various levels and components of such interventions.