Assessment of attitudes and practices influencing adherence to seasonal malaria chemoprevention (SMC) in children &gt;5 years of age: The case of Rural Embangweni Mzimba district, Malawi.

doi:10.21203/rs.3.rs-2863116/v1

Background: In the Sub-Saharan region, where malaria transmission is mainly seasonal, seasonal malaria chemoprevention (SMC) is the intermittent administration of a 3-day course of anti-malarial drugs during the months of maximum malaria risk. SMC is a useful intervention for lowering the frequency of simple and severe malaria episodes in children. However, morbidity cannot be decreased without treatment adherence. This study examined SMC medication adherence to understand caregiver attitudes and behaviours throughout the 2021 SMC campaign in rural Embangweni.

Methods: This study was carried out based on information gathered through random cluster sampling during independent monitoring. Adherent levels and caregiver attitudes and behaviours were assessed using information from caregiver self-reports and taxonomically analysable data.

Results:90.7% of caregivers (N = 300) knew that the medications help prevent malaria, and at the start of the treatment period, 90.7% of children (N = 300) received their first medication delivery. However, only 67% of caregivers (N = 200) stated that HSA was present when the treatment was initiated. 90% of kids (N = 300) and 81% (N = 219) of kids at the start of the treatment phase took their medication on the second and third days, respectively. The three primary excuses caretakers cited for stopping the three-day course of medication were "forgetting," "not having time," and "the mother's absence."

Conclusion: This quick, low-cost study showed that SMC coverage and caregiver adherence to complete the entire 3-day drug course were both high. The poll also revealed that some caregivers' understanding, attitudes, and practices surrounding medication adherence during the SMC campaign might be improved. Even greater adherence might result from enhancing training for distributors, developing and supplying them with tools for interpersonal communication, and tightening oversight.

Seasonal malaria chemoprevention

Adherence

Attitudes

Practices

HSA

Caregivers

In Malawi, malaria is a significant public health issue. This illness is a significant global cause of morbidity and mortality, with an anticipated 241 million new cases and 627,000 deaths in 2021 (WHO, 2022). The African area of the World Health Organization (WHO) is the most severely affected, accounting for 95% of all cases and 96 % of all deaths worldwide, with 77% of all malaria deaths occurring in children under the age of 5 (Molyneux et al., 1989; WHO, 2022). With the 7th greatest number of cases and the 8th highest number of malaria deaths worldwide, Malawi is one of the ten worst-affected nations. Children under the age of five in Malawi are most likely to contract malaria, with 296 cases per 1000 people. In the Sub-Saharan region, where malaria transmission is primarily seasonal, the WHO suggested seasonal malaria chemoprevention (SMC) for the management of malaria in children under 5 years of age (WHO, 2013). To prevent malarial illness and death, SMC entails the intermittent administration of a 3-day course of antimalarial drugs during the months with the highest malaria risk. Sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ), each given as a separate pill on days 1, 2, and 3 of each 3-day course in rural areas of Embangweni, namely Mabiri, Kalikumbi and Mharaunda were administered on the first day of each course. Each child aged 3 to 59 months in a certain household on that day in 2021 received this blister pack of four pills (1 SP and 3 AQ) from Community Health Workers (CHW) known as Health Surveillance Assistants (HAS), regardless of whether they reside there year-round or are only visiting for the holidays. Between July and October 2021, four of these 3-day courses were offered at 28-day intervals. There is documented evidence of SMC's impact at scale under programmatic conditions, and the WHO recognizes it as an effective intervention to reduce bouts of simple and severe malaria in children by about 75%. The community distributors in this case HSA and caregivers must follow the procedure to achieve this reduction in morbidity (Sottas et al., 2019).

It should be noted that international and national protocols for SMC were amended to include COVID-19 adaptations after COVID-19 spread internationally in early 2020 (WHO, 2013). This was done to stop the SMC campaigns from turning into super-spreader events. Instead of asking HSA to give the drugs to the caretakers and advise them to immediately give one SP and one AQ pill to each kid, as they had in previous years, they were instructed to do so to allow for direct observation while maintaining social distance. As in past years, caregivers would provide the second and third AQ pills on consecutive days, ideally at the same time of day, unattended by an HSA. The process by which people take their medications as recommended by a healthcare professional is known as adherence to a medication regimen. The concept of adherence has been further developed by some researchers to incorporate information on taking the recommended dosage of tablets each day and doing so within the recommended window of time. Poor attendance during SMC campaigns may result in less-than-ideal kid protection. Adherence during SMC is influenced by a variety of variables, including distributor, mobility- and patient-related variables as well as the patient's relationship with HSAs. When HSAs fail to adequately explain how to administer medication, as well as the advantages and potential side effects, and fail to take into account the living circumstances of caregivers (such as the absence of clean water in the home) during health education sessions, these latter factors can contribute to poor adherence. Medication adherence during SMC has been linked to social support networks, such as friends and neighbours, that assist allay caregiver worries and foster belief in the efficacy of medications. Previous campaign experience has also been found to be playing a bigger role in acceptance and adherence.

Despite the vast amount of literature on drug adherence, a "gold standard" for determining adherence has not been established. Direct and indirect approaches can be used to categorize the available options. The administration of medications while being closely watched, the measurement of drug or metabolite concentrations in the blood or urine, and the detection or measurement of a biological marker for the drug in the blood are a few examples of direct approaches for gauging adherence. Direct methods are pricy, difficult and susceptible to patient bias. However, monitoring these levels is an effective, widely accepted technique to assess adherence to particular drugs. The patient is questioned about how easy it is to take the prescribed medications, clinical response is assessed, tablets are counted, patient questionnaires are collected, electronic drug monitors are used in all facilities associated with the SMC initiative, physiological markers are measured, and the patient is asked to keep a medication diary, and children's adherence is assessed by asking a caregiver for assistance. This final method was employed during an independent monitoring survey carried out in conjunction with HSA during SMC to assess child patient adherence in Mabiri, Kalikumbi and Mharaunda.

Through the Department of Health Management Information System (HMIS) it was decided to re-examine the data from the independent monitoring of the 2021 SMC campaign using cross-sectional analysis. Through this analysis, it was noted that adherence is built on three components. The process through which patients take their prescriptions as directed is known as "adherence to medications" in the first category. There are three parts to adhering: starting, doing, and stopping. The process by which healthcare institutions, clinicians, patients, and their social networks monitor and encourage patients' adherence to drugs is called "management of adherence" and is the second component of the taxonomy. "Sciences associated with adherence" make up the third component. This component encompasses the academic fields that aim to comprehend the reasons behind or effects of discrepancies between prescribed and real medication exposures. The study hypothesised that SMC drug adherence in Mzimba might be problematic. Discrepancies between the recommended/expected behaviours and those used by HSA (e.g., not directly observing the administration on the first day, but leaving the blister pack with caregivers with instructions to administer the pills later, if the child is absent at that time) and caregivers were noticed during campaign supervision missions in Mabiri (e.g., not going to a health centre to get an additional pill if the child vomits or spits out the medication on day 2 or 3). Recent studies demonstrated low drug levels in the blood of children despite caregivers stating that they had given the second and third AQ pills, even though adherence to SMC treatment has been reported to be extremely high in other Sahel regions where Malaria is also seasonal (Koko et al., 2022). It should be highlighted that factors other than non-adherence, such as ineffective dosing, poor absorption, and quick metabolism, can contribute to low medication levels.

This study set out to determine the attitudes and behaviours of caregivers regarding the administration of AQ on the second and third days, estimate adherence to anti-malarial medication in children aged 3 to 59 months during the 2021 SMC campaign in rural areas of Embangweni namely Mabiri, Kalikumbi and Mharaunda, and suggest corrective actions to improve adherence during the campaigns. To achieve the study's goals, the team used randomized cluster sampling to conduct a secondary analysis on household surveys that were carried out across the campaign's 3 cycles (Creswell, 2014).

Data gathered through the administering of questionnaires and unbiased observation of the 2021 SMC campaign in Mabiri, Kalikumbi and Mharaunda rural areas were used to perform this study (Oppenheim, 1992). Monitoring is a process done separately from campaign execution to determine the intervention's household coverage, which was done by a lead researcher with the assistance of enumerators mainly senior HSAs within Mabiri, Kalikumbi and Mharaunda health centres under Synod of Livingstonia Health Department.

Study Setting

Malaria is the main cause of health problems in Mzimba (Socio-Economic Profile, 2017). The incidence is increasing annually despite a wide range of interventions. It is followed by pneumonia and diarrhoea, and their incidence is also increasing. These diseases contribute to high infant and under-five mortality rates (Socio-Economic Profile, 2017). In Mzimba district, specifically Mabiri, Kalikumbi and Mharaunda, malaria continues to play a substantial role in child mortality. With an annual illness incidence ranging between 230 and 300 cases per 1000 people, the 3 synod health centres that make up the health region are all situated in the moderate transmission area or short seasonal transmission area (less than 3 months) (Socio-Economic Profile, 2017). Malaria is still the most common cause of hospital visits and the main cause of death in Mzimba, accounting for 167,822 cases (Socio-Economic Profile, 2017). In 2016, the mortality rate from malaria in children under the age of five was 52%. Mzimba district has been running annual SMC campaigns since 2013. From the main health facilities in 2013 to all health facilities including health centres under the Christian Health Association of Malawi (CHAM) 2020, the implementation has grown. The target population for the intervention in 2021 was 23,000 children aged 3-59 months. Nearly 80% of the kids in the intervention districts have received SMC since 2013 when the intervention program began. Malaria incidence in health centres, however, continued to be high. As a result, concerns were expressed over the effectiveness of SMC in the area. It was proposed as a potential reason for the persistently high prevalence of malaria because of the caregivers' poor adherence to the entire 3-day course of drugs.

Table 1: Trends in morbidity.

Cases / Period	2013	2014	2015	2016
Malaria	83,236	106,587	114,288	167,822
Pneumonia	18,139	19,648	16,845	13,592
Diarrhoea	11,617	13,142	11,537	12,838
Oral Condition	21,568	21,995	21,447	21,706
Skin Infection	14,070	19,621	19,944	19,458
Eye Infection	7,398	8,027	7,117	7,034
STI	5,610	6,173	8,215	9,705
Wounds	15,799	14,261	15,110	12,838
Ear Infections	2,745	3,127	4,023	4,859
Dysentery	2,253	4,178	3,620	2,972
Malnutrition	1,156	1,434	1,839	3,431
Syphilis in Pregnancy	23	44	18	60

Source: SEP, 2017.

Table 2: Mortality trends.

Child Mortality Indicators	2000	2004	2008	2010	2016
Under-five mortality / 1,000 live births	189	133	124	110	52
Infant Mortality / 1,000 live births	104	76	78	85	31
Neonatal Mortality / 1,000 live births	42	27		49	15
Child Mortality / 1,000 live births	95	62		50	22

Source: SEP, 2017.

Study Design and Study Population

Study population

Caregivers of children aged 3–59 months in Mabiri, Kalikumbi and Mharaunda were approached and asked to complete the survey.
Choice of sample

During each cycle of the 2021 SMC campaign in Embangweni, 3 health centres was the focus of the independent monitoring, totalling 6 HC for the 3 rounds. Three health areas were chosen at random from a list of the district's health areas (Tabachnick and Fidell, 2001). 8 localities were chosen at random from the list of localities (villages/neighbourhoods) under each health centre to be surveyed. By visiting every other family compound in a locality, 60 family compounds were randomly chosen (note that a family compound includes more than a nuclear family, for example, it can include grandparents, multiple sons with multiple wives and their children, nephews, and younger siblings of spouses). The parents of all eligible youngsters in each chosen family complex were methodically questioned. The surveys ran for three days, beginning on the second day of each cycle. This meant that only questions concerning day 1 could be asked if a child received the first dose on day 3 of the distribution period and researchers visited on that day. Independent monitors went to the family compounds, located the kids who qualified, questioned the parents about the current cycle, and checked that the SMC cards were correctly filled out. In the 8 localities of Mabiri, Kalikumbi and Mharaunda, 8 localities (villages/neighbourhoods) and 60 family compounds were observed during the course of the 3 cycles. During the campaign, each health centre and locality were only observed once; hence, the homes visited after cycle 3 were distinct from those seen after cycle 1. Additionally, the homes that were visited on day 3 were distinct from those that were visited on day 2 of a single cycle. Interviews were conducted with the carers rather than the younger children.

During a single survey, a caregiver could provide information regarding multiple children. No data on the caregiver's age or gender was gathered because this was a program monitoring effort rather than a research project.

The child's sex and general age range (3-11 months and 12-59 months) were gathered. A systematic questionnaire with pre-established response categories was used. The long-used survey instrument in Zambia served as a major inspiration for the creation of the tool. Before being used in the field, it was digitalized in SurveyCTO and evaluated (Pandey. P and Pandey. M, 2018). To prevent the same persons who were distributing or overseeing the distributors from judging their job, the survey monitors were independent of the SMC campaign and were chosen from outside the health sector/health centres involved.

Data Collection

Data Analysis

The project team used cross-sectional and Professor Bernard Vrijens' taxonomy's initial component to analyse the data (Koko et al., 2022). The benefit of this strategy is that it breaks down the adherence process into steps, making it easier to analyse any differences that can affect the intervention. Different levels of adherence may exist during the "adherence to drugs" phase:

At the beginning of therapy, for instance, the child may refuse to drink the medication or spit it out or vomit it up, or the medication may not be given under the distributor's direct view.
When a treatment plan is being implemented, caregivers may forget to deliver medication on future days, fail to give medication by the dosage, or simply opt not to give medication for another reason (for example, after minor or major side effects occur or the child refuses to consume the other doses).

The first, second, and third days of the three-day course's medication compliance, as well as an assessment of the caregivers' attitudes and behaviours, served as the indicators for the analysis.

An explanation of the indicators:

% of target children who received the SP and AQ: the proportion of eligible children who received medication on the first day of the three-day treatment.
% of the SP administration observed but not administered by the drug distributor: the proportion of eligible children who got medication on the first day of the three-day course while being directly observed.
% of target children who received medication on day 2 of the three-day treatment, as measured by the proportion of eligible children observed who received medication on that day.
% of target children who received medicine on day three of the three-day treatment: the proportion of eligible children who received medication on day three of the three-day course.

Take note that the direct observation question was split into two parts: If the youngster received treatment, who gave the initial dose? In a drop-down box, the surveyor was asked to choose between caregiver and HSA. If the response to the first query was caregiver, the next query would appear: Was the HSA present when the caregiver administered the medication, if so?

A caregiver could be a parent, grandparent, aunt, older sibling, mother, father, other relative, or even a neighbour. Regardless of their relationship to the child, 90.7% of caregivers who were polled knew that the SMC drugs were intended to treat paediatric malaria (the survey's "Against which disease have your children have been treated?" question). beginning of the treatment (taking the first dose of the drug) During the independent monitoring, 15,000 kids in Mabiri, Kalikumbi and Mharaunda had their SMC treatment started by the distributors evaluated. The proportion of children who received their first dose of medication was, by the caregiver's declaration, 90.7% (n=300) during the first cycle and remained constant at 90.0% for the following cycles. When the monitors confirmed that the SMC card was marked, the team noticed identical patterns. 67% (n=200) of the caregivers polled claimed that HSA were present when the first day of treatment was initiated.

There is an upward trend Putting into practice the dosing schedule (taking the drug on the second and third days of the three-day treatment) On the second and third days of the three-day course, the medication compliance of a total of 15,000 kids was assessed. The caregivers reported that of the children who attended the three-day session, 90% (n= 300) took the AQ on the second day and 81% (n= 219) took it on the third day. In comparison to later cycles, adherence to the drugs on the second and third days was poorer in the first cycle. 7.3% (446/6111) of the children who were monitored for adverse drug reactions (ADR) reported just minor ADRs.

Vomiting (26.7%), tiredness (22.6%), diarrhoea (13.2%), and appetite loss were the most common ADRs (12.0%). Itching (4.5%), fever (5.5%), stomach discomfort (4.9%), and rash were some of the ADRs that were less frequently reported (4.8%). the cessation of treatment Only 122 caregivers (12%) of the total 300 interrupted their child's treatment. 37% of respondents said they forgot, 31% said they ran out of time, and 14% said they were absent.

Table 3: Trends in morbidity.

Source: Author.

Table 4: Trends in morbidity.

Source: Author.

Table 5: Trends in morbidity.

Source: Author.

If the drugs are taken as prescribed, SMC during the peak transmission season prevents a significant number of clinical bouts of malaria in children. Therefore, one of the most important factors in determining the success of the treatment is adherence to SMC drugs. The development of medication resistance may also be facilitated by non-adherence (Pell et al., 2010). We were able to determine various levels of adherence through the analysis of the data from Mabiri, Kalikumbi and Mharaunda. The fact that 90.7% of kids received their first dose of SP and AQ at the start of the therapy comforted us about the target population's coverage of SMC and the caregivers' willingness to accept the medication. The reported levels of coverage in this study were quite comparable to those discovered in several sub-Saharan African investigations. Given that caregivers are aware of SMC as a malaria intervention and that SMC has been shown to improve the health of children treated during prior campaigns, the high coverage may be a sign of strong acceptance. The high acceptance of the intervention suggests that some or all of these aspects may have been the result of good adherence to the entire 3-day course seen in this study. Strong information or favourable experiences may not be necessary, according to ACCESS-SMC (2020). The study, as moms will adhere nonetheless. Even when a patient or caregiver is "conscious of the risk" and motivated by the child's wellbeing, making decisions about treatment adherence can be challenging and complex.

The decision-making process is likely to be influenced by values such as the carers' priorities (work or the child's well-being), life philosophy (treat to protect), perception of their effectiveness (capacity), and history (malaria is a risk for everyone) (Lee et al., 2013). This implies that even while the program is well received, distributors should continue to follow the dose instructions and use contact with caregivers to educate caregivers about adherence to the prescriptions on following days, potential adverse events, and what to do in their presence (Diawara et al., 2017). Our findings, however, indicate that just 67% of caregivers claim that the first dose was started while HSA was present. This suggests that the HSA may have left the entire blister pack in the home with instructions for someone to administer the pills later (Camara et al., 2019). Zambia and Mozambique both had the same customs and results in one of the studies done by Barry et al., (2018). HSA attributed this mismatch to a lack of time to revisit the household later in the day to check if they could arrive while the child was home due to an overwhelming workload, in the qualitative study by Faye et al. and numerous studies show that when the initial dose is immediately viewed by HSA and when the caregivers are given complete and correct information, they are more likely to stick to anti-malarial therapy (Sangare et al., 2012). HSA training could be increased by simulating typical caregiver encounters to combat caregivers' incomplete knowledge. HSA could therefore gain from using interpersonal communication technologies to enhance house visits (memory aids, flipcharts with images). Finally, monitoring the campaign may involve watching HSA interact with caregivers and using a checklist to determine whether key messages were conveyed.

According to the carers' statements, the results also demonstrated that adherence levels were high at the implementation stage of the dosage regimen: 90% of children took their second dose of medication and 81% took their third dose. The findings support those made in studies by Koko et al., (2022) in Niger, which assessed adherence based on caregivers' statements. The fact that the SMC drugs were well tolerated may be the cause of these levels of adherence in Mabiri, Kalikumbi and Mharaunda. Only a few minor adverse medication reactions, including vomiting (26.7%), tiredness (22.6%), diarrhoea (13.2%), and appetite loss, were reported by the caretakers (6.8% of the children among those being watched) (12.0%). Adherence is also influenced favourably by other elements, including the health education caregivers received throughout the campaign, the kids' perceptions of the advantages of prior doses, and the patient-provider connection. These specifics highlight the need to supply encouraging and motivating information and the medication that supports the carers' positive attitudes and behaviours. Only 122 caregivers (12%) of the total 300 interrupted their child's treatment. The primary explanations given by caretakers for why the SMC treatment was stopped in Mabiri, Kalikumbi and Mharaunda were "forgetting" (37%), "not having time 31%," and "the mother's absence 14%." Farmers make up the majority of the population in the study area, and because of the demands of their labour in the fields at that time, many of them may forget to take their medics or may not be at home when it is time. The necessity to design behavioural interventions or a mix of behavioural interventions is suggested by this observation to increase the carers' adherence on subsequent days at home. Other family members, neighbours, and other forms of social support, like community outreach, could be involved in these interventions to increase children’s timely and adequate dosage.

Limitations:

Selection and observation bias is inevitable in any observational study. Participants surveyed during the monitoring were chosen at random to reduce these biases. The data was gathered from people who were not involved in the SMC campaign's implementation and who were not aware of the study's purpose or topic. A few things need to be taken into account while interpreting the results. First, several biases can affect the adherence evaluation method of self-reporting, including memory bias and social desirability bias. Data collection took place during the campaign's execution, or no later than one to three days after the first dose of medication, so order to eliminate memory bias. SMC cards and bare blister packs were also examined to combat the social desirability bias. Second, this study was carried out in Mzimba district, which is primarily made up of rural areas with a mixed malaria load. Therefore, the findings can be applied to other places with the same profile. They might, however, be less applicable in metropolitan settings where caregivers have diverse lives.

In Embangweni Mzimba district in the areas of Mabiri, Kalikumbi and Mharaunda, during the 2021 SMC campaign, this study evaluated the attitudes and behaviours that affected children 3-59 months of age's adherence to anti-malarial therapy. According to the study, adherence levels peaked at the beginning of each three-day course with a slight decline on the second and third days. The caregivers' acceptance of the prescriptions and the SMC medications' good tolerability are the key attitudes and behaviours that influence high levels of adherence, whereas "forgetting," "not having time," and "the mother's absence" were the factors that contributed most to non-adherence. HSA as community health workers should continue to monitor the first dose's administration despite the caregivers' acceptance of SMC and take advantage of this face-to-face time to improve the caregivers' knowledge of medication adherence on subsequent days, potential adverse drug reactions, and what to do if they happen. This study shows that before implementing measures to enhance full adherence, like three-day directly monitored therapy, malaria programs should carefully consider the possible benefit and costs based on the data. The results of the study do not indicate that there is a significant issue with adherence.

Author Contributions:

Chisomo Salangwa. Conceptualization, data curation, formal analysis, methodology, software, validation, visualization, writing—original draft.

Dunny Lusale. Writing—review & editing.

Funding:

This research was conducted under Synod of Livingstonia Health Department Monitoring and Evaluation unrestricted funds, which are mainstreamed in the monitoring of facilities. The data collection, analysis, interpretation, and writing of the manuscript were conducted independently by the author.

Institutional Review Board Statement:

The animal study protocol was approved by the Institutional Review Board (or Ethics Committee) of Copperbelt University under the postgraduate Public Health Research Committee.

Informed Consent Statement:

Informed consent was obtained from all participants and caregivers involved in the study.

Data Availability Statement:

The data presented in this study are available on request from the author. The data are not publicly available due to privacy and confidentiality.

Acknowledgments:

I would especially want to thank Copperbelt University, the Synod of Livingstonia, and the MoH for their methodological advice and leadership support during the execution of this study. I also want to express my gratitude to all the HSAs, clinical officers, and caregivers who took part in this study.

Conflicts of Interest:

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analysis, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

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No competing interests reported.

Assessment of attitudes and practices influencing adherence to seasonal malaria chemoprevention (SMC) in children >5 years of age: The case of Rural Embangweni Mzimba district, Malawi.

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Abstract

Introduction

Materials And Methods

Results

Discussion

Conclusion

Declarations

References

Additional Declarations

Status:

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