The results are presented in two parts. The first part is the exploration of the knowledge of caregivers about malaria, the prevailing treatment seeking behaviour in the community prior to the intervention and the participants' involvement in determining the intervention activities. The second part reported findings at assessment of intervention one year after distribution of AL.
Knowledge and Recognition of Malaria in Children
An important exploratory study was conducted at the beginning of the FGDs to ascertain the study communities' definition and nomenclature for malaria. The locally recognized syndromes in children treated with antimalarial drugs by participants and the local terminology 'iba' were explored. Most of the FGD participants described "iba"- the local terminology for fever as high temperature associated with chills/rigors, vomiting, anorexia, headache and weakness. This definition is consistent with the symptomatology of malaria as seen in clinical practice. The FGD participants also mentioned that "iba" when literarily translated means fever, "iba" is as such also used for other febrile illnesses not presumed to be malaria. However, if a febrile illness is perceived to be from another cause the "iba" terminology is further qualified. Examples given by FGD participants are: a febrile illness perceived to be caused by measles, is called "iba ogbele". "Ogbele" is the Yoruba word for measles and "iba typhoid" if the fever is perceived to be due to typhoid fever. This preliminary finding was useful in ensuring that researchers and community members were in agreement in the use of the terminology for malaria.
Malaria in children was perceived to be a serious problem in the community and the general consensus among the participants was that it kills children fast if care is not sought promptly. A young mother said: "malaria is a major health problem because if it stays too long in a child's body, it drains the blood".
The participants demonstrated good knowledge of the symptoms and signs of malaria. The symptoms and signs participants associated with uncomplicated malaria included fever, chills, excessive weakness, anorexia, vomiting, excessive sleep, 'stretching of the body', concentrated urine, headache and dull looking eyes. For severe malaria, they mentioned very high fever, convulsion/fits, restlessness, prostration, excessive vomiting and weakness, yellow eyes and dark coloured urine. Some respondents mentioned they suspect severe malaria when a febrile child is not responding to the treatment first given.
Treatment practices
The prevailing treatment practice for malaria in children at onset of this study was the use of orthodox drugs bought from patent medicine sellers (PMS) or drug hawkers and the use of local herbs at home. The option first explored depended on availability. Commonly, herbs were mentioned to be readily available hence are used first in many instances. This is usually followed by orthodox drugs if available soon after in addition to the herbs already given. In situations that a caregiver has orthodox drug at home this may be given first. Treatment was reported to be instituted promptly mostly within 24 hrs of noticing fever by all participants.
It is only when the herbs or drugs used are found not to be effective that child is taken to the health care facility. Referral often takes place after about 2–3 days of treatment at home. During one of the FGDs a young mother said: "the first thing we do is to prepare herbs for the child when the body is hot and administer it before drug hawkers come because they don't come regularly".
This was corroborated by health workers at KII. One reported thus: "many of the parents first treat their children with herbs. They may also buy drugs from patent medicine sellers and combine with herbs. The reason why they buy drugs from hawkers is that they think the method will work; they come to the health centre when the illness is not responding to the drugs already used".
FGD participants also mentioned that children considered to have severe malaria were usually first treated with herbs and then taken to the health centre when there is no improvement after administration of herbal preparations.
A young mother said: "we give herbs and use leaf and palm oil or black soap to wash the child so that child will get better before taking the child to anywhere (health facility or patent medicine seller)".
The orthodox drugs commonly used in the home management of malaria were chloroquine and paracetamol. However, many mentioned that they lacked adequate knowledge of the correct use of these drugs and relied on drug sellers' instructions. The common sources of drugs in the communities were itinerant drug hawkers and patent medicine sellers who sometimes also hawk drugs. The major barriers to accessing health facilities identified were non-availability or erratic supply of drugs in the health care facilities, distance of some of the communities to the health centres, poor transportation system in the rural areas and financial constraints on the part of the caregivers. Other barriers were related to the negative attitudinal disposition of the health workers. These include absenteeism of health workers [HW] and unauthorized charges for treatment, which may not be affordable. Reasons proffered for HW misdemeanour include HWs' displeasure at being posted to the rural area and problems with transportation from the city [where most of them reside] to the health centre in the rural area; while some participants believed that some of the HWs were just out to make money.
The estimated cost of treatment (based on caregivers' judgment) for an episode of febrile illness in a child if orthodox drugs were used ranged from ₦100.00 – ₦7000.00 [90 cents to 55 USD). The estimated cost for home management ranged from ₦100 – ₦500 [90 cents – 4 USD] while treatment at health facilities was estimated at ₦500 – ₦2, 000.00 [4 USD – 17 USD] for out patient treatment and ₦2,000.00 – ₦7,000.00 [17 USD – 55 USD] if the child was admitted for in-patient care. These estimated costs included cost of the different types of drugs given and the cost of transportation which ranged from ₦20.00 to ₦500 [16 cents – 4 USD] to travel to nearby or distant village or to the city of Ibadan.
Awareness and willingness to use artemether-lumefantrine (AL)
None of the participants at FGD had heard of AL at baseline. A few of the health workers mentioned they had learned of government's intention to distribute the drug but have not seen it before. All the participants were favourably disposed to the introduction of AL for treatment of malaria in their children provided it is an effective drug. One young mother said:
"Since you say it is very effective, bring it for our children. We will have peace of mind because the incidence of children falling sick often and often will be reduced".
The older mothers and fathers referred to the caretaker role of the government. They mentioned that it is the responsibility of the government to look after the health of her people, as such; "it is a good idea, if the government introduces it into the community".
Comprehension and Understanding of the Package of AL
In order to determine the FGD and KII participants' understanding of the illustrations on the package of AL and the appropriateness to the local setting, samples of the AL (Fig 2) to be distributed were shown to the participants at baseline. Most of the participants recognized the pack of AL as drug meant to be taken by children because of the picture of a child on the pack. However, their explanations on the use based on illustrations on the pack were mostly incorrect. Some said it is for malaria because the colour of the tablet is yellow and because a mosquito which was perceived to be a cause of malaria is drawn on the pack. Many participants could not comprehend how to administer the drug by just studying the drawing on the pack. The responses are that one tablet of AL is to be used three times a day for two days (1 × 6 pack); one daily for six days (1 × 6 pack) or twelve days (2 × 6 pack) and that the tablet is to be divided into two because each tablet has a line down its middle.
They requested to be given verbal instruction and training on how to use the drugs for better understanding and correct usage.
Opinion about drug distribution process
There were mixed opinions amongst participants regarding the preferred outlet for the distribution of AL. The outlets mentioned were the existing health centres, drug sellers (PMS and drug hawkers), trained mothers, community leaders and research team. The most mentioned was through trained mothers. A few mentioned that drug should be distributed to each household based on the number of children therein. However, from the reasons given for preferring one to the other, many of the respondents raised objections to the use of drug sellers especially drug hawkers followed by health workers. Only a few raised objections to use of mothers while none raised objection to the use of community leaders and research team. The FGD participants were of the opinion that the PMS and health workers will sell the drugs to them even if meant to be distributed free or hike the price if they were to be sold. The anxiety expressed by the mothers and caregivers stemmed from past experiences where by some drug sellers and health workers had demanded money for drugs that were meant to be free or hoard the drugs for their own private use. Another concern expressed by the mothers was the HWs irregular attendance at work. Quotes to support these responses included:
"Yes, use mothers for the distribution of the drug in this community, don't use drug hawkers, because they may sell it and people that cannot afford it will not be able to buy "- said a young father.
A "traditional ruler" of one of the communities said: "Give the drug to us, we will give it to the mothers and also give it to health workers at the health centres to give to children that are brought to the centre".
Assessment of intervention after one year of distributing AL
Awareness and use of AL
Most of the participants at FGDs held after one year of distributing AL mentioned that they have heard about AL. A few participants in the FGD groups for fathers mentioned that they have not heard about the drug. One quotation to corroborate their awareness goes thus:
Yes, we have heard about the drug and have the treatment guidelines. It is for treatment of malaria in children and it is good" said a young mother. Participants also mentioned that they used AL to treat their children during episodes of febrile illness presumed to be malaria. This was supported by this quotation:"since you introduced the drug into our community, mothers go to the CMDs to collect drug for febrile children presumed to have iba". Treatment was reported to be instituted promptly mostly within 24 hrs of noticing fever by all participants. A young father said:
"Mothers go to collect drugs from CMDs as soon as they notice "iba" in a child. They use the drug quickly, because they know if they delay, the illness may progress and prevent them from going to their work".
Most of the participants mentioned that children suffering from severe malaria are supposed to be taken to the hospital/health centre as the first line of treatment. However, few participants, mostly older mothers' and older fathers' still mentioned herbs as first line treatment and would only take such children to hospital if there was no improvement. In one FGD group, a mother admitted that she took her child to the health centre after tepid sponging and putting a mouth gag (teaspoon wrapped with cloth) when her child had symptoms suggestive of severe malaria (very high fever, vomiting and convulsion/fits).
Most of the participants who had used AL mentioned they were able to understand the dosing schedule after the training by CMDs who also provided instructions at the point of collection of the drug. The participants also mentioned that the guideline which was provided as hand bills to the households aided their understanding of the dosage regimen for AL. However, a few FGD participants who were mainly fathers and "old mothers" mentioned they did not understand the illustrations on the pack. All the participants who had used AL mentioned that the cost of treatment of a febrile child reduced drastically with the distribution of AL. The cost was less than 50 cents (USD) when AL was being sold. When it became free, the cost incurred was mainly for other drugs such as paracetamol and multivitamins when prescribed. There was no transportation cost since drug was available within walking distance.
Drug Distribution
At the end of the intervention, participants expressed satisfaction with the idea of keeping drugs with people within the community. They mentioned that PMS and "mother trainers" were not far from them and were always available when needed be it day or night.
One young man attested to the effectiveness of the 'mother trainer' in his community. He said: "The mother trainer you selected in my community put a lot of effort to ensure that people know about the drug and use it. She goes around educating people, creating awareness and she is always available. Please help to reward her".
None of the participants mentioned that any of the CMDs charged illegal fees. Many of the young fathers mentioned the drug was given to the caregivers free. During KII, opinion leaders mentioned that they appreciated the wide distribution and availability of the drugs within the community. They also mentioned that people in the neighbouring communities took advantage of the facility and that drugs were always available unless the CMD was out of stock. A young mother said: CMDs are always available. It is good we have two in our community, when one is out of the village the other one attends to caregivers. One participant expressed the view that it would be useful if CMDs are allowed to hawk AL because many people in the rural areas cannot afford the cost of transportation.
Patent medicine sellers and health workers welcomed the involvement of PMS and trained mothers for distributing AL. This view was premised on the fact that PMS and community members were readily available compared to health workers who are available only during official hours and sometimes irregularly. PMS had some reservations about having to replenish their stock at the health centres. The PMS would rather have drug stocks supplied to them directly by the research team. They were also willing to collect AL directly from the drug store at LG headquarters. The PMS were dissatisfied because they have had to make repeated visits to health centres before they could replenish their stock as the health workers were either not at their posts or they have closed before CMDs get to the health centre. One said: "some of us do not have time to go to health centre especially when repeated visits have to be made".
Adherence to use of AL and occurrence of adverse event
The consensus during the FGDs and KIIs conducted post intervention was that the people in the community used AL very well. A community head said: "all children in my community used it whenever they have a febrile illness. The drug is very good and we will like the use extended to older members of the community too".
Participants at FGDs comprising mostly young mothers and fathers mentioned that they refer to the treatment guideline to check for the dose of AL. Most of the FGD participants mentioned that the mothers completed the dose as instructed and this was corroborated by PMS and health workers. However, some participants in the young fathers' group mentioned that not all the mothers completed the dose of AL. One of the participants specifically mentioned that his wife did not complete the dose in the treatment of their child. When the issue of non-completion of AL dosage regimen was discussed further, the fathers mentioned that some mothers stopped administration of AL when the children are better. Some mothers however disagreed and maintained that non-completion of dosage regimen was an exception. One young woman corroborating the reason given by the young fathers said: "Some mothers may forget to complete the dose more so when their children get better and are playing around".
Effectiveness and Safety of AL
All the participants mentioned that AL was very effective and that they were satisfied with it. A PMS said: "The child I administered the drug to got well and started playing soon after commencement of the drug; the drug worked very well beyond our expectations".
An old mother was particularly impressed with the rapid improvement observed in the health of the ill children following administration of the AL. She said "whenever a child is given the drug, the fever goes down quickly; child starts to eat better and goes to play by the next day. It makes the children strong again". A young father corroborated the assertion and said: "the use of AL has led to a marked reduction in time caregivers spend with a sick child because the children now recover promptly and by the second day of use many of the sick children were up and about".
Reports of adverse events following the use of AL were few and far between. When asked about adverse events, one woman noticed skin rash which she attributed to measles infection. One PMS mentioned that he heard that a few of the children in another community experienced mild skin rash and passing of dark stool. However, these were not serious and did not warrant an intervention.
Opinion about the implementation of the program
The consensus among all participants was that the program went well and they perceived AL to be effective in the treatment of malaria in children. An opinion leader said:
the project has been very useful to us as a community and our children. Since the distribution of AL started, our children have been receiving prompt and effective treatment for malaria. All those treated with it got well with no adverse event. The drug is good.
The health workers stated particularly that they pray that the collaboration between the health centre and the other CMDs continues.
Sustainability of the programme in the community
The issue of sustainability of the programme was a major concern. Before winding up the study, meetings were held with stake holders in the two health districts to deliberate on possible ways of sustaining the program when the research team must have withdrawn their services. A number of suggestions were made at FGDs with caregivers and KIIs with PMS and opinion leaders. All the suggestions had the desire for sustainability of the programme in common. Other key suggestions concerning sustainability of the programme were:
▪ It was suggested that community leaders make it mandatory for community members to donate towards a fund which is to be set up with the sole aim of providing transport or transport fares to CMDs to collect drug from distribution point and providing incentives to the CMDs.
▪ The community should cooperate with the CMDs and give them the required support. The participants mentioned that they will be ready to assist CMDs create awareness.
▪ Some FGD participants mentioned that the Government should adopt the programme and continue its implementation
▪ FGD participants were particularly insistent that CMDs be remunerated as this will serve as motivation to continue their laudable service to the community. The remuneration was considered necessary because CMDs were sacrificing time they should spend pursuing their personal business on community service.
▪ Drugs should be made available at all times and should be stored only by trained CMDs. It was also suggested that drugs should be supplied directly to the PMS and 'mother trainers' rather than going to health centre to replenish stock. By so doing the community will be able to monitor the distribution of the drug better, said a PMS.
▪ Research team or LG representative should pay supervisory visits to the CMDs and communities.