There were 157 in-depth and key informant interviews and 11 Focus Group Discussions (FGDs) conducted across the 32 villages. Respondents included village inhabitants, many of them holding community positions such as Alkalos, Chair of the Village Development Committees (VDC), traditional birth attendants (TBAs), village health workers (VHWs), and youth leaders. In addition, village residents, regardless of whether or not they took part in the trial, and MRC field staff were interviewed. Most respondents were women, belonging to the Fula ethnic group, and engaged in farming as their primary activity.
The survey included 864 respondents across the 16 intervention villages. There were no refusals. The majority of respondents were female (66%), belonged to the Fula ethnic group (73%), and listed farming as their primary activity (80%). The median age was 29 (IQR: 19-41); 34% (294/864) reported previous participation in MRCG-affiliated research or programs (Table 1).
Involvement in the MDA trial
Consent and enrolment, coverage, and adherence
Overall, 722 (84%) survey respondents self-reported to have provided written informed consent/assent and enrolled in the clinical trial; 70% (606) had taken the treatment at least once. Almost two third (62%, 534/864) of respondents self-reported no/low adherence and the rest (38%) high adherence. The trial clinical card was available at the time of the survey for 295 (34%) individuals; about half 45% (134/295) had evidence of low adherence (Table 2). It was possible, with the trial clinical card, to estimate adherence by round. The highest uptake was achieved by the first MDA round, followed by the third round. In addition, during each round, uptake decreased fron dose 1 to dose 3 (Figure 1). Self-report of treatment (mean 6.9; SD 2.7) was very similar yet significantly higher than the information on the trial card (mean 6.5; SD 2.7) (paired ttest p-value = 0.001), though the values were highly correlated (0.7).
Barriers to individual involvement in the MDA
Multiple factors affected respondents’ abilities or desires to take the trial medication. Some factors were more relevant at particular phases of the trial; others, such as farming responsibilities, were reported as relevant in all phases, from enrollment to adherence. Interestingly, of those who had enrolled in the trial, 16% (n=142) did not take the medication. Some of them, though enthusiastic to enrol and promote uptake of the intervention among their communities, never intended to be treated:
“R: We went from one compound to another to inform them to come out [because] the MRC staffs have come.
I: Did you take the medication?
R: I did not take the medicine because of the reason I told you that after I take medicine it makes me sick and makes me vomit.”
“R: Since they [MRC] start to give medication in the village I was the one working with them. I have not had anyone complain that he or she will not drink the medication anymore when the MRC people bring the medication.
I: Do you drink the medication?
R: No, I have not drunk the medication.
I: Why is it that?
R: You know since the MRC people came here, I am the one attached working with them. I had an emergency: one of my sisters was sick in Dingiring, her husband was not there, and I was the one responsible to take her to the health facility. Before I came back, I found that time has delayed, so that was the reason why I could not drink the medication.”
Having travelled or temporarily being away from the village was the primary reason for not enrolling in the trial (47% of those who did not enroll) or not taking all nine doses of the study medication (41% of those who took < 9 doses) (Table 3). Those in the age category 18-25 years were significantly less likely to take the medicine at all or have high adherence (Table 4). When asked to elaborate on this finding, respondents explained that this age group was the least likely to take part on the trial because they travel for employment opportunities. Though some may return to assist in farming, young menwere the most likely to travel to the coast or abroad during the time of the MDA:
“No, I didn’t drink the medication. By then I was at the North Bank doing some electrical work. It seems like I am the guardian, but I don’t drink the medication because that very day didn’t find me here. But my wife and my children have all taken the medication.”
Being away from the village at the the time of the MDA round and time constraints related to economic activities - particularly farming - were also important reasons for not enrolling in the trial or not fully adhering to medication: 18% of those who did not enroll and 17% of those who did not complete it stated it was because they were too busy at that time (Table 3). This can be explained by the fact that the timing of the MDA and malaria season overlaps heavily with the rainy season, the most intense period of agricultural production in this region:
“Some people are working on their groundnuts and coos farms, this is what we depend on for survival. We have only two months remaining for the farming period to be completed so we need to work harder.”
Implementation issues impacting medicine uptake included misinterpreting or disagreeing with the conditions or logistics of the MDA, such as distribution times and locations, enrolment opportunities, and eligibility criteria. The requirement to fast for 3 hours before and after medicine intake (for DP) was said to be an obstacle for their regular activities (such as farming) and, for some, was sufficient to refuse taking the medication.
Lack of privacy
As part of the eligibility requirements, women of reproductive age (15-49 years old) were required to undergo a pregnancy test. The implementation of the pregnancy tests varied by village, but it was often a source of concern due to privacy and other issues. In several villages, the location of the MDA lacked a private toilet facility and the results were often read at the same table where people registered. In some cases, women went home to collect their sample, but this required carrying an urine sample across the village. For many, particularly younger women and adolescents, this was a sufficient reason not to enrol or return for additional doses of the medication:
“We all [the entire compound] went to take the medicine, but I was asked to give my urine sample. I told them I am not married, and if it is about pregnancy, I know nothing has happened to me but they insisted that I must give my urine sample before they give me the medicine (…) Because the entire compound was there, and they asked me to give my urine sample, I refused because I am NOT having any relationship with any man, so I would not do it.”
“R: It [the pregnancy test] was done in the open [space], so people were sitting there. When you come and give them the urine sample, they will place it there and people will be sitting there looking at it (…) It should not happen like that.
I: And when did you decide to stop taking the medicine?
R: I stopped taking the medicine last month.
I: Can you tell us why? Anything that made you to stop taking the medicine?
R: Nothing happened, just on menstruation those days. That is why I did not go there.”
Knowledge of medicine and perceived side effects
Respondents’ personal beliefs also played a role in determining whether to enrol in the trial or continue taking the medicine. Some stated that they were too old for the treatment and others did not consider allopathic medicine as the most effective course of action for treating malaria:
“Well, it is a long time I don’t drink medication; I mostly depend on herbs.”
Among those surveyed, 13% said they did not enrol and 10% said they did not fully adhere due to what they considered side effects of the medication (Table 3). Side effects reported by respondents during IDIs included excessive sweating, diarrhoea, vomiting, rash, dizziness, stomach pain, and burning chest or heart. Respondents reported having stopped the medicine intake as a result of personally experiencing or hearing of other community members with such symptoms:
“I have drunk the medication once, but I don’t continue drinking it anymore because since I drink the medication day before yesterday me and my wife vomited a lot, so this is why I will not go and drink the medicine today although I have finished drinking the medication in the first round.”
Specific concerns regarding the mosquitocidal effect of ivermectin were also mentioned:
You gave someone medication to take and when mosquito bites you that mosquito dies, it will also kill flies and lice and bedbugs… Will that not affect the person who took that medicine? That is the reason why some refuse.”
However, though rarer, side effects were not always considered to be a negative consequence of the medication: some respondents described those symptoms as a clear sign that the medicine was having its intended effect.
Enabling factors for individual involvement in the MDA
The most significant enabling factors at all stages included: recognizing malaria as a health concern, believing the trial’s benefits, and attending the sensitization meetings.
Recognizing malaria as a health concern
Both the qualitative and quantitative data showed that although there is a general perception that malaria has substantially declined in the last few years (63% of respondents), it is still considered the most serious health concern in the intervention area as stated by IDI respondents. Despite being a medically pluralistic population that uses Western biomedicine, herbalists and marabouts, respondents reported that going to health facilities is the preferred (87%) and most common option when they experience malaria symptoms for themselves (60%) or a child (44%) (Table 5).
Inhability to perform income-generating activities was cited as the most common non-health impact of malaria (78%), followed by missing household responsibilities (67%), and missing school (57%). However, the costs associated with malaria medication (45%), visiting the health facility (41%), and transport to the health facility (38%) were also named as important consequences of malaria (Table 5). Furthermore, the total self-reported costs of the last malaria-related visit to the health center (the accumulating costs of medication, fees, food, and transport) were significantly associated with increased adherence to the trial for each outcome variable: those who paid more were more likely to enrol, take the medication at least once, and have high adherence (Table 4).
Local communities examined the costs associated with malaria not only as the result of the direct investment necessary to treat it, but also as the cost derived from having to go to the health facility during the busiest time of the year:
“When [field nurse] and team come here, I gather all my family and ask them to go and take the medicine. I make sure all the children take the medicine for three times. I know I am comfortable when they are healthy. I will not be visiting the healthy facility always, I have been spending two, three hundred dalasi to buy medicine; therefore, when I am to stay healthy without paying a dalasi, do you think I will not take that seriously?”
“When the person develops any health problem is his own responsibility. From here to Basse the fare is seventy dalasi and whilst you are in Basse you cannot stay all day without food; therefore, if you people come all the way from Basse and bring us medication here if we accept taking the medication is for our own good and whoever refuses to take the medication refuses at his own detriment.”
Perceived benefits of the trial
The most common perceived benefits of participating in the trial were “improved health” (70%) and preventing malaria (45%). Believing on the trial’s benefits was significantly associated with higher levels of adherence in both bi- and multi-variate analysis (Table 4). Though only a sparse number of respondents cited access to medical personnel or transportation as a benefit on their own, when prompted, 68% and 50%, respectively, said these factors were important trial’s benefits (Table 5).
“Our thoughts with MRC are that they are good and they have good medication, and if you are enrolled with the MRC, if you happen to get sick, they give you free transport from your home to the health facility. After treatment they send you home without paying anything and when they give you medication, you will not pay anything either.”- TBA female.
Receiving the medication was explained along the same line of thought, not necessarily as an individual health protective measure, but as a benefit some members of the family should receive on behalf of the other:
“My elder brother is a motor cycle mechanic. He works the whole day and before he comes back is already late. My father is also a farmer who goes and chases animals at the farms from morning until evening to make sure that the farm is not invaded by animals, and the other two are women that are in the compound are all breastfeeding, so they can’t come. That is why for me as I have time I came to participate in the MDA.”
Attending community sensitization meetings
42% of surveyed women and 38% of surveyed men (41%, n=349, of all those surveyed) reported that they attended the sensitization meetings in their villages (Table 6). Based upon the data from those surveyed, 52% of the attendants were 26-49 years of age. Only 3% of sensitization meeting attendees were girls aged 12-17, many of whom reported during interviews that they were too busy with household responsibilities during the meeting times.
Although IDI respondents were not able to report many details about the information provided at the community sensitization meetings — and in some cases mentioned the meeting was held in a different language than the one spoken in the village — they were generally informed about the main focus (malaria) and activities (medicine distribution) of the trial, as well as the fact that they were not obliged to participate. IDI respondents also referred to the sensitization meetings as means to secure access to material benefits potentially available through their long-term collaboration with MRC:
“When studies like this are conducted in a village, try by all means to allow 3 or 4 people from your family to be part of the study (…) I said this because when there is future benefit for example this [other MRC trial in area], when your compound is not participating in that project you don’t benefit from this project.”
Social influence emerged as an essential factor in all phases of the trial - as both a barrier and facilitating factor. Respondents mentioned they waited to decide on whether or not to take the medication until after they saw the potential side effects it had on other people they know. Physical and social closeness within these villages facilitates this logic. Several respondents mentioned that when external visitors come to the village to introduce a specific intervention, they prefer to postpone their decision to take part on it until the announced services are actually provided, and they can learn from other villagers’ experiences. In this particular case, community members’ experiences with the first rounds of MDA influenced respondents’ decision-making processes subsequent rounds:
“Early on we were scared to drink the medicine because some people were not talking good about the medicine (…) Some were saying that the medicine is good, others were saying that if you drink the medicine it will make you vomit, dizzy, you can have diarrhea and weak body from it. This is what scared us in taking the medication at the initial stage (…) All this information comes out from our conversations because sometimes during our conversations you will meet with your good friends who will attest to you that this medication is very good, and it is very effective.”
Unanimously agreeing with a particular course of action was reported as a sign of cohesion at the village, compound, and household levels, in that order of authority and decision making power. It was believed that these authority figures should act as caretakers and enforce their decisions as a way to benefit the entire village.
“Well in this situation if the whole village decides on something, I can’t dispute it. I will just agree to the decision made by the village leaders, because wherever the village stands that is where I will be.”
“When a whole village is doing something, and you are not doing the same, they consider you differently.”
IDI respondents often reported not having information about those not taking the medication, or referred to decliners as isolated cases or negative examples of community members that could be internally addressed:
“Yes, a few numbers of them didn’t want to participate in the study. (…) But in general, all the compounds are participating (…) the lost people whom you know that they are not educated, and they don’t listen to what the educated people are preaching to them, they are the people who spread bad rumours that MRC takes people’s blood (…) In any community those kinds of people exist. Even in our village, there are a few of them here, but people will not listen to them because everyone knows what is good and bad, and in such a situation we know how to handle such people in our community.”
Although following the decisions of the majority is a well-established social norm, our data also show instances of disagreement among heads of household and village leaders. In those cases, heads of household used their authority to prevent members of their families from taking part in the study:
“I went to [the coast]. When I came back, my elder daughter, I saw the card with her, she went and drink the medicine. I asked my daughter, ‘How you got this paper?’ and she said, ‘it was giving to me by MRC people.” I asked the mother, the mother said she was not aware. I was very angry that time, I took the card from my daughter and I keep it. I told the mother that ‘I think I told you that I do not have interested of this program, so why in the absence of me you sent my daughter to go and take the medicine?’ So, I was angry.”
Having a spouse adhere to the trial was significantly associated with increased adherence for both men and women (Table 6). Women and minors, regardless of their age or marital status, were expected to consult with their husbands or caretakers (or their representatives in case of absence) about their potential adherence to the trial prior to providing informed consent. Women were significantly more likely to require permission to enrol in the trial and needing permission was significantly associated with increased adherence (Table 6).
“I: As a woman, do you agree with reason given by your household head about not to participate in the trial?
R: I will discuss with my husband, try to convince him to participate because it is good. When I discuss with him, if he agrees, we will join, but if he did not agree then I will not join the trial.”
“When they came for enrolment in this compound my mother was not around - she went to Basse to sell. The field worker found me here and asked me to come and enrol. I told him that I can’t give you my consent in the absence of my mother, because I need to seek consent from her first. Then the field worker reacted and said to me ‘you are a grownup person you can decide for yourself.’ I was not happy about that reaction from the field worker and I still insisted that I can’t give consent without my mother (…) Your elder is just your elder, and you know everyone has a position in a family, and for her, she is my parent. And the rest of the children, I am also their elder. Anything I am supposed to do I need permission from her. If she authorizes, I proceed with it; if she doesn’t give me permission, I stop it, so I can’t go beyond her decision.”
Respondents mentioned their capacity to influence their social environment by advising others about the benefits of working with MRC, which was seen as a form of protecting the interests of the village. Acknowledging that elders act as role models for the village, fieldworkers strived to involve this sector of the population from early stages of the process by physically bringing them to their distribution point and having them motivate others to participate:
“Since the beginning of the MDA when the Alkalo and the village elders came, all the elders came as one group and the drugs were given to them (…) He was the first person who came (…) Because they see their elders taking it, why not them? I think this is the step they are following. Seeing their elders taking it, their grandfathers, fathers taking it in front of them, then they should be behind them.”
The role of MRC
MRC’s long-standing presence in the study area also held considerable influence in trial decision-making and adherence. Respondents expressed high appreciation for receiving —what they consider— health care in their own village and mentioned MRC’s presence as an important facilitating factor to increased access to health-care in general. This appreciation was reported to be retributed with unconditional support and trust in MRC activities. In fact, those who were first told of the trial by an MRC employee were significantly more likely to take the study medicine at least once (Table 4):
“For me and my family, I will never step back when it comes to MRC work.”
“Yes, I always tell my people to go and take the medicine, I tell them all the time, I always tell them that MRC does not give medicine that would make people sick; they give medicine to improve our health.”
In some cases, community members assumed a more active role and became advocates for the organization:
“My concern regarding the study is that there are people who know why they are drinking this medication, but there are others whom you know they are drinking this medication, but they don’t know why they are drinking this medication. They are just drinking it for the sake of drinking. So that being the case, I will take that responsibility before the second round. I will go and meet with these people within the compound and talk to them about why they are drinking this medication so that they will know. If not, in the second round when it is time for the MDA, they will start to take excuses by saying ‘I am going to the garden and other places.’ But if they are informed, the second round will be much better.”
Negative past experiences, widely spread rumours regading MRC financially gaining from the sell of people’s blood, and questions regarding research practices also acted as arguments to decline involvement with this particular initiative:
“We were looking at MRC. Like when you participate in an MRC study, they will come for you, but when they find a sick person in the compound, they will not attend to the patient, but they will be interested in taking the healthy person and leave the sick one at home, and that is where we think is faulty. Secondly, we were thinking like when they recruit children in their study, they will take them and bleed them, and you know? People who eat sorrel don’t have a lot of blood. This was the problem. We started discussing with them all that, but they just passed us and left. We didn’t, this was the issue.”