From the focus groups and interviews with trial participants and staff, several key issues were identified as particularly relevant to the acceptability of IST-AL and IPTp-SP. These included attitudes and behaviour relating to malaria screening with an RDT along with the perceived side effects, efficacy and adherence of both trial drugs. The clinical trial context also influenced how these interventions were received.
Screening for malaria
The RDT used to diagnose malaria amongst trial participants entailed blood samples being drawn via finger prick. Interviewed trial participants viewed this as a painful procedure but many expressed a willingness to endure the discomfort and discover whether they were suffering malaria.
Respondent (R) 2: For me, I think the prick on your hand to test is far better. When you are tested they will know whether you have serious malaria or not. If you have the serious one, they will know what to do.
R3: For me, I think they will have to test before the give the medicine. If they don’t test how can they start to give you medicine without testing you to know what the problem is.
FGD, women in IPTp and IST arms (Central Clinic)
However, for some, the prospect of a finger prick provoked sufficient fear as to prefer foregoing diagnosis and receiving an anti-malarial regardless of a confirmed infection.
I also prefer to take the [SP] because at times when they are going to prick your hand they won’t warn you, which makes it very painful. That is why I just don’t like it.
FGD participant, women in IPTp and IST arms (Paga Health Centre)
Health staff reported that most women were unhappy with the finger-prick. Observations also suggested that women found the process uncomfortable, often averting their eyes during the procedure. Furthermore, the trial field coordinator described how some women would be deterred from participating in the trial because of the finger pricks.
Some of [the women] say that they are fed up. You know, when they come to us, we do pricking and take blood samples, to know their HB, if they have malaria and so many other things. Some of the women fear pricking and so, when we invite them [to participate in the trial] they won’t come.
IDI, trial field coordinator
The concerns were particularly related to the pain and discomfort of the finger-prick but there had also been complaints about a lack of compensation for the follow-up blood testing of participants from both trial arms. One field worker described how trial participants’ criticisms had led to trial staff providing a bar of soap as an incentive after each finger prick conducted at all trial participants’ homes six weeks post partum. Although trial staff were also aware of problems with blood sampling at other research sites, particularly with regard to rumours of ‘blood stealing’, they had not encountered such rumours, which they linked to the local population’s familiarity with medical research, the small quantity of blood that was sampled and the explanations that were given during the consent process about the reasons for blood sampling. Similarly, there was little reported resistance to the post-partum collection and sampling of the participants’ placentas: although potentially divisive, women were placated by the explanations that they received on enrolment. With regard to clinical research more generally in this research site, one trial staff member explained:
Respondent (R): When we are taking the blood we tell them what we are going to use the samples for. We also tell them that we are not taking much of their blood. So at the end they know that we are using their blood to know their HB and to see if they have malaria but not to give it to some other people. So they cooperate with us.
Interviewer (I): So you think that if you were taking more blood there would be more problems?
R: Yes. If we were taking a lot of blood they may think that we are selling it for money or that we are donating it to some other people.
I: Has it ever happened like that in any trial here in Navrongo?
R: No. In the projects that I know they also don’t take much blood.
IDI, trial field coordinator
Indeed, the observations of the consent process suggest that the trial staff were careful to spell out that trial participation entailed malaria diagnosis via finger-prick and use of the placenta for research. Women were also given explanations as to why these procedures were conducted.
Trial drugs: side effects, perceived efficacy and adherence
Artemether-lumefantrine (AL)
Women’s reports regarding the efficacy of AL were mixed. As the excerpt below indicates, the trial participants experience of the ‘yellow malaria drugs’ had varying degrees of success in terms of treating bouts of malaria. Indeed, respondent 1 in the same discussion explained this in terms of everyone having a ‘different body’. There was however a general absence of direct references to side effects caused by AL.
I: So, this malaria that we are talking about, did it end with the drugs [AL] and come again or did it never even with the drugs?
R3: For me, when I was taking the drug the malaria was still with me.
R1: For me, when I finished taking the drugs the malaria also stopped for some time before it came back.
R5: In my case, when I took the drug I was ok. I did not have malaria again.
FGD, IST-arm participants (Yua CHPS)
In contrast, trial staff described trial participants complaining about AL causing side effects, including nausea, dizziness and appetite suppression. Complaints also centered on the perceived high number of tablets that a treatment course of AL entailed (a total of 24 tablets over three days). One woman was reportedly dissuaded from taking AL by another health worker (who had no association with the trial) who advised that AL was too ‘strong’ for use during pregnancy and that it could lead to miscarriage.
R: [Trial participants] are complaining about the Coartem [AL].
I: What are some of the complaints that they talk about?
R: There are many. They say that to take four [tablets per dose] is too much. They are complaining about the number. They say that even taking one is not easy for them. Some of them don’t eat well before they come [to the health facility], so when they take the medicines they feel like vomiting.
IDI, trial midwife
In spite of the concerns, trial staff were confident about participants’ non-observed adherence to the AL treatment course. Although the women took all but the first dose of AL unobserved, on follow-up visits trial staff collected the empty AL blisters. They based their assertions about adherence on this and also on women’s positive reports of the efficacy of AL in terms of reducing their symptoms of malaria. There was however one report of non-adherence caused by AL-associated side effects: the trial field supervisor had visited a woman whose experiences of dizziness had led her to stop taking the tablets. Based on his advice about the malaria infection not being cured, the participant restarted the AL course. Another woman described how she had taken the treatment course over four days rather than three.
I: So for the Coartem [AL] they take all even if they complain that they cannot eat well?
R: Yes, though they complain they still take it.
IDI, trial coordinator
Sulphadoxine-pyrimethamine (SP)
Trial participants complained directly of side effects associated with SP. These included vomiting, nausea, diarrhoea, appetite suppression or increase, general body weakness, and dizziness. Based on their negative experiences, some women questioned trial staff about the benefits of such drugs, and were told that they prevented malaria and were beneficial for both women and their children. The side effects also varied across the IPTp-SP doses and women did not necessarily experience side effects with every dose.
R1: It is the white large medicines [SP] that are very difficult to take. When you take them you vomit all the time and you also have body weakness and you lose appetite.
[…]
R3: Yes, those three tablets [of SP] are really a problem. When you take them and you get to the house it is always like you are drunk…
R2: When I take them I become very weak and eat a lot…I have never vomited after taking them.
I: Is there any of you here that the [SP] has no effect on?
R4: The first and second time that I took the big white medicine, I did not have any problem but the third time that I took it I vomited lots.
R5: When I took it for the first time and got to the house it was like I had diarrhoea; the second time, the same thing happened but with body weakness; and the third time, when I got to the house after taking the medicine I was a little dizzy but it was just for some short time.
I: And has anybody taken it and had no problem?
R6: I also had a problem when I took them it made feel like vomiting but I could not vomit.
FGD, IPTp-arm participants (Kassena-Nankana East Health Centre)
One trial staff member explained the frequency of SP-related side effects in terms of the poverty and resultant poor diets of pregnant women in the area.
You know, in this part of the country the poverty is high. Some people do not eat until afternoon or so. So, when pregnant women take the SP without food they become dizzy. So we always tell them at least to take [flour and water] with groundnuts before they take the drugs.
IDI, trial midwife
In light of the side effects, trial staff suggested that if SP was not delivered under directly observed therapy (DOT) conditions, women would discard the tablets. However, the staff and even one trial participant recognized the effectiveness of IPTp with SP in terms of reducing the negative effects of MiP, particularly a reduction in miscarriage and improvement in birth weight.
I think the white [SP] tablets are very good because the drug prevents the child from getting malaria. Now you can see that when you give birth to your children they look very strong. Before, many people were losing their pregnancy because of malaria. But now there is prevention.
FGD, participants from both trial arms (Sirigu CHPS)
IPTp and IST within a clinical trial
Trial participants’ attitudes towards the interventions were inevitably influenced by the context in which they were delivered. Participation in the clinical trial was generally popular, particularly because of the health care and other benefits that were offered. Indeed, although the trial enrolment criteria restricted participation to women of parity two and below, health staff reported that women of higher parity sought to enrol in the study, citing the benefits, particularly an ITN (which were not always provided free of charge at ANC) and requested that staff ignored this exclusion criterion. The local research institute, in collaboration with various overseas partners, has conducted a range of clinical studies in the area and trial participants generally valued these activities, again, particularly for the benefits that participants received, which reportedly included lifts to and from health facilities and food. Previous experiences of such benefits, and anticipation that these would be provided, also prompted women to participate in this particular study. Benefits were however the same for participants in both arms of the trial. Therefore they are likely to have affected attitudes towards both interventions in a similar manner.