Enrollment for the pre-trial, Year 1, and Year 2 KIIs and FGDs are shown in Table 2. In total, there were 17 KIIs, 49 FGDs, and 449 participants in the FGDs. Over the study period, enrollment figures fluctuated slightly but were generally similar across years. Pre-trial, KIIs were conducted with Zambezi Region health and political decision-makers and gatekeepers, health extension workers, and NGO field staff. During the trial implementation period, all KIIs were conducted with community leaders, who were male adults. In the FGDs, youth represented about 27% of participants over the study period. KIIs and FGDs by study arm are shown in Table 2. Across the two intervention years, 34 FGDs were conducted with communities enrolled in the interventions: RACD (6), RACD and RAVC (14), rfMDA (5), rfMDA and RAVC (9).
Table 2: Numbers of Key Informant Interviews, Focus Group Discussions, and Focus Group Discussion participants over study period, stratified by informant type and age category
|
Pre-trial
|
Year 1
|
Year 2
|
All years
|
|
N
|
N
|
N
|
Total
|
Key informant interviews
|
Total interviews held
|
6
|
7
|
4
|
17
|
Participants
|
Government or NGO
|
6
|
-
|
-
|
6
|
Community Leaders
|
-
|
7
|
4
|
11
|
Focus group discussions
|
Total discussions held
|
15
|
16
|
18
|
47
|
Participants
|
146
|
127
|
176
|
449
|
Youth
|
35
|
24
|
66
|
125
|
Adults
|
111
|
103
|
110
|
324
|
NGO, non-governmental organizations
Table 3: Numbers of Key informant interviews (KII), focus group discussions (FGD), and FGD participants by study arm
|
Human Intervention
|
RACD
(N)
|
rfMDA
(N)
|
Y1
|
Y2
|
Total
|
Y1
|
Y2
|
Total
|
Mosquito Intervention
|
No RAVC
(N)
|
KII
|
1
|
1
|
2
|
2
|
2
|
4
|
FGD
|
3
|
3
|
6
|
2
|
3
|
5
|
FGD participants
|
27
|
34
|
61
|
20
|
28
|
48
|
RAVC
(N)
|
KII
|
1
|
0
|
1
|
2
|
1
|
3
|
FGD
|
7
|
7
|
14
|
4
|
5
|
9
|
FGD participants
|
57
|
73
|
130
|
23
|
41
|
64
|
*Pre-trial excluded – study arms not assigned
Pre-trial findings
Healthcare-seeking behavior
When asked where community members would go if they suspected malaria, most respondents mentioned public and private health facilities. Many respondents mentioned that elders may visit traditional healers. A male FGD participant explained,
“Older people in their sixties still believe in traditional ways, how they treated malaria before today; it may happen that those are the same people who might still prefer [a traditional healer].”
An MoHSS employee echoed this sentiment in an interview, explaining that a community member’s first response to malaria symptoms depends on healthcare access:
…the community prefers going to traditional healers before they come to the [Zambezi regional] hospital… You look at the community that cannot afford to visit the hospital or the clinic because of the distance, they will probably start with the traditional healers, and from there that’s when they come to the clinics.
Despite the ongoing use of traditional medicine, a male FGD respondent said that “recently it is evident that the difference between traditional healers and hospital is known… traditional healers cannot cure malaria disease...” This distinction was seen consistently throughout the FGDs.
Possible barriers to participation
Comments about uncleanliness were made about the local environmental management educational programs that emphasized tidiness around households to prevent malaria.
Second, multiple participants mentioned stigma associated with human immunodeficiency virus (HIV) and the perceived association between HIV testing and malaria testing. According to a female FGD participant,
“Some would not go for [HIV] testing because they are afraid they might be found to have HIV; our people prefers to stay without knowing [un]til they see that they are very sick; that’s when they go at the clinic or hospital.”
Participants explained that HIV tests have a similar appearance to malaria RDTs and some community members could incorrectly think the malaria tests were for HIV, and therefore would refuse to be tested.
Many respondents anticipated not wanting medication if they did not feel sick or had not tested positive for malaria. One male FGD participant stated,
“It is not all right – medication is supposed to be for those who have been tested.”
However, many participants who said they would not take medication without testing offered factors that could make presumptive treatment acceptable, such as education and sensitization. One man explained,
“People nowadays prefer to be tested by a doctor or nurse before accepting malaria dosage, though others may agree on condition that they are properly informed.”
All but one key informant said they would encourage members of their household and their neighbors to accept presumptive treatment. However, three out of five key informants who were health professionals said they would refuse to be treated presumptively themselves, despite seeing the value for others.
Some FGD and KII participants expressed concern about medication side effects, including the perception that medications can “trigger other diseases in the body.” Respondents anticipated reluctance about completing the full course of medication, explaining that some people will stop treatment once symptoms have diminished, or, alternatively, if symptoms did not subside immediately. Respondents also mentioned that it is common to save medication to treat future illness, given the limited access to care and distance from health facilities. When asked what would help individuals complete the regimen, KII and FGD respondents agreed that community members would appreciate education, supervision, and reminders, especially for the sick, elderly, and those who cannot read.
Possible barriers to IRS were explored during FGDs, with participants sharing feedback primarily based on previous experience with IRS by the MoHSS. Several participants advised the program to include IRS in its approach, as one adult shared, “Workers go to communities to spray against malaria and distribut[e] mosquito nets [which] needs to continue as the people really appreciate [it]”. However, one woman offered some insight into why some people might decline IRS, saying “Others close their doors to those who spray against mosquitoes, claiming they bring cockroaches”.
Community sensitization
KIs and FGD participants suggested ways to sensitize the community about testing and treatment, presumptive treat, IRS, and means of ongoing engagement. According to an older male FGD participant,
“What I personally notice is that when an employed person tells you, people then listen. Those who went to school and are working tend to be influential. What they say is taken seriously.”
Health extension workers, teachers, and nurses were identified as trusted partners to support community sensitization. Participants agreed that better community understanding of interventions would likely lead to higher acceptance. To educate community members, KII and FGD respondents highlighted the importance of visual aids and forms of media, like radio and dramas, to increase the uptake of health and study information. Participants emphasized the necessity of involving the tribal council of headmen, or khuta, for community entry into the study and raising community awareness.
Year 1
Motivation to participate
Participants were motivated to participate in the intervention to receive protection from malaria via testing, treatment, and/or IRS. Watching others in their community suffer from malaria made them fearful of infection. One woman explained,
“After seeing how much elders and kids were complaining of sickness was a reason enough for me to partake.”
Community engagement and sensitization efforts before and during the intervention were noted as important factors that influenced participation.
Perceptions of and attitudes towards reactive focal interventions
Reactions were overwhelmingly positive towards the interventions. Participants said that they valued the interventions provided by the study, and were particularly appreciative that the teams “come in villages.” The behavior and professionalism of the study team and the respect shown for participants and local traditions were reported to be critical elements of successful implementation. One man explained,
“Most people are talking here that they have never seen people dedicated to their work like you showed us, you did not mind if the people were dirty or clean. You have treated them all equal… it’s the elders and the community leaders that are praising the most.”
Suggestions for improved delivery of the interventions, both medical and vector control, included providing additional notices in advance of the visit date, arriving earlier in the day, and quicker processing of participants and houses.
Criticisms included the lack of IRS in communities not receiving RAVC, no distribution of long-lasting insecticide treated bednets (LLINs), the need to remove all furniture from the household to receive RAVC (especially when advance notice of IRS was not given), and a desire to also receive additional medical interventions like testing and treatment for tuberculosis and HIV. With regards to the project being a time-limited research study, participants expressed concern that the interventions were not a long-term strategy. FGD participants also reported that a neighboring community felt jealous that they did not receive the same interventions, because they had been assigned to a different study arm. In another community, rumors reportedly circulated about the misuse of participant blood. One man explained,
“Some people even said the blood you are collecting is for satanic [purposes] and you are going to hand it to the people to use in a satanic way.”
Such fears can spread, and being aware of them as they arise presents the opportunity to confront misinformation with education.
Influences on participation and adherence
When participants were asked why they chose to participate in a given intervention, whether RACD, rfMDA, or RAVC, they generally chose to participate because they were sick, a relative was sick, or because they knew people who had contracted malaria recently.
It’s was my grandkids that had malaria and I received a call… I was told some people were coming to visit me the following day and I should prepare my house to get sprayed because all four of my grandkids had malaria. It looked as though mosquitos with malaria were in my house.”
Here it is clear that a perception that her family was at risk as well as advance notice about when the team would come and how to prepare her house positively influence RAVC participation. Rationale for participation in RACD and rfMDA were similar, with participants naming their own or their contacts recent illness and wanting to learn more about malaria as motivators.
FGD participants were asked about their experience taking the malaria medication, whether they received it in the rfMDA intervention arm or after a positive malaria RDT in the RACD intervention arm. Most participants described positive experiences, such as this FGD participant:
“There was no problem with the time of taking the prescribed dosage by the nurse, people drank or finished the medicine very well.”
FGD participants reported that negative medication experiences did not affect intervention participation or the ability or willingness to finish the medication course. A few participants in three of the 16 FGDs raised concerns about treatment without testing. One FGD participant explained,
“Some people were concerned, why are they giving us treatment? Do they think we are sick of [with] malaria?”
However, this concern was held by the minority of participants; most FGD participants did not feel that treatment without testing was an issue and no FGD participant said they refused an intervention because they disliked the strategy. For example, one woman said,
“There is nothing wrong [with treatment without testing], just continue with what you are helping the communities with, it is your team which is helping people here.
Continued willingness to participate
All FGDs were concluded by asking participants whether they would be willing to participate in the same intervention in the future. Only two of 127 FGD participants said they would not participate, both referring to medical interventions. One rfMDA participant said,
“At least we should be tested first and only give medications to those who are found positive.”
The other, from an RACD intervention, said he would decline because he did not need further intervention,
“I was already tested and I was negative, I don’t feel any sign of malaria.”
The overwhelming majority of participants found the interventions acceptable and reason for future participation included: desire to protect their families from the ongoing risk of malaria, whether via testing, treatment, or IRS, a desire to know if they are sick, and medication effectiveness. Regarding RAVC, participants specifically referenced the effectiveness of the IRS. As one participant explained, “… the spraying that you did, that was very nice. After you sprayed both flies and mosquito were no longer a lot and one could sleep even without a mosquito net.” This visible change in mosquito presence was referenced as proof that RAVC was effective and acceptable to community members, despite challenges removing furniture so IRS could take place.
Year 2
Motivation to participate
In Year 2, the perceived level of malaria risk and convenience of free community-based care and IRS continued to heavily influence decisions to participate in the trial interventions. In one FGD, a woman commented, “The disease is affecting us so much that is why we have decided to participate,” which is particularly noteworthy given the malaria outbreak the year prior (in 2016). Furthermore, one FGD participant remarked on the accessibility of the services,
“When you go to the clinic you will pay ten [Namibian] dollars going and coming back, even pay something again at the clinic, also you will find queues at the clinic, but the malaria team would come in the village to test and treat without you paying anything.”.
All four community leaders interviewed (key informants) confirmed that people appreciated no-cost, community-based interventions. FGD participants expressed their gratitude that the study teams visited communities twice to ensure everyone had the opportunity to participate in RACD or rfMDA, and RAVC where applicable. The education offered by trial teams was also important to participants. One participant explained, “…always the nurse would explain the dose and the signs of malaria to the community; for the past six years we thought malaria is a headache so now we know the difference”.
Perceptions of and attitudes towards reactive focal interventions
Most participants responded positively to rfMDA, based on the belief that rfMDA protects people from illness. There was a continued emphasis on the importance of community members’ understanding of malaria and the rationale for presumptive treatment, with both FGD participants and headmen requesting ongoing education. When participants were asked whether rfMDA or RACD was preferable, based on their experience with one intervention and a description of the other, the majority preferred rfMDA. Concerns around RACD included: blood being used for satanic purposes or for HIV testing, and the perception that non-positive individuals miss the protective benefit of the medication, since only RDT-positive individuals are given medication. Headmen were more neutral regarding intervention preference, stating that their main objective for participation was to improve the health of their community, and therefore were pleased with all community-based interventions.
RAVC was generally perceived as a useful tool for malaria prevention. Participants in study arms that did and did not receive RAVC expressed a desire to have their houses sprayed against mosquitoes. Actellic CS was generally perceived to be “stronger” and more effective than DDT or Deltamethrin, the insecticides used by MOHSS at the time of the study. However, some participants noted strong smell, coughing, difficulty breathing, itchy eyes, and felt the chemical was too strong. A few participants reported seeing mosquitoes right after RAVC and questioned its effectiveness.
Influences on adherence and participation
Suggestions for improvement aligned with Year 1 findings, where residents and headmen asked that visits by trial teams be better timed and communicated in advance, and requested additional interventions such as mosquito repellants or LLINs. The majority of those who did not participate said they were unavailable at the time of the intervention. However, some non-participants expressed a low malaria risk-perception, as one person said,
“[It was] my will not to participate because I am always exercising, so I will not get malaria.”
As in Year 1, a few community members described refusing because they disagreed with presumptive treatment. During an interview, a community leader emphasized that the main reason for refusal was likely a lack of knowledge about malaria risk. He said, “Some people were misinformed or did not get the right information of what exactly was happening in the malaria program.”
Continued willingness to participate
All but one FGD participant expressed willingness to participate in the same intervention again in the future. All community leaders said they would welcome the intervention teams again. The lone dissenter, a male participant, had participated in rfMDA + RAVC and said,
“At least we should be tested first and only give medication to those who are found positive.”
Furthermore, some participants said they preferred vector-based interventions over those involving testing and/or treatment. As one woman explained, “I don’t like tablets, maybe [I would participate again] to have my house sprayed only, I don’t get healed when I drink tablets.” A few other respondents agreed that combining medical and vector-based approaches, or delivering vector-based approaches only, were important to protect all members of the community.
Refusal during trial implementation – Years 1 and 2
RACD or rfMDA was offered to 1,372 and 8,994 individuals during years 1 and 2 of the trial, respectively. Refusal rates (Table 3) were higher for rfMDA compared to RACD both years, though low for both interventions in both years (<2%). The refusal rate for RAVC was high at 13.9% in year 1. As indicated in FGDs, refusals were due to lack of notification before arrival, and reluctance of community members to move furniture at short notice. Of note, few households (n=72) were offered RAVC in year 1 due to staffing limitations (10). In year 2, when <1% refused, more households were offered RAVC (n=923) and advance notification was provided. RAVC could not be compared to no RAVC. RACD, which was offered at the individual level, could not be compared to rfMDA+RAVC which was offered individual and household levels, respectively. All interventions were able to meet or exceed the goal of 80% acceptance of the intervention among those offered the intervention.
Table 3. Refusal rates for RACD versus rfMDA among participants, and for RAVC among households
|
Year 1
|
Year 2
|
|
N
|
Refused
|
p-value
|
N
|
Refused
|
p-value
|
RACD
|
894
|
3 (0.34%)
|
0.05
|
4711
|
10 (0.21%)
|
<0.001
|
rfMDA
|
478
|
8 (1.7%)
|
4283
|
36 (0.84%)
|
RAVC
|
72
|
10 (13.9%)
|
-
|
923
|
2 (0.22%)
|
-
|
Willingness to participate in future interventions
2,147 people participated in the acceptability portion of a cross sectional endline survey that was conducted in 2017, after most study interventions were implemented. Almost all respondents (94.3%, n=2024) said they would participate in the same intervention if offered again. Of respondents residing in clusters assigned to RACD, 95.5% (1,546/1,619) said they would participate in a future round of RACD (Table 4). The most common reason for accepting RACD in the future was to know whether they were ill. The most common reason for not accepting RACD in the future was that they tested negative for malaria recently. Of respondents residing in clusters assigned to rfMDA, 90.5% (478/528) said they would participate in a future round. The most common reasons for accepting rfMDA in the future were because it is free and because they wanted to prevent and treat malaria. The most common reason for not accepting in rfMDA in the future was concern about medication side effects. Of participants residing in clusters assigned to RAVC, 98.7% (616/624), said they would participate again. The most common reason cited for future participation was to keep mosquitoes and bugs away.
Table 4. Primary reasons for willingness or unwillingness to participate in future interventions as assessed in an endline survey.
|
N
|
Willing
|
Unwilling
|
Don’t know/No response
|
RACD
|
1619
|
1,546 (95.5%)
Reasons:
714 (46.2%) To know whether they were ill
380 (24.6%) To know whether their children were ill
286 (18.5%) Care was free
|
28 (1.7%)
Reasons:
17 (60.7%) Tested negative for malaria recently
4 (14.3%) Afraid of needles
|
45 (2.8%)
|
rfMDA
|
528
|
478 (90.5%)
Reasons:
153 (32.0%) It is free
147 (30.8%) To both prevent and treat malaria
105 (22.0%) Like to have their children treated
|
31 (5.9%)
Reasons:
26 (83.9%) Worried about medication side effects
14 (45.2%) Do not want to take medication when not ill
|
19 (3.6%)
|
RAVC
|
624
|
616 (98.7%)
Reasons:
522 (84.7%) To keep mosquitoes and bugs away
89 (14.4%) Structures were sprayed well during the previous visit
|
7 (1.1%)
Reasons:
2 (28.6%) No mosquitoes in area
|
1 (0.16%)
|
Note: Some participants provided multiple reasons.
Of 528 participants who reported receipt of rfMDA, 77.5% (n=409) rated rfMDA as equally or more acceptable than MoHSS RACD. Of 624 participants who reported receipt of RAVC, 97.4% (n=608) found RAVC equally or more acceptable than MoHSS-delivered pre-season IRS.