Following a description of message development and content, and delivery of key messages, for both trials, we summarise reactions and recommendations first to the end of trial results, and then to the feedback process followed by the trial teams to deliver those results.
Message development and content
Both trial teams drew on recommendations from parents of participating children, the local dispensary health committee, researchers at the KEMRI Centre, and study fieldworkers when preparing feedback sessions. For the FFM ME-TRAP study, this process was formalised through a social science sub-study to the main trial.9
This sub-study illustrated that the inter-personal interactions and relationships between researchers and community members, and within the community, played a critical role in participants’ perceptions of trials, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. Specifically there had been concerns that non-participants in the trial were spreading rumours about the dangers of the trial to children, including that blood was being taken by researchers for dubious purposes, and that this would eventually lead to children in the study dying. These relations contributed to participants’ parents recommending during the trial that:
- the success of the vaccine at end of study should be ‘the first thing’ that is fed back;
- participants should receive some form of recognition from the principal investigator or KEMRI for ‘hanging in there’ against all odds; for their contribution to that success; with suggestions including a party, and gifts.
- the relationship between researchers and study participants should not be suddenly cut-off after the trial; that there should be some form of on-going reciprocity; and
- there should be separate meetings for participants and general community, with any negative results kept secret from non-participants.10
Recognition of the above concerns, and of parents’ priorities generally, contributed to an emphasis in feedback plans on individual child status results (for example number of times the child had been unwell, including with malaria, and the haemoglobin (hb) status of the child over time) as well as overall trial findings for the FFM ME-TRAP study. This was in order to reassure parents of the child's own health status over the course of the trial despite the overall negative trial findings (). Also included in the general key messages was: information on what next, including continued follow-up and the introduction of another trial in the area; reasons why children's health overall had improved; a farewell and thanks from the researcher overseeing the main trial; and information that rabies vaccines had been donated to the local dispensary for use by any needy community member. Other information covered in individual feedback sessions was illnesses observed and treated.
Key messages given during the FFM ME-TRAP and RTS,S/ASO1E studies
For the RTSS trial, a priority was to present aggregate trial results to study participants before they appeared in an international publication, and the national media, but timed to ensure that results did not leak out to media in advance of planned press releases. The latter was based on an embargo from a journal. Individual results (specifically which trial arm the child was in) were not given out together with the general trial results, because of the importance of continued blinded follow-up of children. The focus of the aggregate results sessions was on the 53% efficacy, and on showing that while this was generally considered a positive message, malaria preventative measures were still essential for all. Individual results will be given on completion of the follow-up.
Summary information sheets outlining the key overall study results were prepared in Kiswahili and English for both trials.
Delivery of key messages
FFM ME-TRAP. Following a briefing meeting with fieldworkers, aggregate feedback meetings for the FFM ME-TRAP study were held in five villages over a three day period (n = 6 meetings; 40 minutes to 1 hour twenty minutes for each meeting). Both parents were invited by fieldworkers to meetings in their own villages, but in practice relatively few of the 15–43 parents who attended each meeting were fathers. The meetings were led by the principal investigator (PI), supported by fieldworkers and the chairman of the local dispensary health committee. Following general information and discussion with all parents present, leaflets with general trial results were distributed. Parents of each child were then given their child's individual test results (for example on number of malaria cases over the trial), also summarised on paper. Fieldworkers later delivered results to non-attendees in their homes, including leaving a copy of the results sheets. The follow-up process took approximately one week.
RTS,S/ASO1E. 5 general study feedback meetings led by the PI and senior fieldworkers were all convened over two days, for the reasons outlined above. The format was similar to the FFM ME-TRAP process, although fieldworkers received the results for the first time together with the parents rather than before them. It was explained that individual children's results would not be released until a follow up study for which ethical approval was being sought. The importance of remaining blinded to trial arm was discussed. Information sheets were not distributed at these meetings primarily because of concerns that the data might be circulated in advance of the media discussion, but also because of doubts about the value of the printed material, and even worries that the key messages might be misinterpreted when read in a setting where they could not be discussed. Fieldworkers later delivered aggregate results verbally to non-attendees in their homes.
In both studies, fieldworkers invited parents to the feedback meetings, attended feedback meetings and assisted with interpretation at the meetings, and delivered results to parents who had not attended the meetings. They also followed up parents informally in their homes and in day to day interactions in villages to find out what concerns/questions they had after receiving the results.
Overall reactions to the study results
The key overall difference between the two trials was disappointment with the news of the FFM ME-TRAP vaccine's inefficacy (something which emerged in discussions and interviews more than at the feedback meetings), contrasting with excitement to the news of the RTS,S/ASO1E vaccine's safety and apparent efficacy. Nevertheless the level of disappointment for ME-TRAP was not as great as expected. It appeared that many parents were either not convinced of the results, or believed that those results were irrelevant, given their own child's improvement:
So they are saying it didn't succeed, but I am saying it succeeded because I can finish 3 months before my child gets sick, [and since I joined the study] I forgot about going to the hospital. So whoever knows much is the one who says it didn't succeed, but on my side, I see it working because I had problems [before the trial] … (Father, FFM ME-TRAP study)
Less commonly, parents in the FFM ME-TRAP expressed concerns over their child's future health, saying that they were worried about the new research team and requesting for continued contact with the research team that they already knew. Occasionally, parents indicated that disappointment might lead some parents to withdraw their children.
For the RTS,S/AS01E feedback meeting, several parents wondered why their children should continue using bed nets if the vaccine had been found to be effective. This might have been linked to some confusion of what the key results actually meant, not only among the participants’ parents but also among field staff:
Let me say this, (pause) I am saying this on behalf of many of us. If we, the fieldworkers were not able to grasp the concept of how the 53% protection was arrived at, then we highly doubt if [the] majority of the parents understood it (laughter from other fieldworkers). Knowing the low literacy levels of the parents and the technical explanations that were given, to be honest, [the] majority of these parents did not grasp the concept. (RTS,S/AS01E fieldworker).
Other indications of parents not comprehending or believing the key messages were some parents describing both the malaria vaccines and rabies vaccine as on trial; leading to some FFM ME-TRAP parents reporting that the rabies vaccine had also ‘failed’. For RTSS, the reason why the individual children's results needed to be held back until the end of the follow up period was unclear to some parents.
Overall there were similarities across the two trials in what parents were most interested in finding out about and in what they most appreciated (). There was an interest in what benefits and support individual children and families would continue to get, whether those in the trial would receive the vaccine they had not yet received, and (for RTSS) whether all children in Kenya would now receive the vaccine. Parents appreciated the continuation of medical services and cessation of sample taking for research purposes. For the FFM ME-TRAP study, parents appreciated having received both individual children's and aggregate results, the continued employment of fieldworkers from their communities, and the researcher having come to say goodbye. The continuation of medical services also reportedly helped them save face in the community following the ‘failure’ of the vaccine trial, and assured them about the research team's motivation and continued support.
Similarities in reactions to receiving results in both studies
Parents in both studies requested reciprocity as a reward for having co-operated with the study to the end, including for example farewell parties, gifts, and the upgrading of the local dispensary or building of new dispensaries. Of interest was that in the FFM ME-TRAP study, there was a negative reaction to news that rabies vaccines would be donated to the dispensary for use of anyone in need, with several parents vehemently protesting in feedback meetings (Box 1
). This sense of participants owning the study benefits was even stronger in group discussions, with parents arguing that non-participants should not have access to the study-related benefits, and should not be given preference in participation in the upcoming study (since they had not ‘offered’ their children for the current study); and should not be given free malaria vaccines when the vaccine is finally developed.
Box 1. Reactions by some parents in ME-TRAP to news that the rabies vaccine would be given to the dispensary as a benefit to all community members needing it; regardless of study participation
“The rabies vaccine should be given to those who participated only but not to those that refused to participate. Even if a dog bites one, they shouldn't tell them there is the vaccine at the dispensary. They should go to Kilifi [hospital] because this vaccine is for those that participated!”.
“We do not accept! We do not accept it at all! And if you do so, we will withdraw completely from the study! We want to be vaccinated: us, our children, our husbands and even our dogs!”
“Maybe they [non-participants] are the ones that will be bitten by dogs and we will not get that vaccine …”
(Mothers, FFM ME-TRAP study)
Community views and recommendations on how to feedback results
Receiving feedback was very much appreciated by parents, and for the first trial in particular it was appreciated that many of their ideas and recommendations had been included in the process and that the researcher had come to say ‘good-bye’. Across both trials however there were some concerns raised about the processes followed. Regarding, amount of information and form it is given in, some RTSS mothers attending the feedback sessions reported information overload, and concerns about not having received a leaflet:
How do you expect us to remember and deliver the same information you have given us to our spouses and other members of the family? (Mother, RTS,S/AS01E study)
We are used to taking written documents to our family. You should have given us our own copies of what you were reading to take home. (Mother, RTS,S/AS01E study)
Those not able to attend the meetings but who did receive a leaflet commented that it was an inadequate source of information on its own. News that the individual children's results in the RTS,S/AS01E study would not be released at that time were not well received by most parents:
You did promise to inform us of the results at the end of this study. You have now changed your mind. What guarantee do we have that you will not tell us the same story at the end of the next study? (laughter from the other parents) … (Father, RTS,S/AS01E study).
There were also concerns about who was involved when. That the trial findings were given to parents first was appreciated in both trials, but some queried the time taken between the end of active sample collection and receiving the feedback. Some dispensary health committee members and fieldworkers complained in RTSS about inadequate involvement in feedback planning, and not having received the results first.
Withholding trial information from fathers and non-participants (FFM ME-TRAP)
Some mothers had apparently not informed their spouses or others about the study results, or about which particular arm of the trial their child was in. One reason appeared to be mothers being fearful of their spouse's reaction to information that the child had received the ‘failed vaccine’. This may have been linked to other gaps in information between mothers and husbands, including in details given out during study enrolment. It appeared that some mothers told their spouses about trial benefits and left out potential side effects, and that some even decided not to inform the father about the child's involvement at all. Another reason was a perception that the results should not be shared. This may have been the result of feedback sessions being held for participants only, and of individual results only being given out to a participant's parent because they are confidential. Confidential is often translated by research staff into local languages as ‘secret’. Finally, some mothers did not report results to non-participants to minimise embarrassment, mockery or new rumours resulting from the news of the vaccine being ineffective.