For the quantitative study, a total of 73 CAB members participated in the individual interviews. Of these, 43 (58.9%) were males. The median age was 49 (interquartile range (IQR): 24–70) years. Table 1 shows the distribution of the socio-demographic characteristics of the CAB members.
Of the 73 CAB members surveyed, 42 (57.5%) said they did not attend any research ethics training module. Figure 1 shows the proportion of CAB members who reported to have attended the following courses: research ethics, good clinical practices (GCP), responsible conduct of research (RCR), health research, and human subject protection (HSP).
Of the 73 CAB members, 50.7% reported to have no training on CABs operations. Of those who had at least one training, 63.9% had the ethics training initiated by the trial investigators as shown in Table 2.
For the qualitative study, key informant interviews were conducted with 10 CAB chairpersons (female: 5); 10 trial investigators (female: 3); and 4 community liaison officers (female: 2). The distribution of KIIs by sex and age is shown in Table 3.
Content analysis of the qualitative data identified three themes including 1) skills and ability of CABs to perform their role, 2) the need for training and 3) challenges faced by CABs. Below we present results from the content analysis by these themes.
Theme 1: skills and ability of CABs to perform their role
Respondents noted that CAB members had the skills and ability to understand certain study documents such as the consent forms, the interview instruments, information sheets targeted to the participants and they would therefore, support in the review of these documents and advise the research team accordingly. Different investigators acknowledged that CAB members were supportive in their efforts to have their study materials tailored to their target communities and they were also able to give relevant feedback to the study team on different issues regarding the study.
In most cases they also help us soften the language. For example, these trials are so technical; the language is so technical. For instance, when you talk about randomization, we sit with these ordinary people drawn from the community where we work and then they advise us on how best we can explain this concept of randomization. I remember some time back the first clinical trial we did, double blinded is a concept that I didn’t know how to put across to the communities. But when we met with the advisory board, they said instead of using a single word “kantuntunu” describe the process; describe the rationale behind double blinding of both the volunteers and then the scientific value in the randomization and blinding. And once we did that, then people understood. So that is the primary role that community advisory board members play (KII with Community Liaisons Officer).
We do receive a lot of feedback from them (CABs) because whenever we present to them, they give us quite a number of things; what ideally a person who is not a scientist would have not thought about in a study. So, I think they are very useful; they give very good feedback that is very important in the follow up of these participants and also as we implement the study. They do give very valuable feedback (KII with Trial Investigator).
Theme 2: need for training
Qualitative findings highlighted some gaps in training of CAB members. The investigators mainly focus on training the CAB members on the study protocol and less on general research principles. The training usually includes a lay orientation to the research process and community engagement procedures specific to the trial and this happens at the onset of implementation.
Apart from training them on the protocol, we haven’t yet given them a proper training. There are a number of trainings that can be given to them including research in general but we have not done that yet. As a team, it is a wakeup call for me to plan and have some engagements and train them. (KII with Trial Investigator).
I don’t remember any trainings that we have conducted for our CABs apart from those mini trainings or meetings like the very first CAB meeting where we tell them about their terms of reference, what is expected of them and what is expected from the study team. And then the refresher in the middle so they can always remember their roles (KII with Trial Investigator).
We usually give them an overview about the study, target participants, the eligibility and also ask for their input. We also train them on the planned community engagement activities and then we shall need the CABs especially in recruitment and following up participants. (KII with Trial Investigator).
Other respondents alluded to the fact that CAB members should get trained on other issues important in the conduct of clinical trials such as research literacy and advocacy in community engagement in trials. This however, was often tailored to the interests of the research team in respect of the study they are undertaking.
First, we make them aware and appreciate the role of research in our day to day life, basically research literacy. The second is advocacy- how to engage the communities; and then, their roles and responsibilities as a community advisory member, their mandate. (KII with Trial Investigator)
It was noted that in order to ensure CAB members are adequately empowered to effectively perform their roles, trainings and capacity building for CABs should not be primarily left to the trial investigators and research team. Other stakeholders such as the research regulatory bodies and ethics committees should take up the role of giving capacity to CABs and empower them as required.
In a training session you may mention one or two ethical issues but spend more time on the project and the integrity. That role shouldn’t be left to the Investigators. Ethical training for the CABs should be a role for the REC ( KII with Trial Investigator).
Theme 3: challenges faced by CABs
Whereas our discussions with CAB members revealed that a section of them believed they were performing their roles as expected, other CAB members admitted that they were not as effective as they are portrayed to be. It was reported that CAB members had challenges comprehending certain scientific concepts (such as blinding, placebo, treatment arm, intervention arm and randomization) involved in certain clinical trials.
We need the PIs to support the CAB. We need more relevant information on trials. As CAB members, we need to understand the research language. For example, you are talking about placebo but there are so many members you can ask about placebo and they don’t even know what it is. We need to get to a level where we understand things (KII with CAB Chairperson).
Following a power point presentation, a Professor challenged one of the technical staff on the study and said, “thank you for your presentation but isn’t this too big for these people?” Looking at the composition of our CAB, I am a reverend, the other one is a sex worker. What they need to do is to simplify the information in that language you understand but not the scientific terminologies which confuse us and opt out of the CAB meeting ( KII with CAB chairperson).
The other challenges cited to negatively impact on CAB members’ effectiveness included; lack of independence, lack of necessary guidelines for CABs functioning, limited resources and funding to facilitate CAB’s work, CABs having to participate in different trials concurrently, knowledge gaps about research ethics and the rights of trial participants. The other concerns raised were: lack of basic training in research and limited time as many CAB members do go about their other livelihood activities to fend for themselves and their families.
Theoretically they [CABs] are independent but practically they are not ( KII with Trial Investigator )
There should be a level of independence for them to do and say what their conscience tells them without fearing any sort of reprisal from the research team. They should be in a way that they can do their work without fear or favor and they are respected and it doesn’t put them in any jeopardy and stand for the community as they do for research ( KII with Trial Investigator )
The CAB is a ghost committee; that is what I must tell you (laughs). The CAB committee is there in documents, but they don’t know the work for which it was instituted. And out of all these trial participants, you have invited today, if you asked them who the CAB members are they will not tell you and some of them have never heard about the word CAB (KII with Community Liaison Officer).