Meet the Scientist: Zandile Ciko on IAVI’s community engagement work

In this episode of Meet the Scientist, IAVI’s podcast series, we sat down with Zandile Ciko, a community engagement manager with IAVI based in Cape Town, South Africa, to explore her work toward conducting safe and ethical clinical trials of IAVI’s Lassa fever vaccine candidate in Africa. From community advisory boards to Good Participatory Practices, Zandile covers the essential elements of IAVI’s people-centered engagement framework.

Tune in to discover how Zandile builds relationships between communities and researchers with the end goal of minimizing social harm and increasing public participation in potentially lifesaving studies.

Below is a full transcription of the podcast.

Welcome to another episode of IAVI’s Meet the Scientist podcast. My name is Rose Catlos, and I’m a communications director with IAVI in our New York office. Today, I’m joined by Zandile Ciko, a community engagement manager with IAVI based in Cape Town, South Africa. On today’s episode, we’ll be talking about Zandile’s work with the community engagement team — a group within IAVI that ensures IAVI-led clinical trials are designed and conducted in partnership with the local communities that will be participating in the trials. This process is essential to ensure that IAVI’s research in HIV, tuberculosis, and emerging infectious diseases is conducted safely, ethically, and in a way that doesn’t further stigmatize or marginalize community members.

Zandile, welcome, and it’s such a privilege to be speaking with you today.

Thank you so much, Rose. I appreciate the invitation.

Zandile, if we could, I’d like to start out with the very basics. One, what is community engagement and what does that work look like on a daily basis for you?

Community or public engagement is really just a process of building and sustaining relationships between sectors or the public services with communities. So, it would be community group stakeholders and really people that have a vested interest in the outcome of said project or, even in terms of our work, said research. Our role really involves us preparing the sites to conduct ethical clinical trials and we do this by following the GPP framework, which is called the Good Participatory Practice Framework. And it really makes sure that, in terms of the clinical trial at all levels, you’ve got community and stakeholder engagement. So, during preparedness, you do your research formative activities. We also work on recruitment and retention strategies — really trying to make sure that those strategies and those plans are informed by stakeholders and communities. And then, of course, all the way to dissemination and study closure. So, really making sure that we’re closing that loop and that, in the clinical trial implementation, communities are considered, they’re giving their recommendations, they’re giving their input, and really looking at what strategies we are going to use to ensure that.

So, you really ensure from end to end that communities are involved in every aspect of the clinical trial development and deployment.

That’s correct. And we’ve got a few ways and strategies where we do that. So, for instance, in the protocol development stage, we would ask the community advisory boards to review the protocols and really give us the input around that — especially with regards to the quality of the work that we are going to be doing in terms of procedures. Do they actually work for said community? Also, how to communicate very difficult procedures in the research itself to participants and to communities as a whole, and to also work in terms of the ICF process (the informed consent form). Does it actually make sense to the community member that wants to volunteer for a trial and what, or how, should we be communicating very important aspects within the trial in the form? So, we try by all means to really get community input through working with said stakeholders through all levels, as you said it “end to end,” but really in the formative research activities.

I just want to take one step back and define for folks: what is a community advisory board and what role do they play in the formation of a clinical trial protocol?

It really is a way to engage, or sort of a formal way to have a bridge between the community as well as the clinical research site. What we’ll do is we will have a group of stakeholders that are what we would call gatekeepers within the community — stakeholders that really need to be involved in all aspects and all activities that are happening within the community. We bring them together so that we always make sure we get their input within the study, but also just in terms of what is happening within the community. So really having an ear in the community — a constant ear where even if we are not necessarily in the community at a set point, we know what’s happening, we can hear how the study is being received, what are the concerns that are being raised. Things that maybe we might not necessarily consider. So that is what a community advisory board does.

And that sounds really important for the types of clinical trials that we do as IAVI because we’re often working with populations that are at high risk of disease or living with HIV and there can be a lot of stigma associated with HIV, tuberculosis, and other emerging infectious diseases. And so, it’s really important to protect them and also to understand how the research is going to impact them.

And that’s so true. You know, we look at things such as social harm, right? What is the social harm that a participant may face when joining an IAVI study? We also look in terms of how we communicate that to participants so that they are able to evaluate that for themselves and make that assessment in terms of joining and volunteering for the trial. We look at issues management. So, what happens in the community when you are conducting community engagement activities? We live in very, I would say, fluid communities. Today, there might be no issue within the community, everything is going as planned, and then tomorrow there’s a riot. How are you going to then be able to have participants coming through when that is happening? Or there’s a protest, right? How do you make sure that not only your staff is protected, but also your participants are protected? It’s very important to have, as I said, those community stakeholders that are really based in the community but also have an interest within the study group that you’re working with because they are able to give you an immense amount in terms of input.

Zandile, I’d like to turn the conversation back now to you personally. How did you end up in the field of community engagement in the first place?

Community engagement, I think for me, was sort of an organic process for me to be part of because I initially started out working — I think you would call it city council and in South Africa, we would call it local government. So, I worked in the city council for social development and social cohesion projects really focused on developing communities through sort of a public partnership approach. I worked for the Department of Public Participation, really making sure that, in processes or even some of the bylaws, we make sure that we have community input with that. So, as I said, it was really a gradual but organic way of moving into community engagement for clinical trials. My first clinical trial as a community liaising officer was for the Uhambo HIV vaccine trial, and I happened to have met one of the PIs during a public participation process and he was really interested in the way that we were working. He said, listen there’s an opportunity, please have a look at it. And I said, okay, that’s fantastic — I’ll definitely look at that. That was 2016, and as I say, the rest is history.

It sounds like you’ve always been involved professionally in the social sciences. What applications or principles of social science do you see in the community engagement space and how are they applied in community government, let’s say, versus a clinical trial?

I think we use sort of the same principles when it comes to public participation within community engagement in clinical trials. We use the same principles: trust, transparency, autonomy, and mutual understanding — and really having a collective buy-in with projects that we are working in. That’s one thing that I’ve seemed to notice. Within separate sectors, it would actually be the content that is different, right? But in terms of the strategies and the application, it’s still pretty much the same.

You mentioned another term earlier, GPP, or Good Participatory Practices. And that is one of the guiding principles for community engagement. Can you tell us more about that standard and why it’s important to apply GPP?

Yes. So, IAVI uses GPP as a framework for our community engagement. And we need to make sure that we are ensuring community engagement throughout the study lifecycle. Of course, we know that the process had started out in terms of really having standardized guidelines for HIV clinical trials, but it has definitely moved into other disease areas as well. So, we use this because we understand that community engagement can be fluid with regards to who’s doing it and where they’re doing it. And we wanted to make sure that we have a standardized way of ensuring that community engagement is first being conducted in an ethical way, but also that we are able to track.

Can you give an example of how you’re applying GPP to a specific trial that you’re working on now?

Currently in Liberia, we are doing the C102 trial, which is the Phase 1 trial for the Lassa fever vaccine. So, as they were recruiting and during everything in terms of accrual and getting participants and volunteers into the clinic, they then were able to find that some of them were not eligible for the trial. Now they needed to go back to the community advisory board and say, so how do we communicate this? Because this is a community that we had prepared, this is a community that had volunteered, and, also, this is a community that had given up their time and participated in the trial. They had that, and then also they asked the community, what information or value do you want to know around Lassa fever? So, in that case, the community was able to say, okay, even though we were not necessarily eligible for this trial, we were then able to gain some key information around Lassa fever, its management, its prevention — all of that simply because we had volunteered for the trial.

Thank you so much for that example. I want to talk a little bit more about Lassa fever. First of all, I would love for you to share more about what Lassa fever is and why IAVI’s developing a vaccine for it.

Lassa fever is a hemorrhagic fever virus that is wreaking epidemic in several countries of West Africa. And unfortunately, at this point in time, we don’t have a vaccine for it. So, we are currently working towards finding a vaccine in IAVI through a CEPI- funded clinical trial. We’ll be testing the Lassa fever vaccine candidates. They’ll be testing it in three West African countries, which is your Ghana, Liberia, and Nigeria.

How are you designing community engagement for each of these countries? Because each is different and has different attitudes and understandings towards clinical research, maybe Lassa fever itself.

Liberia is well-versed, I would say, for community engagement because of the experience that they’ve had with the Ebola trials. The Ghana site — the institution is in a university setting, so most of the community engagement is around outreach. So, that was really different with the Ghanian experience, and we’ve been able to really ask them and map out who and what is important in terms of really conducting this trial in an ethical manner. One of the things that we picked up was, because this trial is also going to involve children, pivotal in having children in the trial would, of course, be the parents. But also, you would want to look at teachers that work with children. You would want to look at what are the laws around working with children. Is there training that you need to have for the study sites? And they’ve noticed that because they say, we’ve never had a community advisory board. So, that was something they really appreciated from the engagement that they’ve had with us in terms of training and development around GPP framework. And then, of course, the Nigerian sites, they work with health mobilizers within the community. So, they have a constant ear in the community to engage and to inform the sites of any rumors, any misbeliefs, and really just any concerns that might not necessarily reach the team on time through the organized meetings.

That’s a really wide range and a pretty tall order for a clinical trial. So, how do you prepare each of these groups to make sure that not only does everyone fully understand the details of the trial, but also that their rights are protected and they’re fully informed of the potential risks and benefits of the research?

It really feels impossible until you start doing it. So, what we’ve done for the C105 trial is we’ve tried our best not to have a cut-and-paste sort of strategy across our study population. What we’ve done is to look at different engagement strategies for different populations. For instance, we looked at children and said, okay, what would work for children in terms of them also understanding why they’re in a trial? We understand, yes, the parents need to give the consent and the child gives consent. But what would work for them to understand what is going on? And one of the things that we thought about was having a speaking book, right? Very great material, engagement material, where the child can just open it and press the button and the book would speak about what’s going on and all of that. Another one would be around the adolescents where we said, yes, we can have homework classes so that when they do come in, there’s a benefit to them being there. With people living with HIV, working very closely with the representatives within these communities — so, our healthcare workers — they’ve been really engaging with the clinical research sites in terms of, how do you engage without causing any harm and stigma to the participants? I remember we had a conversation with the Ghanian site to that end. They have a beautiful, sort of a garden within the clinical research site. And we thought, we want to put a swing here! We want children just to be free when they come here and for them to be children, basically.

That’s amazing. I mean, it sounds like it’s very challenging to put together, but it also sounds like something that would be very rewarding when it does come together. What do you feel is most rewarding about your job in community engagement, Zandile?

I think it’s really creating the legacy of research within our communities. You know, going into a community that might be research naive or might have certain understandings around research. We’ve seen this with COVID-19 and vaccines, and I always used to say, sometimes it’s not necessarily that people are anti-vaxxers, but really people are not understanding what is a vaccine, what is the use of a vaccine. I remember, during the heart of COVID-19, being in the community and really explaining to mothers that when you go to the clinic with your child for immunization and all of that, this is a similar process, and it was like a light bulb. “Oh, nobody has explained that to me. I thought we’re just going and we’re getting this thing, and I don’t know why.” And we will really explain and try to understand how communities want to receive information. So, for me, that is really where the passion comes from — when you’re working with communities, then communities are even informing you. And one thing I always say is to not make assumptions. You don’t know. There’s an analogy that I always use — you can come there and you can say, I want to talk about coffee. And one person would say, well, what about milk? And the other person would say, well, what about the sugar? And the other one says, I don’t take sugar, but I do take a sugar substitute. So, how are you going to handle that there? It’s an ever-learning process. That process of building relationships, communities, and building that bridge between a community and a clinical research site for a research project.

Thank you so much, Zandile. I think that’s a beautiful note to wrap up on and I just want to thank you again. This has been a really wonderful Meet the Scientist experience, and I’m excited for everyone to hear more about the amazing work that you do.

Thank you, Rose. Thank you so much for the invitation. We really appreciate these opportunities for us to really share with everyone, share with the public, in terms of why this work is so important in clinical research. So, thank you so much.

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