Jackline Odihambo & Kagisho Baenyape, HVTN/CoVPN Africa Region

Leveraging on HIV vaccine expertise ‘Starting from basics where we are strong” 

Moderator: Tian Johnson

Complied by: Anna Matendawafa – with inputs from Wilfred Gurupira & Maaza Seyoum

Queries?: info@africanalliance.org.za

Webinar Recordings & Supplementary Materials

www.africanalliance.org.za

www.thevarg.org

Date: 23 July 2020

https://www.clinicaltrials.gov/ct2/show/NCT04431414https://www.hptn.org/sites/default/files/inline-files/Protocol%20Version%201.pdf

WHO 

Dr. Jackline Odihambo 

Dr. Jackline has held various roles in the public health and clinical research quality/management arenas, including treatment, prevention, and vaccine infectious disease clinical trials in the region. She currently serves an integrative role supporting project operational oversight with the HVTN/CoVPN Africa Programmes Directorship. 

Kagisho Baepanye 

Has a background in nursing, primarily as a chronic nurse doing education in the medical wards of Klerksdorp/Tshepong Hospital. Later, he started recruiting and educating TB research and then continued his clinical trials to work as a Community Engagement Manager overseeing community engagement for HIV/TB studies and HIV testing programs of his former site. He is currently the Community Engagement Project Manager for HVTN/CoVPN Africa region. 

HVTN/CoVPN

The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating vaccines’ development to prevent HIV/AIDS. The HVTN conducts all clinical trial phases, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy. It is a founding member of the COVID-19 Prevention Network (CoVPN) formed to respond to the global pandemic.The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases(NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and international partners, NIAID has directed the networks to address the pressing need for vaccines and monoclonal antibodies against SARS-CoV-2. This includes the: HIV Prevention Trial Network (HPTN), HIV Vaccine Trial Network ( HVTN),Infectious Disease Clinical Research Consortium ( IDCRC), AIDS Clinical Trial Group ( ACTG)  

WHAT 

Observational studies: HVTN 405 / HPTN 1901This study will enroll adults who had a positive test for SARS-CoV-2. It can include people who developed Covid-19 illness and people who did not show any symptoms. This study’s main purpose is to learn more about SARS-CoV-2 infection and how our bodies respond to and recover from it. CoVPN 5001 This study will enroll adults who have had a positive test for SARS-CoV-2, those who do not show any symptoms, those showing mild symptoms, and those showing severe symptoms. This study’s main purpose is to learn more about the immune system during early infection with the virus. The study will help us understand how the body fights COVID-19 infection, and this information could be used to evaluate whether future COVID-19 vaccines candidates work.  

WHEN

HVTN 405 / HPTN 1901 ( Not yet enrolling ) CoVPN 5001 Start Date- July 20, 2020 Estimated primary completion date – January 2021 

WHERE Recruiting 

  • Tongaat CRS, Tongaat 
  • Verulam CRS        
  • Chatsworth CRS, Chatsworth 
  • Botha’s Hill CRS, Durban 
  • CAPRISA eThekwini CRS, Durban 
  • Isipingo CRS, Isipingo 

Not yet recruiting

  • Groote Schuur HIV CRS, Cape Town 
  • Khayelitsha CRS / (CIDRI UCT), Cape Town
  • Masiphumelele Clinical Research Site (MASI) CRS, Cape Town 
  • Ndlovu Research Centre CoVPN CRS, Elandsdoorn 
  • Vulindlela CRS, Durban 
  • Kliptown, Soweto CRS, Johannesburg
  • Soweto HVTN CRS, Johannesburg 
  • Aurum Institute Klerksdorp CRS, Klerksdorp
  • Qhakaza Mbokodo Research Clinic CRS, Ladysmith
  • MeCRU CRS, Mendusa 
  • Nelson Mandela Academic Research Unit CRS, Mthatha 
  • Rustenburg CRS, Rustenburg
  • Setshaba Research Centre CRS, Soshanguve 
  • Tembisa Clinic 4 CoVPN CRS, Tembisa 

WHY

To conduct Phase III efficacy studies to prevent infection and Covid-19 diseases.   

HOW

CoVPN 5001 The study will include 3 groups, as described in the table below. Groups are defined based on clinical status at enrollment, but for data analysis purposes, participants who experience disease progression can contribute data to other cohorts.Participants will complete six visits over 28 days, followed by a health contact at Month 2 (one month after the last scheduled visit). Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.Study visits may include reviewing medical history; interviews/questionnaires; pregnancy tests (for participants assigned female sex at birth); blood draws; nasal swab, nasal wash, saliva sample collection, and optional stool sample collection. 

QUESTIONS AND ANSWERS 

*This section contains a transcribed account of the Question and Answer Session

TRIAL SPECIFICATIONS Will you be recruiting people who are COVID positive individuals or people with COVID for the study?

When you go back to that slide it says the study will enroll for example for 405 HPTN 1901. The study will enroll adults who have had a positive test for SARS-CoV-2 this can include people who have developed COVID-19 illness, people who remain asymptomatic  and when you look at the CoVPN 5001, I said the study will enroll others who had a positive test for SARS-CoV-2 , those showing no symptoms and those showing mild symptoms or those showing severe symptoms. So people, for both these observational trials it’s for people who have been diagnosed with a positive test for SARS-CoV-2.

How do we handle evolving information as it comes? Today we are told all confirmed cases can transmit the virus the next day we are told only those who are asymptomatic can transmit. And so with this new information and, I guess this is not a question specific to COVPN or HVTN, I think it’s a struggle that we have across the world really, in terms of this tsunami of information and rapidly changing information constantly.


I think Tian, you know when you ask what your, you ask what our personal is or what we have learnt. One thing I have said is things are not going to be the same and need to continue to learn. So the way we convey our messages today of what science has shown us we need to ensure that we convey it in such a way that we would be able to add additional information as it comes. Because with COVID-19 we, as we educate or as we disseminate information, we can’t disseminate it as a final. Whereas currently you mention a tsunami of research and all that whereas information is still coming. We need to ensure and remind communities that we are still learning about COVID-19 and we will continue to learn, be prepared for new information as it comes. I think that will make; it will also help us to make communities to always be ready for new information as its coming. Because Professor Grey was speaking in the morning and you also hear , we heard that recently UN is still, I mean WHO is still , has received information that the spread of COVID might be air borne and they said that they have noted that. And that message can be received by people on the ground and so we need to make sure we make our communities ready for new information as we give currently what we know about COVID-19. You know, just, even outside the context of clinical trials of COVPN or research everyday there is new information in general, so that you need to process and using your everyday activities. But, yaaah so we are on the science and we are used to looking at information and adapting to it as necessary so and that’s normal practice for us.


What is the relationship between COVPN and pharmaceuticals companies as research rolls out? If you should describe that relationship in the South African context.


So, a COVPN is more of a coordinating centre – right. Our most immediate efforts revolve around coordination of clinical trials making sure that they are scientifically rigorous and that communities trust it to be safe. I mean pharmaceutical companies do a lot of development of the investigation of products and so in a nutshell that’s how this looks. 

So at this stage for COVPN-5001 there is no existing relationship or agreement with pharma companies in terms of the research that will roll out in South Africa.

No that’s an observational study, there isn’t. Just our own practice run, I should say.                         

BROADER STAKEHOLDER ENGAGEMENT Could you speak in terms of the research that will happen in South Africa? What do you view as the role of communities in this research beyond Community Advisory Boards(CABS)? What is your approach to engagement beyond CABS structure, or at this time, is it limited to the CABS? 

Yeah, I was struggling, Tian, please unmute us. I want to speak to that. So one of the things I will start first by saying when you look at the GPP. GPP encourages us to not focus on CABS but to do broader stakeholder engagement. And that is what currently sites are doing. They’re not necessarily engaging CABS within they’re only in catchment areas, but they’re also broadening their engagement beyond CABS. So that is what currently sites are doing. And this is something that we are also continuing to encourage sites to do. To say we are going to work with community advisory boards. However, other stakeholders, places, and COVID are also opening new avenues to work with other stakeholders that we have never worked with before, like people who work within senior citizens. So, it is our recommendation and sites. I’ve been implementing it to work with CABS and beyond to include its broader stakeholder.
 Yeah, that pandemic is, you know, I mean, obviously, by being a pandemic is global. And, you know, it’s brought a situation where there are expedited timeframes with everything. And so, the CoVPN is relying on its extensive community engagement, experience, and long-term relationships with communities over the last 20 or so years. So, we are we’re happy to work with everyone and manage expectations and concerns. Such platforms like this are also helpful to hear what maybe some of the questions or concerns?

Do you feel that there is a role in different approaches in terms of engagement and not regard existing HIV structures and engagement platforms as given when it comes to COVID?


I’m not sure I understand. The question, but I would say, if I understand you correctly, if I understand you, but as I said, I think maybe I should ask you to repeat it. 

Do you think there’s a need for different relationships, groups, CABS that do not come from the legacy of HIV research? So, I’m asking, do you think we should be very clear about how we split to these two issues, and not rely on existing or historical HIV networks and partnerships to leverage new COVID work? And I’m merely asking you in terms of time and resources and community effort and energy and all of the different resources we put into its engagement. 


To precisely what you have just said now, I mean the previous HIV work already has resources,  already has people on the ground because of time and resources. So, as much as we want to move faster, we need to leverage what we already have used. That is what scientists are doing. They are leveraging the existing resources. So, I think that is something that we attempt to implement to see we already have people on the ground and communities. Let us start from there. Going back to what we said earlier, the best thing we could do is increase the engagement we already have, adding more stakeholders and civil society. We discuss new pathways, new avenues that we can all together pursue to ensure that we disseminate direct information to the correct sources for COVID-19. So, I would say we need to start from the basics where we have always been strong. Yeah, I’ve been able to unmute myself, but regarding the previous question about CABS. I agree that the issues are separate COVID  and HIV, and we need to perhaps learn from the HIV network lessons. They have experienced that we can learn from I’m not saying use the same people necessarily. However, you know, leverage their expertise and experience over the years in engaging communities and understand how best to respond. So, these are trusted relationships that will build over time. And it would be helpful to rely on some of these existing structures, just like raising the footprint of sites that have experience in conducting infectious disease trials. Yeah. 

How will equitable community engagement be ensured during the COVID-19 pandemic where traditional engagement practice is not possible, it is vital that we facilitate equitable engagement to ensure that marginalised communities are not further left behind, communities are not equal with others more resourced a one size fits all approach cannot be the way to go communities should lead and this will to ownership.How do we ensure that stakeholders are resourced to participate in zoom community engagement meetings?


Thank you also for that question. As I said, already sites have experienced that other people have resources, and others have no resources. However, the most important thing because we cannot let people get behind because of a lack of resources. And communities, sites have always ensured that to reach out to those people, too, because you can’t leave your stakeholders behind, irrespective of whether they could access data because we know that data is expensive like I’ve mentioned. So, it’s not everyone who has it because, for example, other people may not be having smartphones like everyone else. So, you can leave those people behind too. There has to be ways and to maneuver new ways to ensure that people are informed, and we make sure that the engagement is repeatable across the spectrum, not only for individuals that can afford


Is there any specific approach that you take to engage communities of faith in understanding the reason for your existence in the country, the research you do in the country, and the support and solidarity that ultimately you seek to secure from communities. In this case, specifically faith-based communities.


In terms of faith-based communities, I would say that community educators have always been engaging in faith-based communities. I think that experience is there. And we, I would say we are fortunate to have faith-based organizations that are still willing to participate and get involved in things involving communities. I think that this is one thing that I don’t feel is left behind. One of the things that I’m not sure whether its intervention is common to a division, but that organizations are not currently meeting with their members regularly as the norm in most respects. However, a faith-based organization they have always been part of the people that we are still engaging and that is one thing that will also increase to ensure that we continue to reach out to them even further. As I said before, this is the time for us to improve how we have been engaging with various communities. 


One of the factors driving higher rates of infection in our country stigmatization of the pandemic, in that people who test positive don’t even tell the members of their own families. How do we destigmatize the epidemic so that people who are infected can even participate in research? And I guess the more pointed question would be around what work you are doing to address the issue of stigmatization in your communications materials and your outreaches. What support do communities have, whether they’re part of a trial or not, to lean on you for that kind of help when it comes to the stigma attached to COVID-19?

One of the other things that I mentioned in the slide is that we are currently doing education on COVID-19, not necessarily site-specific, because they have not received approval from ethics. So that is part of ensuring that we eliminate stigma before you can bring any like study-related information; for example, we need to make sure that in people and communities understand what the COVID-19 is and destigmatize it because otherwise, those people who are infected or who might have been affected, they would not even come out. But the more we ensure the right information is put out there to ensure that people stop destigmatizing COVID-19. It’s one of the first things a country needs to be doing, so I think that is one of the first things that we could do and cut the distance to ensure that we’re destigmatizing the issue of stigma is going to be a stumbling block moving forward. After all, it’s already a stumbling block currently like; you mentioned that people who are infected sometimes don’t even inform their own families. That is the reality of what is currently happening.
Yeah, I agree with Kagisho, and we also rely on other avenues such as the news media or social media. So this also helps to amplify a lot of the efforts that we make. So, you know, at least in terms of access to information, the radio would be essential as an avenue to talk to communities. And that also caters to, you know, the need for physical distancing. The other thing we are doing it is, you know, supporting the sites and the staff to understand COVID-19 is a preventable disease. What you can do yourself to prevent it, and even when you have it, this is what it means, and it’s not anything to be fearful of, or should I say, to have a stigma? We are trying to support the messaging sites that amongst themselves, with participants and communities, make sense.
The other thing that I should also mention  Tian is that community educators are already involved with the local radio in their locality, where they are part of the efforts to destigmatize COVID-19. They’re working with other stakeholders on the ground who are doing education. So community educators are participating in local radios, talking primarily on COVID-19 and educating communities.

ANTI-RESEARCH / ANTI- VEXA SENTIMENTS Could you give an overview of either Kagisho or Jackline on what work you are doing within the country to address the tide of anti-vaxxer, anti-research sentiment? You know, a few weeks ago, we saw an anti-vaxxer march that took place outside Wits around the Oxford vaccine trial. It did receive some coverage, but it also feeds into this broader narrative of anti-vaxxers and anti-research anti-science supported by many powerful and influential people. And so what does a structure a network like the HVTN or now the CoVPN? And how do you respond to that kind of wave in this context without feeding into the misinformation?


Thanks. So, I don’t know whether we react to it per se as a network or as a team. We continue to do on our end to engage and educate or let me say, educate and inform such continuous efforts on education about some of these diseases, SARS-COV-2 how to protect yourself, what are clinical trials and studies? How do vaccines work? So those kinds of informative or education also, messages are some of the things we focus on to do our best to continue to inform and educate communities and people. I don’t know Kagisho; you want to add anything to that. Yeah. Suppose you take the experience from HIV vaccine research, and what happened with the past, how people used to be hostile towards anything related to HIV. In that case, I mean sites, communities on the ground, where education took place. We won the battle. When communities on the ground are informed, they can make better decisions, even irrespective of whether influential people are hostile towards the work that will be done. And even with HIV, if you could remember influential people who were very negative, people informed the communities on the ground and managed to make informed decisions. So, we emphasize continued education and education because the more communities are aware, I told them more than able to rise and respond in the fight against COVID. We will continue to see and have such negative sentiments that we have seen. However, when people are informed, they will be able to make an informed decision. We need to ensure people are mobilized on the ground and advised and have the correct information about what is happening on COVID-19. Thank you for that. We are also just basing our information on evidence and science. One of the things we do is direct people to correct information sources or credible sources of information. That happened in the past with other vaccines and shown to work Polio, Tetanus, and others. So, and I think another rule will be on the end advocates to make sure that we coordinate the trials in the right way and the communities’ interests at large so. 

As a collective, do you think more can be done to address this tsunami of misinformation, anti-vaxxer beyond providing information? I imagine your sites are highly localized, and I’m not sure if you can claim to have a national footprint? In terms of a national footprint, is there a recognition at the network level that issues around anti-vaxxers and anti-research and anti-science movements need to be addressed as a broader collective, not only for the work of  HVTN and CoVPN but also for the broader research community? For example, we know that the march that took place outside one of the Oxford’s office sites at Wits. We recognize that as advocates, that march was not only an issue around the Oxford trial. That march had the potential and indeed still has the potential to derail research, in general, to derail science, in general, to take us back many, many years. Do you think there’s anything more that we can do as a collective with the network to ensure that anti-vaxxer sentiment, anti-research sentiment anti-science opinion is more clearly addressed beyond engagement and direction to information and resources?

Yeah, I agree, Tian, and most definitely. You know, groups or authorities, such as the Department of Health, have a role to play in this. And as well as well-versed advocacy groups are needed to help in this messaging. So yes, I do agree. Yeah. The other thing I wanted to say, Tian is that more is always good, there’s still room to ensure that we can improve, and the other thing is that as much as the march, I agree with you that it could affect the research work itself. As much as the march received, how can I say,  attention nationally? We also need not forget people on the ground and continue doing things parallel at the national as advocates as you suggested and continue on the ground because we do them parallel. It could significantly impact our fight against these myths and misinformation about COVID-19 and research in general. 

REFLECTIONS We know we’ve learned dozens, if not hundreds of lessons when it comes to engagement from HIV and mistakes that we hopefully shouldn’t repeat. So I think I might put both of you on the spot and ask both Jackline and Kagisho, could you share your reflections on what in your mind is one of the biggest lessons that you take from your work in HIV into the COVID space, specifically around what we perhaps should not do? But feel free as well to share what we absolutely should do. What do you take from your years in the HIV field in terms of lessons learned around engagement?


Oh, firstly, Tian, things will never be the same. And we cannot think that we would engage with communities the same way as we used to. And we need to how our work has increased more. Because we are facing a pandemic, which is anonymous information is changing every day. So, we need to be running and be on speed and ensure that our communities are informed. But things are not going to be the same. And we cannot be communicating the same way as we used to, but we need to work harder. Keep watching, keep learning, and ensure that our communities continue to learn, but things will not be the same anymore.
Yeah. So, I think for me and to put one of my colleagues who works with the communities is without community support, we can’t move forward, science can’t move on. So, we need the communities always to be able to do a lot of these things that we do. We can’t respond appropriately or adequately to any, whether it’s a pandemic,  epidemic, whatever it is, without their help, should I say. So meaningful engagement with communities is a plus. It is always a plus.  

How, in your view, do we present research as a solution to health issues in South Africa. Within the context of racial polarization, I think this feeds into the global movement and a national pulse of this evident polarization in terms of racial polarization in this country. As you work and conduct your research, intending to present solutions to health issues, how does race factor into this? Is it a factor in the discussions internally with communities. Do you regard race as an issue in your research?

 Thank you. I would say our community educators. We have been working with them in research, for example, for HIV. There are issues of engaging communities that are not involved, either your white or Indian community, or you can name any other gathering you can think. We have always said it’s essential to engage various communities within the group that we are engaging in. And even if you might not have them currently, you need to ensure you need to keep on reaching out. There are other sites I remember what they were doing. They participated in engagement activities in communities and, for example, in white communities when they wanted to involve that community in running races to reach out to those communities. So, it is one of the things that various sites are working on. It’s something that has never been left behind. It will always be that we don’t have this group of people within our engagement, and we would try to reach out to them. And one thing that we want amongst the many things that we have learned about COVID-19 is that it’s been cutting across whether you are, it doesn’t matter where you are. Hence, I will repeat what I said, and the challenge that we are facing of COVID-19 is pushing us even to go further and work for more challenging enriching communities. Even communities, we think we have not been participating, or we have not reached out to them. So, we need to reach out to any other place that we never thought we have not reached out too. So, it’s time to move beyond perhaps if we see the comfort zone, but move beyond what we have been in a view beyond committees that we’ve been teaching.Yeah. I agree with my colleagues, who saw the children just need to be inclusive of the people who stand to benefit the most. And that’s true for any research. So, you know, it wouldn’t be fair to find that our product works in setting groups and would not sound the populations. Who are, I would say, the hardest hit by, in this case, the COVID pandemic. So yeah, we are committed to that. Yeah.  

Could we share one reflection with a quick review from both of you? 

Um, I would say that we are partners with communities; we need the communities to do our work. And then give back to the community the solutions to a lot of these issues. That would be my take-home message that we are partners in these ventures. And just to go back to two studies that Kagisho mentioned,  405 study and  5001 are starting soon. If anyone wants information, get in touch with  Kagisho or anyone at HVTN, CoVPN here. Or even the nearest site for more details, so yeah, thanks for your time this morning. It was a pleasure talking to you and hearing the questions you have. Thanks.
I just wanted to say Tian, thanks for the opportunity and audience for participating in this call. I wish to say to the civil society and everyone here that it doesn’t matter how good the science is, but it won’t matter as long as it does not make sense to communities. Because science as it comes, how big or how great it is, but your committees don’t understand it, it wouldn’t make an impact. So, we need to work together to ensure that our committees know that it can move forward. Science will never move forward without the involvement of the communities. And we are committed to providing that we work with communities, and we manage to be where we are as a group because of our relationship with communities. And they are the heartbeat of the work that we do. So, we appreciate the commitment of communities. And we’ll continue to invest in immense ourselves in our communities, and we appreciate what you have done today, and we believe that this is the first of the many conversation and calls with you. Thank you.

UNANSWERED QUESTIONS: 

Morning, my question will be in terms of prevention education as now COVID 19 is confirmed to be airborne, are the prevention measures we have enough? May you share the SA Community Engagement plan that focuses on National stakeholders’ groups, NGOs named so that at provincial and site level, we align with similar external holders. How may we support all COVID-19 and HIV research in SA including CROWN, network funded etc as a collective in a collaborative way. Communities and advocates are one thus we need to display this with National Stakeholder groups, a National CAB etc.  The goal of HVTN 405 observational study is to learn from infected persons. Have we engaged the current people infected as part of formative research using shared stories on social media platforms? What are the plans for them to be engaged in CABs, Civil society and other groups using their experiences?