Charles Ryan: Hello. Today, we're having another conversation on the Pfizer Global Health Equity Challenge Award series. I'm delighted to be joined by Dr. Veda Giri, who is the Chief of the Division of Cancer Genetics at the Yale School of Medicine and Assistant Director of the Clinical Cancer Genetics program at the Yale Cancer Center.

Dr. Giri, Veda, great to see you. Congratulations on your move. Sounds very exciting. I'd love to talk with you a little bit about that, but we're going to talk about your Global Health Equity Challenge Award first. Thank you for joining us and look forward to your presentation. We'll converse on the other side.

Veda Giri: Thank you so much for having me. I am thrilled to be here and excited to share about this project that we have. We're so grateful for funding for this project. As I mentioned, we're very, very excited about this project that we have called the EXPAND Network, which stands for Extending Prostate Cancer Genetic Awareness, Navigation, and Delivery for genetic testing, genetic awareness in males of African descent for Black men.

This is funded by the 2021 Pfizer PCF Challenge Award. We're very grateful for this funding. I just wanted to set the stage and just give a few slides here on background that led to the rationale for our project. These are recent statistics from the American Cancer Society, and they're focused in the burden of prostate cancer in Black men in the United States.

This has been consistently shown that prostate cancer will be the number one cancer diagnosed in Black men in the United States, as well as the second leading cause of cancer related deaths in Black men in the United States.

Importantly though, is when we look at the comparisons between Black men and non-Hispanic White men. What we do see here is higher rates of actually developing prostate cancer for Black men, as well as very importantly, higher rates of dying from prostate cancer.

This really becomes important because there have been many advances in the screening and diagnosis, and particularly in treatment of prostate cancer over the recent years. This is a slide that I had shown at the recent American Society of Clinical Oncology meeting, a very simplified schematic going all the way from prostate cancer screening and risk assessment to the management of localized prostate cancer to, on the other side of the spectrum, treatment of metastatic castration resistant prostate cancer.

Germline testing or genetic testing, hereditary cancer testing for prostate cancer has now become central across the spectrum of care for prostate cancer. It's increasingly informing treatment in the metastatic setting as we know, with targeted therapies dependent upon finding of specific genetic mutations, particularly in DNA repair genes, an evolving role in localized disease management.

We look forward to more studies about how to manage localized or low risk prostate cancer based on genetic information. Then, also on the screening side, there are now screening recommendations, for example, for male, BRCA carriers, particularly BRCA2 carriers to begin prostate cancer screening at a younger age.

Across the spectrum, there are genetically informed clinical trials that are going on. This field will continue to advance. Then, important from a population perspective, is this is hereditary cancer testing.

We can identify hereditary cancer syndromes in these families of men who undergo genetic testing and potentially have a genetic mutation identified. Some of these syndromes are shown here, hereditary breast and ovarian cancer, Lynch syndrome, hereditary prostate cancer.

Thus, there can be cancer risks that are uncovered, and that could be important for management for males and females in these families. Again, pointing to a population level impact.

Then, this is a summary of NCCN guidelines that are addressing germline testing for prostate cancer, where there is a recommendation to offer germline testing to all men with metastatic prostate cancer, high risk features, or very high risk features, certainly those that have a germline mutation in their families.

Then also, family history that points to suspicion for hereditary cancer syndrome for hereditary breast and ovarian cancer, cancer suspicious for Lynch syndrome and features of hereditary prostate cancer.

Now, to be able to engage, therefore, in the genetic evaluation process and to get the benefits of targeted treatments in the metastatic setting or tailored cancer screening, we have to be able to engage our populations in this genetic evaluation process.

This is a multi-step process. This is one of the most classical ways to think about this, where a patient is referred to genetic counseling. They make an appointment with the genetic counselor. Family history intake is conducted.

There was pre-test genetic counseling where multiple elements of informed consent are discussed. The provider or genetic counselor then orders the appropriate genetic test. Then, results are given back to patients about treatment for their prostate cancer, management of cancer risks, and hereditary cancer testing.

This is also being conducted now, of course, not only through genetic counselors, but also from a point of care fashion, so by healthcare providers themselves. What's important to note is that when we look in total at many of the studies that have uncovered genetic mutations or have led to these breakthroughs in advances, really these studies in clinical cohorts only included 10 to 15% African-American participation or participation of Black men.

What we have is a gap in knowledge, as far as what are some of the most important genetic mutations to think about in Black men? How do we engage more Black men in this process and to come up with strategies for equity?

In our research program, we have multiple studies that are going on that address disparities in equity, access, dissemination, and population needs. Those are laid out here.

What I'd like to show is I'd like to give thanks to the Prostate Cancer Foundation, because we have received funding that address multiple aspects of access to genetic testing and prostate cancer and disparities as is shown here. The grant that I'd like to talk about today is the EXPAND Network.

This follows in a line of work that we've been doing, looking at peer based approaches. As you can see here, two of these grants have been funded by the Department of Defense. This is now the EXPAND Network that we'll be talking about, which is funded by the recent Pfizer PCF Award.

Why are we thinking about what does it mean to think about peer based approaches? One of the things to think about is that peer navigation has been used, which is basically navigation assistance by a peer, a patient's peer, somebody that a patient identifies with as similar to them, either in upbringing, in background, in career, either by sociodemographic characteristics, et cetera.

Peer navigation has been used to access so-called hard to reach populations or groups, those that have been under engaged in various aspects of either healthcare or clinical research. Those four basic elements of peers, like I mentioned, they share specific and common characteristics. They share qualities that increase the effectiveness of the services that they provide.

These peer educators, navigators are trained to deliver specific interventions, and they are really engaged with the study team and engage in executing the standard protocols that we have here.

Peer navigators have the potential to increase uptake and adherence to many healthcare practices and have been used across various different settings, such as in HIV compliance and medications, smoking cessation. We wanted to adapt to this model in this space of engagement in genetic evaluation for prostate cancer.

We also have the ability to address complex emotional and social issues really come into the community setting for this type of work to address the diverse healthcare needs and increase the ability for patients to make a decision about, in this case, for genetic testing.

This is on a spectrum, as I mentioned. We have two other projects that are going on that are looking at men at risk for prostate cancer in the community setting. This is looking at peer educators. We have another study that is going on in the actual healthcare system, looking at engaging men with prostate cancer in genetic evaluation, through peer navigation.

Then, this is our EXPAND study, which is looking at in the global setting, across various cities to build a network of peer genetic coaches. This is the EXPAND Network. This particular study is, as I mentioned, funded by the Pfizer PCF Challenge Award. This is our study team. I'm very excited to work with all of these experts for this project.

I myself am the Principal Investigator for this project. My co-principal investigator is Dr. Amy Leader, who is a population scientist. She's the Associate Director for Community Outreach and Engagement at Sidney Kimmel Cancer Center at Jefferson.

Then, our co-investigators are Dr. Mary-Ellen Taplin from Dana Farber Cancer Institute, and then Dr. Brandon Mahal at the University of Miami. This was exciting because we were able to engage multiple cities across the Eastern seaboard all the way down into Miami.

We are able to engage Boston, New Haven area with my upcoming move to the new Haven area, Philadelphia, and Miami. Diverse regions are represented in this particular projects. We actually plan to extend this across major urban areas or areas of, to enhance engagement of Black men across regions of the United States.

Our overall objective with the EXPAND Network is to develop and assess a national network of African American men as peer genetic coaches, to help African American men navigate this prostate cancer, genetic counseling and testing process for greater engagement in precision medicine and tailored cancer screening.

It's a three step model where we're going to train African American males as peer genetic coaches, and we're going to engage them across these various cities. As I mentioned, Boston, new Haven, Philadelphia, Miami, and other regions, as we expand our study. We're going to also then, so we're going to train these guys to be integral parts of the study team.

We'll also then develop the infrastructure competently with the training of the peer coaches, convening a stakeholder panel and a community think tank to really think through how can we increase awareness, outreach, and engagement of African American men across these cities, build an academic to community collaboration and partnership, and develop and disseminate a strategic plan out of this. Really, we can put this out there for others to potentially follow and to help build engagement for this project.

Then, we're conducting a pilot feasibility study to actually provide individual coaching for African American men in the community. We proposed that we would coach 50 men with a centralized process of these trained African American peer genetic coaches.

We're going to assess process in patient related outcomes. We plan to publish the results of the pilot study, but really also have this power and national initiative to help engage more African American men in the prostate cancer genetic evaluation process.

I won't run through this, but this is basically how the peer genetic coaches will engage with our patients and participants on this study. Through study related processes, the peer genetic coaching steps as can be seen here, they're going to help them learn about the study, connect with the genetic counseling program, address any challenges, barriers, hesitation that they may have with engagement, and then connect them back with their doctors regarding their genetic test results, and then be able to follow up with them for the patient reported outcomes that we're interested in assessing.

Overall, we hope that this project, the EXPAND Network, will really make an impact on engaging more African American males in the genetic evaluation process. As far as to our knowledge, this is the first national peer based initiative to help address disparities in prostate cancer, genetic testing in particular.

We have diverse regions of the United States represented and we plan to expand to include other sites as well. We're very excited about this strategic plan that we're planning to develop and disseminate with engagement of the community and academics, as well as including, of course, patient advocates, et cetera.

Then, we hope to really create a sustainable model going forward to engage more African American men nationally and globally in this effort. We're very grateful for the 2021 Pfizer PCF Challenge Award to make this effort possible. Thank you.

Charles Ryan: Well, thank you and for the great presentation, outstanding ideas and work, and a really great project. A Question, how are you going to find individuals to become the peer coaches? Where are you were going to recruit them from?

Veda Giri: Yes, and this was a very important point as to why we needed to engage our collaborators at the various institutions. Each of these collaborators, Dr. Mary-Ellen Taplin, Dr. Brandon Mahal, Dr. Amy Leader, all have major presence in their communities. They actually already have networks that are set up. This is how we're going to engage African American males to become peer coaches for this  study.

Charles Ryan: These will be patients perhaps of the physicians who are your collaborators, and maybe individuals who are involved in support groups or other-

Veda Giri: Exactly, exactly, and who are motivated to do this, and also who have their own community connections so that they can be the liaisons and build working with the community engagement.

Charles Ryan: Right. Of all of the metrics of success that you look at for this project, what is the one that will be the key driver for you to say, "We're on the right track, we're doing the right thing here?"

Veda Giri: I think some of the ones that we're looking for, we have sort two groups of metrics, so process metrics, and then patient satisfaction or outcomes types metrics. We're going to look at them both. From a process metrics standpoint, if we can achieve at least over 75% engagement from the calls that... We're going to create a central website, phone number, et cetera. 75% engagement in going forward with the process, with the peer coaching.

Then, we'll determine if there's drop off or anything like that for each step of the way. We would deem that this is a successful measure to expand upon. Also, from the patient reported outcome side. Some of the measures that are very important that we're going to look at is decisional conflict for going forward with the process.

Not everyone has to have genetic testing, but do they feel that they are comfortable in their decision making about testing? Decisional conflict and patient satisfaction. Do they feel that their needs are addressed? If we look at those two measures, we really want to make sure that we score highly on those.

Charles Ryan: Excellent. Excellent. Tell us a little bit about where you are in the process now. Are you launching? You're in the process of moving. Do we have the process ready to go? Are we recruiting? Where are you with all that?

Veda Giri: Yeah. We have been going through, of course, this is a study. We had to go through all of the ethical and IRB regulations and approvals. We have that. We're ready to go from that standpoint. The funding will be released actually coming up very soon here.

Exactly as to your point, I will be moving to the New Haven area to Yale. What we plan to do is actually execute the study centrally from New Haven, from Yale. Already, we've got all of these study sites engaged.

We actually plan to roll forward with training. Identification is already happening for who could be peer coaches. We'll start our training of the coaches here in the fall. We're very, very excited about this. We're also putting plans into place for the think tank to begin.

Charles Ryan: Are you going to do the training? Are you going to have the in person component to the training or is it all virtual?

Veda Giri: This will be done all virtually. The nice thing about it is that we have the track record of how to do these virtual trainings from our other peer based studies. We have a lot of the infrastructure materials already in place.

Now, this would be a two way street. We want to hear from our coaches about their specific communities. What do they find? What do we need to address? That'll also be incorporated.

Charles Ryan: That's great. Let's fast forward three, four, five years. We're talking again, and this has been an enormous success and you're going to build on it. What's your next step?

Veda Giri: What I envision already is that this pilot project is successful based on the various metrics. In the meantime, we've been able to engage multiple studies across the United States, Midwest, Western U.S, Southern U.S, but also globally.

I think that that is really where I would like to see this headed, is to actually have a global network of peer genetic coaches who can actually work with their communities, work with the healthcare systems, work with the doctors integrally as part of the care team.

Of course, this will take resources. Our data that we can provide really will be critical to help expand and disseminate this type of a model and have this be workable.

Ideally, also, this should be sustained whether it's through, if it can come to insurance coverage or not, who knows, but at the same time we have to start building the mechanisms for this.

Charles Ryan: Well, perhaps we can work together on thinking about the sustainability of this and the ways in which not only are you going to reach into the lives of so many Black men with prostate cancer and their families today, but over the course of the next year, years, and even into the next generations.

I think there's going to be a sustainable solution to that. We're really proud to sponsor this project and really looking forward to hearing of great results. Thank you for your time today. I'll be sure to check in as we go.

Veda Giri: Thank you so much. Again, we are so grateful for the funding. Thanks for the opportunity to give an update on the project.