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Updates: Self collection for HPV testing
Updates: Self collection for HPV testing
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Video Transcription
So thank you so much for the invitation to come to this amazing group. And I don't have any clinical experience. So it's been really fascinating to hear you talking about these cases in pre-invasive disease in the real world. We think about this stuff all the time and yet never in these conversations talking about the actual disease and management of them. So thank you so much. I'm a behavioral epidemiologist and implementation scientist. And so my work is really around how we implement usual care, standard of care and improve it in real world settings. And then how do we incorporate innovations in cancer prevention also in real world settings so that we can improve access. And a lot of my work has been around self-collection for human papillomavirus testing as a way to really expand access to cervical cancer screening, both globally and also a lot of my work in the United States. So let's see, why is this not advancing? Oh, okay. I don't have any disclosures. So our friend and our foe HPV, and I say friends sometimes because it gave us a nice hit that we can actually work toward preventing through the vaccine. The discovery of HPV, of course, allowed us to have a vaccine against HPV. And then also now really giving us precision tools for screening. And so because of this discovery and of the role of HPV in cervical cancer and other HPV associated cancers, we've really seen shifting paradigms away from visual methods, including visual inspection with acetic acid and cytology toward this precision screening where we test for DNA or RNA of human papillomavirus. And this is, of course, WHO's recommendation is that we screen using a high precision test for HPV and really do away with these methods of visual screening as well as combined methods that include visual methods like cytology with HPV co-testing. In the US, we've seen this in the guidelines. In 2020, the American Cancer Society really stressed that it's acceptable to do cytology, but it's really preferred that we do HPV testing. And there are rumors that future guidelines will do away with cytology and co-testing altogether and really focus on precision HPV testing. So as everybody is probably hearing a lot of, with the reason for the World Health Organization's recommendation and inclusion in the 90-70-90 guidelines for cervical cancer elimination is that HPV testing is superior to cytology and also other forms of visual screening such as BIA in that it has improved sensitivity for detecting SYN3 by about 50% over cytology. It has a high negative predictive values, which means that we can reassure persons who have a negative high-risk HPV test that they, in fact, are negative and have low risk for cervix cancer and can go home and just come back at their next screening interval. The cost effectiveness has been proven and it's a much better test in terms of cost. And then of course, what we are really excited about, especially in the United States where I'll talk about, we just had FDA approval, is that primary HPV testing can be done on self-collected samples just as well as it can be done on provider-collected samples. And because of that ability to be collected by women and other persons with a cervix themselves, we really have improved access to screening. So part of this paradigm shift is really not necessarily doing away with our VIA and our Pap test cytology altogether, but rather using those resources for tests that are conducted by a provider for those who have higher risk of disease. And so we can actually take the screening population and test them with primary HPV. And then based on those primary HPV results, we can then use our limited resources either for cytology or VIA or send that person straight to colposcopy. So not doing away completely with those visual methods, but rather really reserving those methods that require a provider to really focus on those who are positive for the virus. So self-collection is quite simple. There are numerous devices that are used around the world in the United States. When we got FDA approval, there's two devices, the Evelyn brush and the Copan swab, Copan flock swab, but basically both of them are used in a very similar way just by inserting into the vagina and collecting vaginal cells. So these do not have to be cervical cells that are collected or even cervical vaginal samples. There is high evidence that the vaginal cells that are collected by a woman or a person doing the test by themselves are sufficient and adequate for these tests. So just really quickly, I'll just review the evidence around self-collection because we're hearing a lot about it. Like I said, in the United States, there's quite a bit of buzz because it was finally approved by the FDA. Elsewhere in the world, this has been part of the screening strategy for a long time and we've heard World Health Organization really pushing for HPV testing and self-collection for numerous years. And so the United States is really excited because we finally have the ability to participate in that strategy. But just as a review, the sensitivity and specificity are similar when we use samples that are collected by a person themselves compared to when samples are collected by a provider. So we don't see any hits to either the sensitivity or the specificity. And the pool sensitivity for both provider-collected and self-collected HPV testing is 96% and specificity 79%. We know from a lot of research that this is highly acceptable to persons all over the globe. People find it easy to use and are very happy to collect their own sample versus have a pelvic exam requiring a provider. The most exciting thing for me is that regardless of how it's implemented, we see that self-sampling with HPV testing increases screening participation by about twofold, regardless of how it's implemented or in which population it's implemented. And so Stephanie Costa and Mark Arvin did this really nice review in 2022 looking at screening participation when self-collection was offered. And you can see that there's different ways of offering this. It can be done door-to-door by a community health worker. It can be offered at a clinic or it can be sent in the mail as being done in some of the European countries. And we see about a 2% increase fold and in places where it's being door-to-door such as many places in Africa and South America, we actually see that the participation rate it's up above the 90% when self-collection is offered. And so we have seen that this is increasingly used in national cervical cancer screening programs throughout the world. This map is a little bit outdated because this is 2022. So there are an ever mounting number of countries that are using this, but the green ones show the ones that have HPV-based screening or the capacity to do HPV-based screening. And then the orange ones have already implemented self-collection for all people who need screening. And the yellow countries have implemented self-collection for people who are underscreened. So don't participate in usual care and therefore could benefit from this alternative strategy. In the US, like I said, it's a really exciting time. Self-collection was approved by the US Food and Drug Administration in May. And there's been a lot of buzz about what's gonna happen with that. And so in the United States, this is done for healthcare settings. And so it has to be done under the auspices of a healthcare provider broadly. And this will include some nontraditional settings such as mobile clinics. So really will provide more access to screening. I mean, and they're saying that it's an option to a pelvic exam when it's not possible to have a pelvic exam. So it's an option if we can't have a pelvic exam. It was done in the United States with two tests. And these are the ones that are approved in the United States for self-collection. But globally, there are numerous other tests that can be done with self-collection. What's important here is that the test is approved for primary HPV testing and is a test because there's a lot of HPV tests out in the market. So there's definitely a lot of variability in how good HPV tests are. So whenever using this in a program, it's really important in your countries to make sure that the HPV test that is being used is one that has been approved and vetted and has gone through all of the clinical testing and on the list from the WHO in terms of the approved tests. But really what is exciting for us and what has already been an option for many countries is that we can use this to take advantage of opportunities when a person is coming to see a healthcare provider for numerous reasons. Maybe it's childbirth. Maybe it's coming in for their diabetes or their hypertension. Maybe it's coming in for some other chronic disease and having the opportunity to have screening be done outside of a provider who has the capacity to do either VIA or cytology, which is often a high level of capacity to be able to do that high degree of training. Instead, this will really allow for screening to be done by other people on the healthcare team, including community health workers, nurse midwives and whatnot. So the biggest challenges right now around self-collection, and I know we see this in Africa, we see this everywhere, and that actually goes for the United States as well, is that there really is little capacity in the labs for primary HPV testing. We definitely see this in Africa. In the map you saw that only a couple of countries have HPV testing as their primary screening strategy. And in the United States, it's the same. Only 2% of screening tests are currently done with primary HPV. So there's gonna be a lot of work that we're gonna need to increase our ability to get HPV testing available in laboratories so that we can use self-collection as well as many other challenges. So one really exciting thing that I've had the pleasure of working on with Mila is really this critical need to find point of care tests that we can use at decentralized laboratories so that we don't have to wait and batch samples and send them off to a central lab. And of course, even if we did have a central lab, the testing is very expensive. And so there are some commercially available point of care tests, but they are very expensive still. And so the work that Mila's doing along with our colleagues at Rice University is really working towards a rapid and low cost point of care platform that can be used for HPV testing that will require minimal training. And oh, there's Kathleen, and this is Kathleen's work too. And so this is some of the, I think the test that will really revolutionize our ability to use primary HPV testing as the precision test that the WHO is asking all of us to use in our countries. And so once we have these low cost point of care tests combined with self-collection, we really can have the opportunity to decentralize screening and get it into the hands of women and other people with a cervix who need the screening and broadly increase our access. So I will end right here because I know we're right at the hour, but my email address is here if you have any questions or any follow-up comments.
Video Summary
The speaker, a behavioral epidemiologist and implementation scientist, discusses advancements in cervical cancer screening, focusing on HPV testing. Highlighting the shift from traditional cytology methods to high-precision HPV testing, they emphasize the benefits of self-collection for HPV testing. This method has shown increased sensitivity, cost-effectiveness, and accessibility, particularly important for under-screened populations. The speaker notes the recent FDA approval in the U.S. and its potential to enhance screening participation. They also discuss ongoing efforts to develop low-cost, point-of-care HPV tests to further improve screening accessibility globally.
Asset Subtitle
Jane Montealegre
September 2024
Keywords
HPV testing
cervical cancer screening
self-collection
FDA approval
point-of-care tests
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