 Hey everyone, I'm Raif Darasi, and in this video I'm excited to sit down with our very special guest Tom Villa to discuss his work in HIV clinical trials. But first, I'll start by introducing our esteemed guest, Thomas J. Villa, otherwise known as Tom, works to help end the HIV epidemic by leveraging three decades of experience as a healthcare executive in biotechnology, graduate medical education, and community health. Tom serves as community advisor to various teams researching effective strategies to prevent, treat, and or cure HIV, including both the HOPE and RID HIV Martin Delaney collaboratories for HIV cure research. Those of you who have been following my content are very well aware of the Martin Delaney collaboratories, and I'm also in the HOPECAB. He has special interest in use of behavioral and social sciences research to enhance the impact of biomedical interventions through use of a participant-centered, full-person approach. Tom is a serial research participant himself. He has been a volunteer participant in more than two dozen HIV clinical studies, including several ongoing observational studies, early phase and phase one interventional trials, and those involving analytic treatment interruption. A practicing writer, Tom sees the arts as an untapped means to engage and inform the wider community, not typically involved in clinical research. Tom, thank you so much for sitting down with me and having this conversation. Thank you so much for inviting me here today, Rife. All right, well, I will start by asking you a very broad general question I ask a lot of our guests, which is, what is your current assessment of the state of the global HIV AIDS epidemic? Wow, that's a big one. So I think that overall, looking at the HIV epidemic globally, that we are obviously in much better shape than we were in 40 years ago and even 30 years ago in the early days of the pandemic. You know, we have effective anti-retroviral medications for people who have access to the medications, which again, we're getting better at providing. We're not there yet. We don't have access for everybody, but we're doing better than we were. For people who have access to medications, living with HIV is manageable. It's not a walk in the park, but it's manageable. But I think that that has added or brought new challenges for us. So people with HIV who are on medication live longer, healthier lives, but we also deal with complications or comorbidities, other health conditions that typically come with aging. We tend to suffer or experience more of them and at earlier ages than people without HIV. So while the HIV is manageable, other health conditions add other challenges. And I don't think that the health system here in the US has managed to grapple with that yet. We don't really have effective programs to help people manage that. We have a few pilot programs. It's an academic medical centers, but we don't have widespread access to effective programs. And from what I understand, similar is true in other parts of the world. So we still have a work cut out for us. Yeah, certainly. And I'm glad you've mentioned comorbidities. That's something that I'm talking about more and more on this channel because for a long time, for me, my messaging was very black and white. It was once you're on HIV medication and you're undetectable, you live a long and healthy life. There's nothing else really to worry about. And the more I learned, the more I realized that it's way more nuanced than that. Way more nuanced. It's important that we're having that discussion. And I'm glad that you brought that up. I mean, your perspective that you just mentioned is not a surprise. I think one of the challenges is that our approach to HIV here in this country has been a public health approach. So a public health is focused on providing population level intervention strategies to try to reduce or eliminate a public health risk from a disease that can be an infection or disease like COVID or HIV that can be passed within the community. And that's all fine from a public health perspective. That's important and necessary. But then there's the whole other perspective for people living with HIV, the response really needs to be a healthcare services response. And our healthcare system hasn't really caught up to everything yet. So it's two separate responses. And all of our federal response has been on the public health side. There has not been a coordinated response on the healthcare side. So again, some academic medical centers have done a good job of piloting programs to help people aging with HIV. So it's not that there hasn't been any attention. There has been. But at the systems level, there hasn't been enough. So for instance, Medicare is not doing anything in terms of managing aging with HIV. And we don't see programs at the federal level necessarily focusing on that either we have funding for some pilot projects, but we're 40 years into the pandemic. So that's such a great distinction that you're making the two approaches to addressing the HIV epidemic here in the US. I've never heard it put like that, but it makes it very a lot clearer for me kind of in my head what direction we've been focusing on and what direction we need to also tackle. Right. We need we need both. It's two separate systems. The public health system is not the healthcare system. So some of the physicians, some doctors, particularly those who work at academic medical centers, may be involved with both. But your typical physician that you see in the community is not doesn't work with public health. They're not involved with public health. So it's it's really it's two separate systems and they work differently. Their funding is very different. There are approaches are very different public health focuses on groups of people, the population and healthcare focuses on you or me as an individual patient. So it's too separate with your understanding of the two systems. Do you think that they would benefit working together? Well, it's not that they don't work together, but as with any large system, you know, they're each system has its own rules. They have their own funding streams or payment mechanisms. So it's just it's complicated to get them to really mesh, if you will, they're focused on different different aspects. They're focused on the pandemic from different perspectives. And again, a lot of the federal response has been on the public health approach. I think there's opportunity for more federal response on the healthcare approach. We need the centers for Medicare and Medicaid services to step up and to become more active and to take a larger role in helping to address this within the Medicare system. And but with that said, the Medicare, Medicare, which covers health insurance provides health insurance to older Americans age 65 and older. There are lots of things that people 65 and lots of other conditions that affect more people than HIV. So it's a challenge. Okay, well, before we jump into the topic of clinical trials and all all of your experience there, I want to ask you a little bit about your about you personally. When were you initially diagnosed with HIV? So I've been living with HIV for 25 years. And as you can imagine during that time, have seen, you know, significant changes in how HIV is managed, what we understand about it, how it's managed, the treatment for it, etc. And as I mentioned, things have come a long way. So they're much better today. We still have work to do, but much better today than they were 25 years ago and certainly better than they were back at the beginning of the pandemic in the 1980s, which I also remember. So in what are some of the ways that things have changed for you since then, since you were initially diagnosed? Well, the treatments are much better. So, you know, now treatment comes down to taking typically for many people, one pill once a day. That was not the case initially. So initially, you had to take combinations of medications that often multiple times a day and different medications had different requirements. Some could be taken with food, some had to be taken with food, others could not. And they had all kinds of challenging side effects. They were much more toxic than today. So the medications have improved greatly. They're more effective and they're easier to take. And then there are longer lasting options, long acting options today too, where you don't have to take a pill a day, but you can perhaps have an injection that lasts for a month or two. And at some point in the future, probably much longer. So that's all gotten better. And I think that from the standpoint of the public understanding of HIV, there's much more in depth information about what it is and how to prevent it and how to manage it and live with it. And how to avoid passing it to other people. So all of that is much better than before. We need to continue to make sure that that information is getting to all the people who would benefit from hearing it. And that's a challenge because there's lots happening in the world and lots of information to share. So that's always a challenge. Well, you're doing a lot of work to help contribute to dissemination of all that information, including sitting with me today. So I appreciate it. Well, thank you. How did you initially get involved with clinical trials? I worked back starting back in the late 80s. I worked for a biotechnology startup company that developed and introduced into clinical practice new technologies to diagnose and monitor cancer. So I was pretty familiar with clinical trials, sort of what they are and how they work and all those kinds and understanding the results because that was part of my work in the field of cancer. But going back to the 80s and 90s all the way up through the early 2000s. But I had never participated in a clinical trial myself. So my initial involvement really came from reading about one of the outbreaks because there have been more than one. There have been a number. Outbreaks of the Ebola virus in West Africa. And in reading about the sort of the desperate attempts to sort of control this contain this really dangerous virus that was killing so many people and work that was initial work that was being done by scientists to try to develop a vaccine. I realized that because HIV is very prevalent in West Africa where these Ebola outbreaks were that any vaccine would have to be tested and shown to be safe and effective in people living with HIV before it could be offered to people in West Africa. And so I said to myself, hmm, there's a chance to put my virus to work. I can volunteer for one of those. And at least that way I would be doing something useful with my virus and make making my virus work, basically. And so I found the name of the investigator in the in the newspaper article is reading and I wrote to her and said, hey, when you get to the point where you have clinical trials, keep me in mind how do I join. I didn't hear back from her, but I sort of kept that in mind and found another opportunity to participate. So I did participate in one of those and since then I've participated in a bunch other HIV related clinical trials and is an investigator. Is that just the person that's actually doing the studying and the research because I know in being in hope in the hope cab. We have our principal investigators and no one actually sat me down and said, this is what a principal investigator is. And I have no idea PI. So there's a lot of terms like that that I think community can benefit from understanding. That's a great point. So yeah, so investigator and researcher really mean the same thing. Very but but the principal investigator, the PI or PI is because sometimes the study has more than one. Those are the ones who are the like the lead researchers for that particular study or that particular research team. And then there will be other researchers who are part of the team like staff members on part of the team. And they may just be called investigators or researchers or research staff, but they mean essentially the same thing. Did you have any concerns for your safety or your health when you did the initial clinical trial or was your past experience with cancer treatment enough to kind of alleviate that? No, well, I think anytime you participate in a clinical trial, you need to sort of understand what it is that you may be getting into and talk about that with the study team, the research study team. And hopefully with your own physician, your own health care team and your family or friends or other people that you trust and see whether the trial might be a good fit for you and whether you feel comfortable. And for me, not only whether I feel comfortable, but do I think that I have something special or unique or meaningful to contribute to the trial. So in the case of the Ebola study, as I said, the Ebola vaccine study, I knew that because the vaccine was needed in West Africa and HIV was prevalent there, it would have to be shown safe and effective and people with HIV. So for me, that was enough to say, look, I can do something unique. I can, you know, because I'm living with HIV, I can add something unique to this study. That was my motivation to volunteer. But yes, you need to make sure you understand what you're getting into and that you think it's safe for you based on your health and everything else at that time. And were you in that trial getting exposed to the Ebola virus? No, no, no. This was a vaccine. So it was a vaccination to prevent Ebola. I participated in the trial where a portion of the volunteers like myself received the vaccine to see if it was safe, if they had any side effects from it. Did it generate an immune response that looked likely to protect them in the future from exposure to Ebola? And then other people got a placebo, which was typically saline water or something like that, which has no effect. But that's how they run a trial. They give some of the participants the actual vaccine and some a placebo and then compare the two groups to see if there was a difference. So no, I was not exposed to the virus. This was just a phase one trial. So it was just seeing whether this vaccine was safe and effective. I mean, that and that touches on something my ignorance in that knowing that you can look for certain markers without having to expose someone to whatever they're hopefully being vaccinated against. You can look for certain markers to see that they would have an immune response without having to expose the person to that thing because obviously there's moral concerns there. Yes, good point that you bring that up. So during the recent COVID-19 pandemic, vaccines were tested and the way that they were assessed to see whether they would be likely to be effective was that they did exactly what you just said. So volunteers who are in these clinical trials got the vaccine and then they had blood drawn later and scientists looked at immune markers in their blood to see whether their body had generated the immune response that would protect them likely to protect them against a future exposure to COVID-19. There are some trials for things that are less dangerous. There are some trials that do require or do involve exposure to the actual virus or pathogen, whatever it happens to be. But those are sort of unique and they would not use that kind of a trial for something as dangerous as let's say Ebola. Okay, good clarification. So many people are interested in clinical trials, ask questions about it, how can they get involved as it relates to HIV cure and HIV medications. But there is a bit of a veil of secrecy or at least a lack of information when it comes to clinical trials and what that entails, what's it about, how does it work. Can you walk us through what a typical clinical trial might look like from the vetting process to the clinical trial itself to afterwards follow-up, anything like that? Wow, okay. I know I asked you a lot. No, no, no, that's okay. Let me mention first of all for people who are interested to learn more about this, the National Institutes of Health, the NIH Clinical Center has on its website like a tutorial or an introduction for people who are interested to learn about clinical trials and the steps that are involved. So that's something that we can provide, a link to that if that's helpful. I think they do a pretty good job of stepping people through what the various steps are. In terms of what would this look like for a potential participant, I guess the first step would be how did you find out about the clinical trial. So many people find out about the clinical trial because their healthcare provider, their physician, talks to them about it and says, hey, there's a clinical trial about XYZ. I think you might be a good candidate for this trial because you're living with HIV or you have XYZ situation, condition, and would you be interested in learning more? So a lot of people would find out about it through their individual physician. Of course, you can look for clinical trials on your own. So you could go to the website clinicaltrial.gov and that's like a government supported website that lists all of the different clinical trials. And you can look them up based on health condition and location and everything else and learn about what's happening in your area, but that's a little daunting. I mean, there's a lot of information and some of it's pretty technical there. So you can do it, but that's probably not how most people find out about them. And then of course, you know, there are posters or flyers in health clinics or you may see them in the newspaper or online announcing a particular clinical trial in your area that's looking for volunteers. So typically, the first part would be that you decide you're interested for however you learn about it and you contact the study team. And they would typically have some sort of a screening process where they would ask you either over the phone or online or in person. They would ask you a series of typically a few questions based on your age and whether or not you have the health condition they're studying and some other sometimes some health related questions to see if you might be a good fit for the trial. And if you might be, then they would typically invite you to come in and to meet with them in person. And then you would have a more in-depth discussion about what the trial involves and what qualifications, if you will, would qualify you for the trial or which ones might exclude you from participating, etc. Just before you continue on, do you typically do you have to reside in the geographic location where the clinical trial is being held or are there instances where people are flown to a location and congregated together? That's a great question. It really depends on the individual trial. So many trials are looking for people who live within, let's say, commuting distance, if you will, of the particular site, the health clinic or the research site where the trial is taking place. Because they many might involve frequent visits over a period of time, you might have to come in once a week for a couple of months or somewhere longer. You might come in once every month or once every two months for a year or two years. So that would be a lot of back and forth if you didn't live in the area. But there are some trials that would provide transportation, whether it's local or long distance, it really just depends on the trial. And then the other thing is there are some not really clinical trials per se, but what they call clinical studies. So these would be observational studies where they're just trying to understand more about a better particular condition or individuals who are living with it. So they're not testing a vaccine or a treatment. They're just studying people, the condition and what it's like, the experience of living with it. There are some that you can participate in virtually. So that's an option for people as well. Great. And then so say you do the questionnaire, you meet with them in person possibly. Everything looks good. You're approved for the clinical trial. What happens next? The team would have somebody review what they call in the informed consent form. So that's where you would sit down and go through in great detail, talk through what the trial involves, the potential risks and benefits of the trial to you as a participant. Whether there's any support provided like transportation assistance, whether there's any compensation with the trial, some do some don't and sort of what you can expect in terms of your schedule and the timeline for completing your participation, etc. And then if you feel comfortable and you agree to participate, you would sign the informed consent form. And then you would be in the trial and you would follow the schedule that they've discussed with you for however many clinic visits might be involved. And typically involve a physical exam of some kind, depending on the trial, probably some laboratory work, some blood testing. It may involve surveys or questionnaires that you would fill out either in writing or they would ask you sort of in conversation during your visit. But all of that would be spelled out and explained as you discuss the informed consent and sort of what the whole trial participation would look like. Okay, and then once that the clinical trial is done, do they send you on your merry way? Do they go over their findings with you? Is there like a dialogue that happens at the end? Yes, they would send you on your way. So when you're finished, you would know as you're going through the trial, you know, you'll be able to watch your progress based on the schedule that they've mapped out for you as an individual participant. You'll know where you are on your map in terms of completing your participation in the trial. When you have finished, there would typically be some, there may be some sort of follow up. So it really depends on the kind of the trial. Maybe your trial was relatively simple and you finished and that may be it. There may be others where there's follow up schedule that certain times in the future, check back in with you. Again, it really depends on the trial itself. The same is true when it comes to sharing the results, the findings from the trial with participants. So that's something that researchers generally try to do, but results typically, they don't know the results of the trial when your participation is finished. So, you know, the trial may have, if it's an early phase trial like some of the ones that I was in, there may only be a dozen participants, but others may involve hundreds or even thousands of people. So it may take months or years even for them to finish recruiting and doing everything that needs to be done with the trial with all the other participants. So they wouldn't have results for some trials for many years after your participation is finished. And then it may take another months or years for them to analyze the findings and to write and publish their findings of the research and then to begin sharing that with the public. So it's really a lengthy process. And that's something that you can bring up with the research team when you're talking about participation. When will you have any results? How are you going to share those with me? I'm interested or I don't really care, whatever the case may be, in hearing the results, let them know. And have you noticed a difference in the way that clinical trials are executed or how they've evolved over time since when you first started to present day? I mean, each of them is really different and they're designed and conducted by individual teams of researchers. So it's a little bit difficult to compare one to the next because they're each kind of different. I mentioned earlier one that I participated in that was a vaccine trial. So that was sort of set up and run in a particular way as a vaccine trial. I've participated in others like the one looking at HIV cure. So whether a combination of monocle antibodies might help to help my immune system control HIV without the need to take medication every day. So that was very different from the vaccine trial. And then there are others that I'm in, like I'm in one that's a 10 year study for HIV neurocognitive disorder. So this is really just, they're not testing anything, all they're doing is studying me and the other participants. So we come in once a year for a three day visit once a year and go through a whole bunch of tests through an MRI neuro psychology testing where you do memory exercises and word games and numbers to see how your brain is and your memory are working. And they basically just compare that year after year after year after year to see if there are any differences over time from aging with HIV. So they're not testing a treatment of any kind. They're really just seeing does HIV living with HIV for long periods of time. How does that does it affect the brain and if it does have so they're very different. That's fascinating to hear too. Yeah, and I find the trials interesting. So you asked before how to get involved. I mean, for me, if I'm going to volunteer my time to go participate in the trial, I want it to be something, as I mentioned, that I feel that I have something special to contribute to the trial. And something where I think the trial is interesting to me personally, I pick every brain every time I go to the for my visits. So I ask lots of questions. I try to learn as much as I can while I'm there. It is it's interesting in in talking about these clinical trials. One thing that I've heard about recently and learned more about is something called an ATI or an analytic treatment interruption. Can you explain what an ATI is and why it's sometimes necessary. Sure. So let's maybe before we talk about a treatment interruption, we can just talk about treatment for HIV. So I'm sure most of your listeners are familiar with the fact that the recommendation for anybody living with HIV is that we start on treatment immediately after diagnosis and that we stay adherent to treatment. So we take it as directed typically once a day and we do that consistently in order to achieve an undetectable viral load and that having an undetectable viral load is what enables us to live a long and healthy life. And it also means that we can't transmit HIV or pass it to other people through sex as long as we're on treatment and viral load is undetectable. So that's sort of the guideline, if you will, and people understand that as undetectable equals untransmittable u equals u with clinical trials that are working towards research being done to develop ways to potentially cure HIV in the future. Sometimes the only way that the researchers can tell whether the treatment or whatever it is that they're testing in the trial. Sometimes the only way we can tell whether that made a difference or not is to ask the participants to voluntarily stop their HIV treatment for a period of time and then to see whether their HIV will rebound to become deductible again and how long does that take. And is that longer or shorter than what we would normally expect. Sometimes, and that's called an analytic treatment interruption where you stop your HIV treatment in a clinical trial, not not at home on your own, but in a clinical trial we are closely monitored. You typically come in every two weeks, sometimes perhaps once a week. You have clinic visits, physical exams, laboratory tests done to make sure that everything is still safe. And that you're not having any harmful side effects, and they would monitor to see what effect, if any, the treatment they're testing had on your ability to manage or to control the HIV without your regular HIV medications. It seems like there would be a number of implications there. The possibility of developing a drug resistance while the viral load is rebounding. Maybe there are long term effects of viral load rebound on the body that we don't really know enough about is how do we tackle considerations like that. Yeah, that's really important questions. So yes, that's why I mentioned, you know, treatment interruptions are not something that we should do at home. Don't try this at home. They've been shown treatment interruptions were tested years ago, just in general, back in the early days of HIV treatments when the treatments were more toxic. One of the challenges was that when you were taking HIV medications every day for a long period of time, the side effects could get really challenging, really difficult, really hard for your body to deal with. So one of the approaches that was tested in clinical trials like we're discussing was what was called intermittent treatment or treatment interruptions where you would cycle on and off your ART. So you might take your medication for a certain period of time, and then you would take a break, and then you would go back on treatment. And so those that those approaches were actually tested in clinical trials to see did they work to help people control the HIV. Did they did it help reduce the side effects that people were dealing with from the medications? Did it lead to problems like drug resistance that you talked about, etc. And in general, it was found was that that approach is harmful that it did not control HIV effectively. It might have reduced side effects from the medication, but it didn't control HIV effectively and it did lead to problems like drug resistance, etc. So those approaches were sort of put aside as not good. So you're right. In general, we do not want to interrupt treatment as a general rule. However, as we mentioned a minute ago, in some cases, in a clinical study, we might need to in order to find out whether this new experimental treatment makes any difference or not. So in these limited cases, we might have to take that risk. And it is a risk. You do if you're a participant, you're taking some risk that there might be side effects or other unwanted things that come come from this. You mentioned drug resistance. There's a possibility that that because of the treatment interruption that when you restart your medication after the treatment interruption, that you that the old medication that you were taking may no longer work because your body developed resistance or your body developed resistance to it. That problem has been dealt with pretty well, because researchers have figured out at a structure of the treatment interruption so you taper off certain medications and so that's been that problem is really not a major issue any longer. It's still there, but but it's not nearly as common as it used to be. There might be some short term risks from a treatment interruption and analytic treatment interruption during a clinical trial. You might have your HIV viral load becomes detectable again. So it's possible you could pass HIV to your sex partners. So that's a potential risk and you have to take steps to prevent that there's a possibility that if you're living with other viruses. Let's say many of us are living with, let's say if you had chickenpox when you were a child, you have still have that virus in your body, it could theoretically become reactivated because of the stress from having the HIV come back without medication could reactivate other viruses like that and you may have some side effects from that. And there are other, you know, many of the human papillomavirus, cytomegalovirus, herpes, simplex virus, these are all viruses that are very common among many people. And they could become reactivated during your treatment interruption, because your body is stressed out trying to manage the HIV in addition to everything else. Again, I think that researchers have learned a whole lot over the past two decades, and that's why these treatment interruptions are set up in a way where you're very carefully monitored. You're coming in every week or every two weeks for clinic visits, you're having safety lab tests done. So I think the short term risks are pretty well understood and very well managed the longer term risks are not as well understood. So as I'm sure you can understand, in order to sort of assess the long term risks, you have to take a long time, you have to do studies that are 10 or 20 years long in order to see, well, what's the effect of these treatment interruptions in 10 or 20 years. So there's one study that was published two or three years ago from Barcelona, Spain, that showed there are long term risks from treatment interruption increases in things like heart conditions and stroke and cancer. So we certainly need to pay attention to those. That was one study in one place, and the people who participated in it had gone through, they had been on all different kinds of medications, and they had gone through different kinds of treatment interruptions. So we just, we need to do more studies to understand this better. And I think that that's something that would be really important for for us as a research community and HIV community to push for. Yeah, so thank you for highlighting all the considerations. I think that it's, it can be very exciting, the opportunity to be part of a clinical trial that maybe is testing a vaccine or a potential cure, or a new medication. But, especially if you're living with HIV, something like an ATI is not something to be taken lightly. It's something that you should really be informed about, know your risks, and be able to make an informed decision. Yes. Yeah, no, that's a really good point. I think I've heard some people say that they would be interested to participate in a clinical trial focused on HIV cure, because they want to take a treatment holiday, they want to be able to have the treatment interruptions so they can take a break from taking their normal HIV medications every day. I think that is not a good way to think about this. Treatment holidays have been shown by research not to be good for us. So they can produce harm. So we don't want to take treatment holidays. I think that the reason to participate in an ATI, an analytic treatment interruption, is only in the context of a clinical trial where you have your research team, you have your regular HIV doctor, all of you on the same page. You're talking to each other, you know that you're participating in this trial, and you're all watching to make sure that it's safe. And considering the potential long term effects of an ATI or just whatever treatment you're getting as part of the clinical trial might have on your body, is there any responsibility on the investigators part over the long term once the clinical trial ends? Certainly if the investigators find through their analysis of the research of the data they collect during the trial, if they find that there are risks, then they would reach back out to participants. So they would in fact reach back out to participants and say, hey, we just want to let you know we found XYZ risk. We're letting you know that this is what we found. We'd be happy to share this information with your healthcare provider so that you can look out for it. So they will do that. I think that there's an opportunity for the research community to set up a some maybe let's say as some sort of a registry where people who have participated in an analytical treatment interruption like myself could volunteer to participate in this sign up or register in this registry. So that would help the research community to monitor how we do over time. I think that would be a really important sort of like next step or study to look at the long term effects of treatment interruption, if any. It may turn out that there are no major effects and that would be wonderful. But I think we won't know until we look so we need to figure that out. And if we're going to be asking more people as so we're making steady progress in this research towards a cure. As we do that, if we're going to be asking more people to participate in these kinds of trials, then I think we we do owe it to them as you mentioned to have something in place so that we're looking at what the long term effects might be. Yeah, it's to me it's almost intuitive. I maybe say obvious that there should be some kind of registry to be able to have a log of people everyone that's involved for long term possible effects but I can I can understand and see that from the investigators point of view that might not be their primary concern or their focus and so that might be like a blind spot for them. They're worried about this clinical trial and then move on to next research. Right. And the thing is that that kind of a registry would have to be set up as a trial, like a whole separate trial. So it wouldn't, it wouldn't necessarily involve only the people in that one trial. I think the registry would ideally would invite people who have participated in any and all trials with an analytic treatment interruption to participate in the registry. So that would really have to be set up as its own study and have its own research team and its own funding and. And then you have to figure out how do we find and keep in touch with all of these people who, you know, over the course of five or 10 or 20 years, you know, have may move they they have all kinds of changes in their lives and we have to figure out ways to keep in touch with all of them so it's a you know it's a relatively heavy lift if you will, but I think that it makes sense to think that way. And I think another potential benefit of that would be just having a larger pool of data and having that kind of cross communication and connection with various studies. Yes. So I think if we want to sort of think big picture now or talk big picture. I think one of the shortcomings if you will, or one of the challenges for clinical research hiv cure related clinical research at this point is that a lot as we mentioned earlier that clinical trials are sort of designed by an individual team of researchers. And then they're conducted at specific sites, you know, locations or clinics. And unless you happen to have some way some contact with the team or the researcher at one of those clinics, you may not even learn about the particular trial so you have no chance to even participate. And your clinic may participate in some trials, but not in others. You know, there are a whole lots of trials for all kinds of things taking place all over the world all the time. Your particular healthcare clinic or doctor or hospital obviously doesn't participate in everyone. So what I think would be interesting or helpful would be to have a central service if you will, like clinical trials. But which included not only clinical trials of interventions like new treatments, but other kinds of clinical research that may just involve surveys or other things that you could take virtually that where you would be those might also be listed in that same directory, where we could offer people other ways to participate in between these interventional trials these treatment trials or other things that take place. Well, I've taken note of these suggestions for the possibility that I have an interview with investigators or any other potential decision makers funders who can kind of get us closer to that goal because it sounds like it would have a huge impact. Well, you've also mentioned partner protections. Yes, when it comes to clinical trials and ati specifically. Why should we be concerned about the participants partner or well if any. Yeah, thank you. What if any current safety mechanisms are in place. So I think traditionally the trials that involve an analytical treatment interruption where you go off your medication for some period of time. And therefore, if you have some, you're no longer undetectable during that time, you might have a chance of passing HIV to sex partners trials would require that participants use condoms. In order to prevent transmitting HIV unintentionally to their sex partners. So that's been the traditional approach over the past decade, as we mentioned earlier that, you know, the whole concept of you equals you has become really I think the what most people count on for prevention of transmission to sex partners. So if I'm living with HIV, if I'm taking my medication, and I have an undetectable HIV viral load. I know that I can't pass HIV to my partners. And my partner also knows that if I'm taking my medication that I can't. And I'm undetectable that I can't pass HIV to them. I think the norm in many places in many communities has become that people are counting on you equals you, and they're counting on the fact that prep is available to people who are interested in taking it to prevent themselves from contracting HIV through sex. So, I think that there's much less. It's less common perhaps that it used to be back in the early days of the HIV pandemic, for people to disclose their HIV status. So I think we need we need to help people who are participating in these trials, who were asking to stop their treatment temporarily, we have to help make sure that they're not passing HIV unintentionally to other people. And you say we have to do you find that there is mechanisms in place to kind of educate and support participants in that way or is that something that needs to be addressed. Again, I think the traditional approach has been for clinical trials to include as part of the informed consent process that the participant agrees that they will use condoms. We also know from lots of other research that condom use is very low. Many people don't like to use condoms. So I think that we need to do more than simply making condoms available. We also know that these days that prep helps prevent HIV transmission. So we're acquisition. So one of the additional ways is to make prep available to the partners of participants if they're interested in using prep while the while the participant is volunteering in the trial. So that's something that the research study site could locate in their community, other physicians or clinics that provide prep services and then help the participant and their partner linking them to those services so that they can get prep. So that's another step. There's safer sex education that that could be part of the solution, making sure that the participant in the trial and their partners understand ways that that we can have sex more safely with lower risk of transmission while the person while the participant is off their HIV medications during the trial. I think that there there's been research a group of us have published some recommendations in terms of making a formal partner protections package where all of these different techniques would be available or that research teams would learn about these techniques and they would have all of these different opportunities and support systems in place while they're conducting the trial so that participants have different options. Fantastic. So you you're developing or have developed this partner protection package. How are you getting this out to researchers? Is there a site or a place that they can go? This is work in progress. So the and there are a bunch of different groups who are working on this. So Dr. Michael Paluso at the University of California, San Francisco and Korean Dube at the University of California, San Diego have been promoting these approaches both in their clinical sites where they're conducting research, but also on a larger level through publishing their recommendations in professional journals and also to the age clinical trials group, which is the network that runs many of these clinical trials. Fascinating. Wow, we are already like approaching the hour here. I feel like we are just getting into this thing. It's there's so much to talk about. But before I wrap, I do want to talk about your interest in using art as a means to engage and inform the wider community. So as I'm sure all of your listeners can tell from listening to the conversation here, clinical research is pretty complicated, pretty complex. As you mentioned at the beginning of the discussion, you know, there are a lot of like acronyms and technical terms and other things that are difficult to understand if this is not your work and you're not doing this every day. And there are a lot of people who just may not know about or even be interested in all the hard science, technical aspects of clinical research. But I think that the arts can really help us reach more people. So for instance, if I mentioned or you mentioned in the introduction that I'm a writer. So for me, by writing about my experience living with HIV or participating in some of these clinical trials. I hope that I can help sort of humanize and make more real some of these experiences in ways that other people can read and say, Oh, I get that I understand or hey, I've been through that too. There are other people who may use different art forms. So they might paint or they might create podcasts or or music or or some other approach that helps get people's attention and then gives an opportunity to talk about some of the things that we've talked about today. Where maybe it's not hard science and less maybe a little less technical but but where we can share information. So I think there's lots of opportunity to do that. I agree 100% and that's in part why I'm also doing what I do on social media as my own light kind of art in a way. Fantastic. How can folks follow your writing and or anything else that is going on with your life or that you're sharing. Well, I've published some things in positively aware. I have some that I will be submitting to other magazines like the body calm and a new magazine. I do not at this point have my own website or YouTube channel. It's something I'll consider in the future but I'm I just have to see where that goes. Is there anything before we wrap up that you would like to share talk about cover before we end this. I think just about in clinical trials and clinical research in general that my experience has been very good participation does take dedication and because it takes time and effort to participate. You've got clinic visits and lab work and typically various kinds of medical procedures that are involved. So it's, you know, it involves commitment of work, but I feel that that it has been a way for me to contribute. I'm grateful for people who contributed in the past who participated and through that helped scientists to develop the medications that keep us healthy today. So my participation is a way to sort of pay that forward to future generations and I would encourage people who might be interested to learn more and to really give it a serious thought as I said has been a really good experience for me overall. I've met lots of wonderful people. I have found many opportunities to make my virus work as hard as I do so. Well, thank you so much for taking the time and energy to give us a really good clinical trials one on one. I have a feeling that there's going to be a lot of follow up questions and comments to this interview so I would love to bring you on at some point to kind of dive into this a little deeper possibly answer some questions that that viewers might have if you're open to it. Absolutely. And I will definitely be posting the the two resources you mentioned one the NIH clinical sector and then also the clinical trial.gov link I'll have those both below. People can check that out and I'll include the ACTG as well. Why not. All right, everyone at home, please comment below your thoughts, comments and questions. I'm happy to follow up after the fact. Tom is ready and willing as well. And Tom, a huge thank you to you again for being so gracious everyone at home. Thank you so much for watching. Be sure to like this video. Subscribe if you haven't already hit that bell so you get a notification every time a new video comes out and please share this with anyone who might find value in this content. That is the best way you can help support me and my channel. All right, until next time. Cheers.