Men’s Health Foundation Podcast Episode 10 Transcript

David: Today in the United States, about 25% of the population living with HIV are women. About 20% of new cases in the U.S. are women. And at Men’s Health Foundation, you know, we've historically focused on HIV treatment and prevention. That's how we were founded. HIV treatment prevention and research and, you know, recognizing Women's History Month and those statistics.

We absolutely want to make sure that we spend enough time talking about women in HIV. what the options are today and what the options might look like in the future. And, we're lucky today to have, three great guests with us to speak about this. This is a new record for us. We've got, Erica Kill and Ashley Toomey from Mills Clinical Research. Thank you so much for joining us.

Erica: Thank you so much for having us.

Ashley: Thanks.

David: And we also have our staff physician, Dr. Manuel Pardo. Thank you so much for being here.

Dr. Pardo: Absolutely. My pleasure.

David: So getting things started, I wanted to make sure to first kind of make sure that we discuss Mills Clinical Research, what that does and the role that Mills Clinical Research has as far as being a resource, for women who have concerns about treatment, prevention of HIV. So how would you maybe describe that to folks who aren't familiar?

Erica: So we have studies that emphasize STI treatment and prevention, specifically with HIV. Recently we had a study for PrEP that, they allowed us a certain amount of participants to screen, but those participants had to be female. And, and we weren't able to screen for male participants until a little bit later. And they really emphasize on female recruitments and are trying to bring more awareness into the general population with education on HIV and HIV prevention.

Ashley: I think, it's really important for women to be included in the research because it wasn't even mandatory for women to be included in research until like 1993. So it's now mandatory for a certain percent of each study to have female inclusion in women be included in the study and that's just creating like a representation of how that medication works for them since women have different attributes, like they have hormones.

And everything going on that are different than men. So being included in these medication studies, makes it so that we can accurately say how that medication is going to affect women in the future when it is approved or rejected, whichever one.

David: That's wonderful. So I think it's also really clear that, while being a partner with Men’s Health Foundation, that this kind of research is absolutely actively recruiting women participants in clinical trials.

Erica: Yeah. And we put an emphasis on recruiting different ethnicities and races in our clinical studies. So we try to reach a broad spectrum of not only families, but diverse populations.

David: Sure. And I mean, you know, talking about the statistics earlier also, of course along with that, just as it's true for gay men, HIV disproportionately impacting communities of color in the United States with new infections and with infection rates, nationwide. And I wanted to make sure to ask you, Dr. Pardo, with your experience with infectious diseases, your focus on HIV, what have you observed as far as, just those trends, as far as the level of awareness, of women's risk, with HIV and, you know, how that has been, something that you've observed or not, over the years?

Dr. Pardo: It's a very important question because unfortunately, we do see, with the, epidemics of HIV in the United States that there is not enough awareness. We're not doing a good job. women are at risk, and women are now leading the, infectivity rate in the United States. We may live in a bubble community like in California, where there's women who are more knowledgeable.

Perhaps either they are having more access to PrEP and/or they admit the risk and/or are aware of the risk and have access to PreP. But definitely when you see the demographics of what's going on in the United States it’s more so on the Southern states. So, the Bible Belt, excuse me and Florida have been the areas that are the hot topics of unfortunately, HIV transmission when we have such significant, great medication that can prevent HIV.

So that is very, very sad and sometimes even embarrassing to see that there is not enough coverage and or access to PrEP for, for not only these women, of course, but also like all, all communities that should not be left behind. So I think that what you described before of the inclusion of the studies, it's, it's of prime importance.

And we heard of that diversity, equity and inclusion, like DEI. It's really important now with what we have. But that is so, so, so important that we are including women because it's a community that we cannot leave behind. And then we should study more specifically in the United States.

David: Why do you feel like that there hasn't been an adequate focus on that so far in the conversation?

Dr. Pardo: When you say the conversation, you mean about including them in research?

David: Maybe just awareness of, the rates of HIV infection and in women and just how, you know, 25%, approximately of the population living with HIV in the U.S. are women. I feel like, you know, Marc and I were talking about it and I feel like a lot of conversation around HIV is focused on, gay men, whether that's in, you know, stories told about HIV or media coverage.

Do you feel like there's an adequate representation, or awareness of just the role, just sort of the, amount, the percentage of women that are impacted by this?

Dr. Pardo: Right. I don't think there is. This is why then there is that, that lack of access and/or more so the patient is themself either knowledge, but also stigma, remember how the stigma is also like so important. And even in the communities that I described before of like either being associated to a characteristically and stereotypically known to be a “gay disease”, part of like a “promiscuous” disease.

So they don't, they don't want to be associated with that. And that is a challenge that culturally, has been ingrained in the, society like the feelings and the perspective of that being– have embarrassment to reach a sexual clinic, have the embarrassment to be, stigmatized as a promiscuous woman, and not knowing the risk.

And there's sufficient data that shows that it's not only about frequency of sex. You only need to have one sexual encounter where you're going to be HIV positive and we want to prevent that. Again, I could not highlight enough of how good medications we have that are so effective and have so– that are so safe, that it should really be implemented for those persons who are at risk.

So identifying those women, make them understand that they are at risk. It is an important first step for them themselves to reach care because there's no other medication. The best medication that there is, is the patient– the one that the medication takes– the patient takes because you can prescribe and offer something. But if the patient is not going to take it, then well, that's not going to be a great medication, right? So, we need options and we need more options for each one of the lifestyles of women. And that's an important one to understand. And there's more research being done about it. And, and there's more done– more work to be done about like, what other options we have specifically for this, subgroup of community of patients at risk for HIV.

David: And speaking of, you know, specifically women at risk of HIV. And going back to the clinical trial you were talking about at Mills Clinical Research what's been your experience in the women that you've been talking to, prospective participants and participants in your trial, what have you observed? What surprised you about what you knew about, you know, their own perceptions of HIV and their own awareness of HIV?

Erica: When screening for this PrEP study. It's an injectable PrEP. A lot of the women, I want to say probably 90% of the women that I screen for the study, they had the, mindset of this is like, that only gay men can get this, and the education around HIV, it was very limited.

I think I had a discussion with one of my participants about how, sexual education in the United States is, is not the greatest, and how for females specifically, sex health is kind of emphasized with, reproduction and not a lot of STIs, and HIV, kind of shows when I am speaking to them ‘cause they’re like, “I didn't even know I could get HIV,” and explaining to them that anyone that has any sexual encounters is at risk for HIV and also explaining how there's more, there's other ways to contract HIV. IV use, so many other different ways, even like in a clinical setting, if you get a finger prick, you have, you're at risk for contracting HIV.

And I think with this new study, it's an injectable every four months. It also helps with the barriers of access so you don't have to take a medication every day. And we can come in every four months and get an injection and then move on with your daily activities and have, not have to think about it in the back of your head.

Ashley: I think the injectables are very, like a very important advancement that we're doing right now with research, not even for prevention, but for also treatment. So a lot of the stigma comes from women being scared to take the daily medication or people seeing them take that daily medication, partners of theirs, like they don't want people knowing that they're doing that.

So if we can implement injectables where they come into the clinic for they can say whatever they want to say, it is like an annual physical, and they get their injection and then they're okay to go, like that really decreases the amount of anxiety around taking that daily pill and having people see you take it. And that is one of those, triggers and that keeps them from getting treatment or taking PrEP.

And there's just been so many women that we've talked to that didn't even know about PrEP or didn't think that they needed it. Statistically, there's not a lot of women taking PrEP that could actually benefit from it. I think it was like 15%. So there's a lot of education, I think, behind prevention for women that needs to be done to be able to get women up to where they should be preventionwise.

David: Wow. Wow, it's, it's interesting to hear that. I mean, even in like LA in 2025. You know, Dr. Pardo, I wanted to make sure to ask you as a physician, you know, when it comes to PrEP and, you know, women using PrEP, just to have, you know, address this question. Is there any particular concern, whether it's a daily pill or injectables, with women taking PrEP versus non-cisgender women.

Yes, the biology of it is very important for us to understand, when it comes to HIV contraction, anal sex and vaginal sex are very important because of the way that these medications work and the concentration that, are needed in these specific tissues. With women in particular, the vaginal sex, if you– the vaginal tissue, the mucosa of the vaginal tissue, it's a little bit harder to penetrate on some of the oral medications and a patient– women need much more of a better adherence in order to get that major protection that they get.

So that's what we saw on the clinical trials of the oral medications, like, FTC and F/TAF, women needed a higher intake of that medication. And, and it is interesting to see I always get surprised when I see the clinical data. When women were being studied for PrEP to realize or to know that women, unfortunately, were not as adherent as men were.

Which actually, as I just explained to you, that they are the one particular, patients or group of community that needs to be much more adherent in order for oral PrEP to be effective. So when you have now these long acting medications and that's how you see the impressive superiority with women compared to men because then we're not relying on the intake of the medications by the patient every– on a daily basis but you are only just giving the shot, and that's it. You don't have to worry about that because you need to come back for your next shot in– whatever long-acting is the one that you're taking at the current time. We only have one long-acting, which is cabotegravir, and you do it every two months. But there is like new things coming up on the pipeline that would be giving, longer shots up to like four or even six months, sometimes even a year coming.

So this is a very, very important, topic of research right now for HIV prevention, because when we overcome that need of compliance of the medication, and we have such success– successful new medications, long-acting medications to give to the patient and to get, protection against the HIV, it's going to be a game changer for the control of the HIV epidemic.

And that's our goal. That's what we do as HIV providers is the number one goal is avoiding infections. We have these tools that are very successful to control HIV. So like we definitely want them to provide them the best of care. So one HIV infection is too much infections, we, we want zero infections.

David: And to make sure that people are aware, who are listening may be interested. Cabotegravir. Is that currently available for anyone to access in the US, do we know?

Dr. Pardo: Correct.

David: And would you, would you suggest that I mean if, if it, you know, the daily pill was, really a more accessible option or more affordable option, would you suggest that in that case, you think it would still be effective for women?

Dr. Pardo: It’s definitely effective, you just need to really enhance the need of like, make the message of like, the real need of like good compliance. [David: Sure, sure.] Specifically in the women population. But yeah, like, the data shows that definitely long-acting has been way more successful. But it’s actually in both men and women.

But all of that just comes, not that because one works best or is best than the other, but it is more so because of the compliance, the compliance of the medication. And then we see that on clinical trials. There still could be rare breakthrough infections with the use of these medications, but they're definitely rare. As long as the patient has come, I see this is scheduled for their shots and or they’re taking their medications well. And then these medications are still regarded as highly efficacious and very safe.

David: Yeah. And I remember too, I wanted to make sure that we ask about, that you had gone to CROI recently if you could just, you know, help, you know, listeners understand what that conference is. And, you know, maybe some of the, you know, things that really stood out to you when you were there, some of the exciting things happening.

Dr. Pardo: There's a lot of exciting things for sure happening on HIV. One of them on HIV medicine. [David: Sure.] There's a lot coming for prevention and a lot coming for treatment. For prevention, I was just stating a little bit of, like, there's a new medication called lenacapavir that is coming that is going to be a shot every, every six months. We expect and hope that it's approved by the FDA in June.

That's the hopes that we have, a very compelling data where there was, in women, actually the very first PrEP medication, but it has zero infections, no infections, no HIV background infections in over almost 2000 women that were included. Yes, they were all in sub-Saharan Africa. They are doing a study right now on lenacapavir specifically for U.S women, because that's a niche that we do definitely need to do.

You know, like sub-Saharan Africa have their own statistics. And then we definitely need to study different regions. So we want to and need to have the studies done in American women to see if that also translate as good as like it translate in sub-Saharan Africa. But we expect it to, to be that way, so that's upcoming.

There's actually also for those who would be like– and this is something very important because it actually happens on on gay men. Something like well, you know, when you, when you come to the patient, they’re like, “I am sexually active but not that sexually active. Why do I want to be on this medication every day or like getting a shot wouldn't it just be running around my system.”

So in gay men we use something that is called PrEP on demand and it's called 211. And for those patients that I usually tell like have less than two three sexual encounters per month, then you can do that as a strategy. So and that's actually called with TDF, F3TC, which is which is known as the name Truvada. It’s generic now.

But now there's also research of studies specifically knowing for PrEP on demand, specifically for women. And because we know when I explained to you the, the biology of the access of these drugs into the vaginal tissue, but they're starting to do PrEP on demand on women, but doing like instead of 2-1-1 will be 2-2-2.

So it will be higher doses. So two tablets, every day. So before the sexual encounter and then two more for a couple of, like, more like three more days, 3 or 4 more days. So that's data that's still being collected to see if it's as efficacious. So that is helpful because we need options. You know, when you go to a restaurant, the more options you have the happier you are.

So we are studying that. So like I think that is an important niche of research to know and give an option also to women who, who don't feel that they're at a risk as much and they don't want to be on a medication all the time. So that's the exciting thing that is happening about, PrEP right now for women.

There is newer medications, new capsid inhibitors, also like, one pill a month only. So that also everything is studied in both but then the, the studies for PrEP need to– definitely one is for cisgender women. I know that one is usually designed for men who have sex with men and transgender woman because of vaginal versus rectal tissue, but those medications are studied for both men. And yeah, we need options. And then the options are coming.

David: Okay! That's all really exciting. And I saw you nodding couple of times. It sounds like those are maybe some, some trials and some, some new things coming down the line that you all have been familiar with in a scope of research, too. 

Erica: Yeah, definitely. The lenacapovir study, we are a part of, their MSM study, but we received a lot of clinical data from their original study, which was done in Africa. and cis women. And the data looked very promising. The adherence for oral medication was very low and the success rate for the injection was very high. And I believe it was around 4000 women that they tested this lenacapavir on. And a lot of positive reports came back from the original study.

David: What do you think as far as the patients that you have here in L.A and in the U.S or, you know, trial participants, I should say, you know, what are some of the most promising things that you're seeing as far as when people get engaged with clinical trials, what kind of difference do you think that makes and, and their attitude toward HIV? I mean, what kind of a change do you see happen for people that, you know, get involved in this way?

Erica: I think, the biggest thing is awareness. Being presented with information about HIV and the risks of HIV. I think that is really huge. And then also it brings up a curiosity of other, infectious diseases or just their health in general. With clinical trials we do a bunch of labs and safety labs and a lot of our participants will come in for their follow-ups and they're like, “Oh, I didn't know this level, this, certain level’s high. I should go see my PCP,” and it almost reinforces, a positive outlook on getting care.

And I think it's a huge step into almost in a way to self-care and making that step to, “This is an important medication that I should be taking, and it's like a route towards self-care.” And it also helps with the bunch of barriers. Clinical trials, a lot of clinical trials will offer stipends, Lyft rides.

So some women, or men in general, they don't have access to healthcare. So it's a great route to, get the basics of your healthcare and a way to monitor it.

David: Sure. That's wonderful to hear, too. It seems like it can really make a difference in people's lives going forward in their health. From that point on, what, what have you seen Ashley?

Ashley: I've seen a lot of the same things. I think one of the main ones is also like the barriers to care. It kind of eliminates a lot of those, and they're able to work with people a lot more than like a regular clinic would be, just because they like to help, to help people get to their research visits.

They help along with the stipends. And you don't need insurance to be in research, which is a big one. So a lot of the population that's uninsured and wouldn't be able to get care otherwise, research is a good option to kind of look into for them to see if there's anything they're interested in, because they can kind of take out that stress of, like, “How am I going to get my medications?

How am I going to be safe when I can't afford to pay for all of these?” Because without insurance, like HIV medication, all of that is pretty expensive. And there's programs that will help you sometimes get it. But research is always a good option for them if not. And then as well as– during your research visits, we usually have a lot of time and we can kind of set aside a bigger chunk of time to sit down and talk with them, make sure that they have any questions that they have, answered, and they have a chance to talk with a doctor every time they come in, too.

So, most visits, they'll get a physical, especially if they have anything new come up or any new health issues. So they get direct access to a doctor, and then they get a lot more frequent labs than they usually would go into like our regular clinic just because it is a research trial and we want to get more data like that and make sure everything looks okay and make sure everything is going well for them. So you get to see a lot of different labs that you wouldn't normally get that often too, which is kind of nice.

David: How long does that process usually take?

Ashley: Some trials are with a year, but some trials can be up to two years. Like I think our PrEP study’s going on two years right now almost. Yeah, I think our lenacapavir study, I think we're hitting the three year mark.

Ashley: And that's depending on the phases too. So like phase one studies maybe a little bit shorter. And you might take, a different dosage of it and you may only take it once. And then you phase out of the study. Phase two studies may be a little bit longer. And then phase three is usually the last phase where after that it gets to go to the FDA. And during the time where you're waiting for the FDA to either approve or reject it, most of those studies will allow you to stay on the medication and come in about every three months, is what I've seen just for routine visits to get labs done, check in with your doctor and get the medication so that you can remain on it. You, you don't have to switch back to another one while you're waiting for it to be either approved or rejected.

David: Oh, great. Doctor Pardo, in what instances would you recommend for folks like patients that you see become involved in a clinical trial?

Dr. Pardo: Because we have the pulse of what's going on here, particularly in an organization. Then we tell them, what– if there is an availability within that as a candidate. Like, any research protocol has like the inclusion and exclusion criteria. So we are, aware of what's going on.

And then we, identify, any, any person who is a good candidate for– as a participant, then we– and if they're ready to volunteer, it's a very altruistic way to when you really put a research participant, because it really helps to build up science and build up the knowledge that we do have.

So, so if we see that there is a person, a person who can, who was willing to participate and is willing to answer the specific question, that is something that you really want to address. What is the scientific question that we do have that you want us to help us address, and then making them understand that they also will get a benefit out of it, we hope, and we expect, then that's what we address on identifying this subjects to be clear on research.

David: Oh, you know, I think one of the things that really stands out to me right now that I want to make sure that I ask is, you know what do you think is coming up next as far as where we're at in the US, as far as availability for HIV care? You know, what are some of the suggestions you might have for people to make sure that they are, you know, getting the access to the care that they need?

David: What are some of the issues, maybe that are on your radar, for access to care for women, maybe specifically for HIV or, you know, medical care in general?

Erica: With our Rapid Results clinic, I've seen a lot of participants come in just for routine STI checkups and emphasis on if you're sexually active, routine checkups. And then during those visits at Rapid Results they receive a lot of education from the provider and they'll do routine testing.

Also if they are, if they identify any risk factors for HIV, then the discussion of PrEP comes in and then participants or patients that are on medication, they get to stay up to date, with their– with any new medications that are developing. So I think yeah awareness is huge in that.

David: Mhm. Ashley?

Ashley: I think, it's important also that the foundation really creates like a safe space for women to come in. Like it may be named the Men’s Health Foundation. But to always emphasize that, like, everybody is welcomed here. And I think especially with everything going on, it's really important that women and everybody feel safe going and talking to their healthcare provider and being honest.

It's so important to be able to be open and honest with your provider when you talk to them, because if you withhold something important, it can really, like set you into like a dangerous area where you might not get diagnosed with something that you could possibly have, you might not be able to get the proper treatment because they're not aware of what– everything that's going on.

So I think that's one of like the main important things I would say is just, that they're able to feel safe and feel like they can talk to the people where they're going at the healthcare facility that they're getting care at. And I think Men’s Health Foundation is great for that. I mean, I've seen so many people come into Rapid Results and then end up getting linked into care, like helping them get insurance.

We have so many programs here that, like, help them with each step of the way to get to where they need to be. I think that's like cutting out a lot of the barriers, too. I mean, we have assistance with like, Lyft rides. I've seen to the primary care for some people, they have so many and they help you with anything that they can. So they, like, walk you through each little step of the way so it doesn't really just stop at like, “I hope you can get help,” like, send you out. [David: Right.] They're very involved in getting you in and making sure that you are taken care of and that you understand everything very well and that you feel safe where you're at. So I think that's a great one for, for here.

David: Oh yeah. And Dr. Pardo on your side, on the clinic side and as a physician, have you seen the same thing as far as just the importance of, patients feeling safe so that they can, you know, share all of their concerns in a judgment environment? And do you think that at Men’s Health Foundation, have you seen that more than in other places?

Dr. Pardo: 100%. And that's actually one of the successes that we have as as an organization and I want to publicly, thank, you know, Erica and Ashley for being part of the face of the organization because, as I said before, it used to be kind of like a, just like a “gay men's problem” in America. But that's really not the case. And the fact that you can identify with women, with a gay man with a color doctor and or woman of the same gender, that actually gives, like, a significant latch onto, like, safety and a sense of connection.

And, just like you are, definitely empowering women to seek care, in this organization, I was about to say yeah we need the “W-O” there in front of the “Men’s Health”. [Laughter] Because we, we, look, I will tell you this. There– in all of the fields of medicine, there is not a field where you are going to see on HIV medicine, the most important that we do care of not leaving any community behind. And that comes again with all of the clinical trials are intrinsically important that they include every single population. Man, woman, women of color.

We had that woman of color, transgender woman, gay man, cisgender woman, all of us, because we meet– all of us are actually at risk. So, so we need to understand everything. And we, we– one of the things that we had at the beginning, back in the 90s, a lot of the patients were mostly white men, and that's it.

But that has really changed. And there's been, a significant push and a need and a must that we should enroll diverse population because we need the data from that. We cannot just extrapolate from one population to another. It's not fair and it's not safe. So science comes from truth and the bridge to that is, these clinical trials and creating these large, expensive trials.

But there's actually what actually gives us like the real information so we can actually give some little bit augmentations to, to our patients. So that's, that's the biggest point. And to your point of like what else can we do as an organization to provide that is, you know, like access to these programs and then engage them in care is very important to see that we are interested in their well-being.

It is important. And, I don't want to sound grim with what I'm about to say, but we live in a reality with, this is extreme anxiety of what's going on with the administration, where a lot of these programs may be in jeopardy because they do not believe on the diversity, the equity and inclusion. And when that happens, all our community is put at risk, because when you do not put patients in care for either HIV treatment and/or, for PrEP, for prevention, then I don't need to tell you what's going to happen.

I mean, the rise of the, morbidity and mortality, new infections with HIV and/or people who are, with HIV or will have like, an advancement of the disease and that will be so detrimental. So like so I will– my message to this, to the, to the audience, is don't be fearful of, like, asking for care.

And this is a safe space, and fight for what you need and what you want and what your rights are. And then health is going to be like, blanketed right for absolutely everyone, no matter colors, genders, race, political, static, nothing. Everyone should be the right to help. So like, you see us as a, as a friendly foundation that wants just the best for you, and, fight for your rights. We need to resist.

Erica: You are your biggest advocate. and with that does come with a lot of weight. Just know that there are a lot of providers who are right next to you supporting you, there are a lot of programs out there. Not just, specifically, our foundation, but many other facilities that are wanting to help out.

And, you just need to take that first step and seek either a PCP, regular checking for STIs, anything like that. But there's a lot of people in the medical community that want and will support you through anything, health-related.

Ashley: Yeah. I agree with that too. I think, one of the main things is like the barriers to getting care are very real, and people know that. Healthccare workers know that. And if they don't, they should. But I think one of the main things to keep in mind is stigma really sets people back from getting care. Stigma is very it's very dangerous. It can be life- threatening. It can create large gaps in health care and I think one of the main things that people need to remember is just stigma is real.

And as a healthcare provider, I think it's kind of your job to educate yourselves and combat stigma with proper education, making sure people know the real facts, making sure that people feel safe coming to your space and coming to talk to you and see you. And they don't withhold information, Yeah, and I think with patients, when you go see your provider, if you have one, I think just remember to advocate for yourself like that and don't let the stigma stop you from seeking the care that you need.

Obviously, like, everyone's health is the most important thing so you can't let stigma keep you from getting your health in check.

David: Well, Erica, Ashley, Dr. Pardo, thank you all so much for what you do. Thank you for what you've advocated for here today and the resources you're providing. Any last words before we wrap up?

Erica: Thank you for having us and we look forward to all the new medications and programs to help build awareness around HIV.

Dr. Pardo: Yeah, I will say the same thing. Thank you again, both of you, for all of you putting this together. And, to the audience again, like, you know, it takes two to tango and we, we are good dancers, so we're ready for you. You just have to, what you were saying, patients need– what they need to do is drop the stigma, drop the shame, drop the fear.

Come here and get the knowledge. We have options for you and come and get tested. Get treated. Engagement in care, this is all for your health. Nothing else. You do you but you really have to step up, get out of that chair of shame and embarrassment and just lead a healthy life and we want you to live it and thrive with it.

So that's message to the audience, my– get up and, get up and dance.

David: Thank you all so much.