Evidence-Based Gender-Affirming Care for Young Adults with Robert Garofalo, MD, MPH

Erin Spain, MS [00:00:10] This is Breakthroughs, a podcast from Northwestern University Feinberg School of Medicine. I'm Erin Spain, host of the show. Providing evidence-based medical care to transgender and gender nonconforming youth has been a challenge in the past, as trans-related healthcare has long been understudied. But that's changing. Today's guest has published several papers on this topic and has been awarded grants by the NIH to look at long-term and short-term outcomes of youth who have transitioned. Dr. Robert Garofalo joins me today to talk about his research and how gender-affirming care can improve the overall health and well-being of gender diverse children and adolescents. He is the Potocsnak Family Professor in Adolescent and Young Adult Medicine, Chief of Adolescent Medicine in the Department of Pediatrics, and a Professor of Preventive Medicine here at Feinberg. He is also a pediatrician at the Ann and Robert H. Lurie Children's Hospital of Chicago and director of the Gender, Sexuality and HIV Prevention Center at Lurie Children's. Welcome to the show.
 
Robert Garofalo, MD [00:01:22] Thank you so much for having me.
 
Erin Spain, MS [00:01:23] Your clinical and research interests focus on marginalized youth populations, including HIV positive and the LGBTQ community. But your work is also highly dedicated to the health and well-being of gender nonconforming and transgender adolescents and youth. Tell me more about the scope of your work as both a scientist and a clinician.
 
Robert Garofalo, MD [00:01:44] My career to some extent has been a bit of an evolution, right? I started out my career -- I don't want to date myself, but, you know, twenty plus years ago at Lurie with a real focus on wanting to do work both clinical, programmatic and research related to the health and well-being of LGBTQ youth. You know, and that led me originally to doing a lot of work around HIV positive youth and developing programs here in Chicago like the Broadway Youth Center and really having a focus mostly on programmatic efforts and really clinical work. And I learned early on that if I wanted to keep myself funded and happy, that balancing that with doing some academic research in those areas would be important. Honestly, my work with trans young people really grew out of a career doing work related to adolescents living with and affected by HIV. You know, more and more I was seeing very young women, particularly trans women, mostly from communities of color, black and brown trans women who were acquiring HIV. And it had gotten to the point where if I had to give one more HIV diagnosis to a young trans woman, I was going to lose my mind. And so I began to think with some colleagues about what are some structural things that we could do differently. And I firmly believe that gender-affirming care for younger, you know, gender diverse children and adolescents saves lives. And so I began to get an interest in doing this work, not just clinically, but adding to a research base because it was largely lacking. And so it really was my interest in HIV that really grew to having a more holistic view of a population that really was not being well-served in some ways by being seen only through an HIV lens, right? And it was by taking a step back and being like, what are the things we could do to change the course of these children and these young people's lives in a way that would be meaningful and supportive. And for me, that really boiled down to gender-affirming care, like providing them access to an ability to live their lives as their authentic selves earlier in life as opposed to later, that I believed then and I believe now saves lives.
 
Erin Spain, MS [00:03:52] I want to talk about some of the terminology that we're using. gender-affirming care, transgender, gender diverse. Just take me through some of these terms for our listeners.
 
Robert Garofalo, MD [00:04:02] Yeah. So transgender is a term that describes someone whose gender identity does not match the sex that they were assigned or affirmed at birth. And when I say gender versus sex, sex is largely a term that's defined by anatomical parts, right? And I'm oversimplifying it because they, too, are not necessarily binary. And there's lots of variation in the human condition. But if you're born with a penis, you're often assigned or ascribed to male sex. And if you're born with a vagina, you're often assigned or ascribed to a female sex. But your internal sense of who you are as a person authentically, your gender can either match that assigned sexual identity or not. And for transgender people, their gender identity is discordant or does not match their sex assigned at birth. Gender diverse, I think, really just applies to an understanding that these conditions are not affectations, right? These are not disorders. There's a diversity in gender expression. There's a diversity in sexual expression that I think is aligned with the human condition in a way that it's important to describe gender in a way that, again, is not binary, is not seen in any way as a pathology, but is really seen within the context of some sort of normal humanity and normal human expression. Gender-affirming care -- I mean, I suspect we'll get into this when we start talking about, sadly, the legislation that's currently at play across the United States. But gender-affirming care is honestly the care that anybody would want their child to receive if their child was having gender dysphoria or discomfort related to their gender identity. And what gender-affirming care is really taking a step back. And I just call it good pediatric care. It's really taking a step back and listening to families and listening to a child and providing them the care, the mental health support, the type of holistic services that really affirm them as who they are in their bodies and in their family identities and in their communities.
 
Erin Spain, MS [00:06:01] You mentioned already you got into working with this population through HIV positive patients, but there are many different health issues facing transgender youth. They're a vulnerable population. Can you walk me through some of those?
 
Robert Garofalo, MD [00:06:16] Yeah. I mean, first and foremost, you know, I like to see these young people through an assets model as opposed to a deficit model, right? Transgender adolescents are no different in many ways than other teens, except that they have to deal with a tremendous amount of societal pressure growing up in a world or in communities or sometimes in families that are not affirming or not supportive. And so the health disparities that we see in this community are largely a result of that societal stigma or, you know, what it means to grow up as an adolescent in a challenging or unsupportive environment. And so oftentimes, they are seen through this lens of mental health and substance use or HIV or they're often at risk of homelessness. You know, there's many sorts of deficits. And I like to flip that spectrum of dysfunction and think of it through a different spectrum. I think in many cases, these young people are resilient and strong and powerful. And so I always start off by saying that, you know, that there's a misconception of transgender youth as all being a risk of a good number of health disparities. That said, those health disparities are real, right? There are still far too many young transgender people that are at risk of acquiring HIV. There are still far too many that consider harming themselves or attempt to commit suicide. There are still far too many that find themselves living on the streets. And so these are realities that I don't make light of. I just think it's really important when we have a discussion of communities that we also tell the truth about the very many strengths that these young people have. And to me, honestly, you know, I've had a pretty long career. I'm not quite done yet, but I don't know that I've ever met a population of young people that have impressed me as the young, gender diverse children or transgender adolescents in terms of how resilient and kind and empathic and really wonderful they are, despite the many challenges that they face around them. I mean, I'm a storyteller by nature, and I could tell many stories about ways that young transgender adolescents have just stunned me sometimes in a clinical setting about just the way that they view the world that is optimistic and hopeful. I mean, you can't help but have discussions about very real health disparities. But I also just like to remind folks that many of these young people are going to change the world in some amazing ways that we can't even imagine.
 
Erin Spain, MS [00:08:47] Providing evidence-based care for these young people is really important, and that's been difficult to do in the past because this population was overlooked for so long. Tell me about the history there and what's been happening recently.
 
Robert Garofalo, MD [00:09:01] Yeah, I mean, you're correct in that this has been a largely overlooked population. And I would say that for many years, I think the care of these children and adolescents occurred kind of in the shadows, right? Many of these programs were kind of allowed to exist but on the margins and on the fringe. And one of the things that I'm actually most proud of, and this is kind of unrelated to your question, but I'm going to go there anyway, is there is the role that Lurie and Northwestern has played in many ways in defining this discipline. You know, our program really got a jump start from a philanthropic partnership with, you know, Colonel Jennifer Pritzker and the Tawani Foundation. And were it not for that investment from a community partner, I'm not sure, you know, how Lurie or Northwestern would have proceeded with this program. But having that partnership was really meaningful in terms of taking this discipline out of the shadows, right? So from the onset of our program at Northwestern at Lurie, there was a pride in the work that we were doing in a way that was novel and sort of remarkable and I think set the bar higher for other people doing this work. And so in the early days, I had families that were driving 8 to 10 hours to see me for care, you know, because there was no access. You know, when we first started our program, there were maybe a handful of programs. We were the first in the Midwest. But now, you know, I'm pleased to say that, you know, these programs exist in many children's hospitals and facilities across the country. And in terms of the evidence base, you know, it's a challenge. I mean, for many years, the only evidence that was coming out of this space was coming from the Dutch or from European teams. And I think while that research was seminal and incredibly important, it also had limitations, you know, and just a few of them are, you know, many of the things that need to be studied are about the social context of the interventions that we're doing. What is it like to provide gender-affirming hormones to a young person that lives on the south side of Chicago as opposed to the north side or, you know, that lives in a suburb as opposed to an urban environment. What are the cultural and social implications of blocking puberty, you know, for a number of years while it's safe to proceed down a different pathway with gender-affirming hormones? And so it is a discipline where the evidence base is now being assembled, both here in the United States and elsewhere around the world with some consistency. But it's truly lagging behind, I think, in some ways, clinical models and clinical care. You know, this work has been being done with empirical models of care for many years and being done safely. But only now, I think, are we really beginning to do the type of research where we're looking at short, medium and long-term outcomes of the care that we are providing in a way that I think hopefully will be either reassuring to institutions and families and patients or also will shed a light on things that we can be doing better.
 
Erin Spain, MS [00:11:58] Tell me about in 2015, the National Institutes of Health awarded this $5.7 million, five-year multicenter study that you were a part of to evaluate the short- and long-term outcomes of the medical treatment. This was a pretty significant award that the NIH gave out at the time. Tell me about that.
 
Robert Garofalo, MD [00:12:15] Yeah, I mean, it's significant even now. I mean, it's still to date, the only, I think, NIH-funded cohort longitudinal you know, it's an observational trial. It's four sites: Boston Children's Hospital, Children's Hospital, Los Angeles, University of California, San Francisco and Northwestern and Lurie Children's. And it was a seminal study back then and continues to be a seminal study now, looking at a whole range of medical and psychosocial outcomes of the care that we provide. And, you know, it's not a randomized, it's not a controlled trial, which I think is a misconception. There would be a lot of ethical concerns about how you do a traditional randomized controlled trial. It would be impossible. So each of these sites embarked on -- and we each had very different models of care, but we each embarked on an observational trial to begin to fill the evidence gap that existed in the literature. And so I'm very proud of this work. It's probably one of the most important pieces of research and grantsmanship that I've ever done. I'm also very proud of the NIH for supporting this work and continuing to support it. We were just refunded last year for an additional five years. So we have two cohorts in the trial, or two plus, two and a half. We have a cohort that's starting pubertal blockers, you know, what are known in the late process are puberty blockers or GNRH agonists. And then we have another cohort of older adolescents that are starting gender-affirming hormones. And some of the contributions that it's making, as an example, is going back to the European or Dutch cohorts. Like their model of care, because of the way young people enter puberty, you know, in the Netherlands or in Europe was very different than here in the United States. You know, young women, sex assigned female at birth, often enter puberty at very young ages, you know, in the in the United States, 9, 10. That's an age when if you're progressing through an undesired puberty, that can be extremely disconcerting and create problems around some of the mental health issues that we talked about, self-harm, psychological distress. And so our study began to enroll people younger than the age of 12, really on pubertal blockers and then studying, I think, in a very careful, scientifically driven and methodical way the safety and other medical outcomes of the interventions that we are using. You know, I like to think of it as dipping our toes in the water. I mean, I personally would love to see the NIH, you know, fund a network of sites across the country that are doing this research. It's with a tremendous amount of gratitude for, you know, for their investment in our work, but also with a critical lens saying a lot more is needed, you know, to really understand models of care to understand impacts on diverse communities of transgender youth. There are limitations to our current study. We've struggled as an example to enroll black, trans feminine identified young people. And so if you think about the original premise of the grant that I described earlier. My interest in doing this work is that I believe early medical treatment will change the trajectory of transgender young people's lives, right? Will eliminate health disparities. Well, if we're going to look at these interventions through a health disparities lens, then the population most at risk of health disparities is black transgender women, right? They're the ones that are being highly victimized and being victims of violence. You know, they're the ones that are most at risk of acquiring HIV. And yet in pediatric gender programs across the country, and I don't mean just here at Northwestern and Lurie, that's a population that has to-date been elusive even in our early cohort trials. So, you know, again, I'm super proud of the research that we're doing. It's ongoing, it's important. It's scientifically grounded, but there's still so much more that needs to be answered and needs to be done.
 
Erin Spain, MS [00:16:12] One of the projects that came out of that NIH grant, you looked at the various effects of hormone treatments on the body, including effects on cholesterol. Tell me about those results.
 
Robert Garofalo, MD [00:16:21] They're in their early stages, to be honest, right? So we just finished following our cohorts, our original cohorts for 1 to 2 years. What we found is that at least at baseline, transgender young people had much the same, you know, largely the same sort of metabolic issues as other adolescents. The importance of this work, whether it's on things like cholesterol or, you know, bone mineral density, is another one that's a very hot topic in this field. So, you know, again, really understand, are there implications to the treatments that we are providing young people? I mean, I'm pleased to say that thus far, and I'm painting a complex condition with a very broad stroke here, but by and large, I think what we're thus far finding is that these interventions can be done and used safely with children and adolescents. Again, I think there are, you know, many more topics that need to be looked at and addressed, particularly with some more diverse communities, which we've already talked about. But I think that paper was really looking at the sort of metabolic characteristics of these young people. And at least at an initial look, it didn't look like that the adolescents were that much different than their peers.
 
Erin Spain, MS [00:17:33] Another important study that you recently published has to do with young adults who identify as transgender, who want their preferred names and pronouns documented in the electronic medical record. Tell me about this study and why this is so essential to the gender-affirming approach of care.
 
Robert Garofalo, MD [00:17:50] I served as the mentor on this study, really. And Gina Sequeira, who's now at Seattle Children's, took the lead on that while she was an adolescent medicine fellow at the University of Pittsburgh. And so I hope that I was helpful for Gina and this very sort of important study, which really just began to document how important it was for young people, even in the electronic medical record, to be affirmed or seen as their authentic selves and how disconcerting it was for a young person or a family member to be misgendered or to be called a name that is inconsistent with their sort of current identity. And it's I mean, in some ways it's very self-evident, right? I mean, if you or I, and I'm making assumptions about your own gender, but if you or I were misgendered in a medical environment, it would be upsetting and disconcerting. And it's even more so, I think, for trans young people who really struggle to be seen for who they are. And so, you know, for gender-affirming care, it tells us a lot about the types of models of care that we need to ascribe to and the complexity of it. One of the things that's important to recognize is a) How complex the healthcare system is, and if we really want to affirm young people or any person in this space as trans identified, then we have to really think broadly about how we utilize systems like an EMR. But I think it was also really important for me to just see how much this is not a static thing. It requires constant reevaluation by our team to think through how our systems at Lurie Children's and Northwestern can best be designed to make sure that people are feeling supported and affirmed in all aspects of their exposure, you know, and that's from the security guard to the person that answers the phone. You know, it can be that challenging, right? And I and I used to say, by the time an adolescent gets into the exam room, they have already decided whether this is a safe space, right? The most important people in establishing safety are the people that these young people meet when they walk through the door, the security guard, the medical assistant, the person that checks them in at the front desk. Like that study really detailed how important pronouns and authenticity, affirming authenticity was in the lives of these young people.
 
Erin Spain, MS [00:20:09] There are legislative obstacles related to gender-affirming care and models of care, and your research really can serve as a counterargument to these obstacles. Tell me why this is such an important matter.
 
Robert Garofalo, MD [00:20:23] These legislative efforts which mischaracterize the type of care that we're providing, they describe gender-affirming care as like hormones on demand, which it's not. They imply that we're providing gender-affirming care to pre pubertal children, which we are not. You know, there's all sorts of misconceptions in those legislative efforts. And at their core, they are anti-science, they are anti-public health. And honestly, they run against simple codes of human decency, in my opinion. You know, transgender young people and their families deserve far more than what they're currently getting from some of these legislative efforts. I'm grateful to be living in a state like Illinois and to be in a place like Lurie Children's at Northwestern, where I don't fear that tomorrow I'm going to wake up and have the type of care that I know saves lives restricted or, God forbid, banned. But there are now, you know, 29, 30 states where these efforts are moving forward rapidly, if not having already been approved. And what's behind them is nothing more than a power play around political clout rather than an investment in these young people and their families. There is universal support for gender-affirming care from every mainstream U.S. based medical society that I can think of: the AMA, the APA, the AAP. I mean, these organizations never agree with one another. And there is uniformity and solidarity behind the importance of gender-affirming care in the lives of these young people. What I wish for these legislators is to actually take the time to meet some of these transgender young people and their families, because I think nothing can open up hearts and minds better than taking time and really getting to know some of these people. And again, I'm so grateful for the leadership of Lurie Children's and at Northwestern for supporting this work full-throatedly, because there really is no question that this is in the best interests of children and families.
 
Erin Spain, MS [00:22:21] Well, thank you so much for coming on the show and sharing what you've been doing, talking about the current state of things. We really appreciate your time today.
 
Robert Garofalo, MD [00:22:29] I appreciate the opportunity to be able to dispel some of the myths and really talk about the truths behind who we are and what we do. Because I think sometimes the people that are yelling the loudest are on the opposite side of that debate. And in order to balance that out, I think people like myself and people that do this work, wedded in a belief in the scientific process, have to be able to speak out. And so I appreciate this opportunity.
 
Erin Spain, MS [00:23:05] Thanks for listening. And be sure to subscribe to this show on Apple Podcasts or wherever you listen to podcasts, and rate and review us. Also for medical professionals, this episode of Breakthroughs is available for CME Credit. Go to our website, Feinberg.Northwestern.edu and search CME.