The Adolescent Trials Network led the way on HIV research for young people—until it was shutdown. A conversation with the two lead researchers of the now-defunct ATN, Sybil Hosek, PhD, and Lisa Hightow-Weidman, MD, MPH
Since 2001, the Adolescent Medicine Trials Network for HIV Interventions, known as the ATN, had brought together doctors, researchers and community organizations to address HIV and co-existing conditions affect adolescents and young people. Their work led to evidence-based interventions addressing adherence, mental health, substance use, digital health and HIV prevention. ATN’s clinical studies led to the FDA’s approval of PrEP for adolescents under age 18, and they were starting work on doxy-PEP as STI prevention for young women. All that came to an abrupt end on Friday afternoon, March 21.
That’s when the ATN’s principal investigators, Sybil Hosek, PhD, a professor at the University of Illinois at Chicago, and Lisa Hightow-Weidman, MD, MPH, professor at Florida State University, received a termination letter from the National Institutes of Health’s Office of Extramural Research. The letter not only told them that the ATN had come to an end, it dismissed the value of reseachers’ work.
Drs. Hosek and Hightow-Weidman spoke with POSITIVELY AWARE via Zoom to discuss their work at the ATN, the termination letter and its aftermath.
The day the letter came, what were you doing?
Lisa Hightow-Weidman, MD, MPH
Lisa Hightow-Weidman, MD, MPH: I was at a faculty meeting at Florida State, and I got a call from my vice president for Research. Her voice was shaking. She said, They terminated your award. I said, Which one? She said, The big one. I haven’t seen the letter yet, but they called me, and I had to call you right away. And I just sort of froze and tried to call Sybil—who didn’t pick up the phone...
Sybil Hosek, PhD
Sybil Hosek, PhD: So, I had taken the day off to spend with my adolescent son watching March Madness basketball. And then I looked down at my phone and it was... Lisa never calls. We’re digital communicators. So I thought, Oh my God. She told me, and I just started screaming. Lisa was so quiet, just stunned, that I'm yelling. And I just, I couldn't believe it. When I hung up, I just broke down crying. I had been riding high on anxiety for a long time, seeing what was happening and anticipating that maybe they would ask us to change some of our grants, change some of the studies, but [that they’d] work with us. We had no idea that the entire network and all of the infrastructure that has been built over 20 years would be canceled.
What’s some of the work or studies that’s been canceled?
Dr. Hightow-Weidman: We have seven studies, three of which were active and and the other four were in the process of being started this calendar year—one, next month then another the next month. Our studies align pretty explicitly with President Trump’s 2019 End the [HIV] Epidemic initiative [known as EHE], and we have studies that address all areas of the prevention and care cascade. We have a study that’s focused on increasing awareness of HIV among adolescents and young adults who are seen in the pediatric emergency department using integration into the EHR [electronic health records] and a clinical decision tool. We have two studies that focus on making PrEP more accessible and improving adherence among adolescents and young adults, getting rid of some of the structural logistical barriers to PrEP.
Another, using digital health tools to help young people make autonomous decisions around PrEP. We have a study that’s focused on young women and multi-purpose technology—a combination of pregnancy prevention and HIV prevention technologies. We have another study that’s focused on addressing stimulant use and its contribution to HIV, risk for acquisition and transmission to zero, a status neutral protocol focused on young men who use stimulants, including meth, cocaine, GHB or ADHD medications that are not prescribed—that study was active and enrolling.
We have study participants who are currently not going to be receiving the kind of evidence-based behavioral intervention that we enrolled them for. Our last study was a doxy-PEP study. It would be the first randomized controlled clinical trial assessing doxy doxycycline, post-exposure prophylaxis in adolescent and young adult women, girls, in the U.S. That study was poised at changing policy around the use of doxy-PEP for girls and women. We had additional studies, including using lenacapavir in adolescents and young adults that we were going to incorporate into a new protocol, some additional work on cardiovascular outcomes. The network was poised to bring this new science forward.
You mentioned the infrastructure. How many sites and how many people are in the ATN?
Dr. Hosek: We have 12 clinical sites that are brick and mortar, but those are also embedded in what we call community coalitions. It’s not just the clinical site, but all of the community-based partners that they work with, and that might be service organizations, youth organizations, the Department of Public Health, whatever, in each of those in each of those cities. And then we have digital sites, which were able to reach folks who don’t have an ATN site that’s near them, but that would benefit from being in the trials. We enroll them virtually into several of our protocols. We have over 200 people who are drawing a salary from the ATN, and they're found in over 20 states, but it not just those people; I imagine that they have staff under them that will also lose their jobs.
What are your feelings now?
Dr. Hightow-Weidman: We’re devastated. It feels like a death. I can only compare this to... the only feeling... I’m gonna cry. The only feeling I’ve had like this was when my father died; just that overwhelming grief that doesn't go away. Sorry...
No, no, no... I’m sorry. I’m sorry for asking...
Dr. Hosek: Lisa and I have made the ATN our home. We both started in it as early investigators, I just had my PhD, she was coming out of med school. We were early investigators; we found our passion here and have stuck with it and now are able to lead it. To us, it’s family, it’s a home.
The letter itself, the wording was...
Dr. Hightow-Weidman: ...incorrect... insulting...
Dr. Hosek: ...It’s wrong.
Where did the wording come from? What was that about?
Dr. Hightow-Weidman: This is the same letter that everyone has been getting. I think that it’s an agglomeration of words that don’t mean anything but are hard to refute because there’s no meaning in it. They’re saying that we’re not doing science right. They’re saying that it’s amorphous equity work. I don’t know what that means. ChatGPT couldn’t tell me exactly what that meant. They’re saying that the work has no value to any living system. That’s frankly not true.
They say it’s a drain on taxpayer money. The prevention of every HIV infection saves $500,000 and there’s no doubt in my mind that the ATN is one of the reasons why rates of HIV infections in adolescents and young adults dropped. All of our studies look at cost effectiveness. We are very aware of spending taxpayer money well and efficiently.
I read another article elsewhere about the termination statement. The statement said, We are dedicated to restoring our agencies to their tradition of upholding gold standard evidence-based science as we begin to make America healthy again. I say to them, how can you make America healthy again if you leave youth behind? If you destroy the ATN? That's what you’re doing. There’s not a young person in the U.S. today who hasn’t been impacted in some way by HIV, STIs, mental health challenges, anxiety, depression, substance use, intimate partner violence—all of these things are part of what put young people at risk for acquiring or transmitting HIV.
Some of these letters that researchers have gotten have said there’s no appeal now, did yours say that?
Dr. Hightow-Weidman: Ours said that we could appeal. Ours said, no corrective actions were possible to suspend rather than terminate the grant, but that we could appeal.
Dr. Hosek: But it does say that this an appeal process, and so we are following that process.
Is there a timeline?
Dr. Hightow-Weidman: Thirty days.
Dr. Hosek: But we’re going to get it done much sooner than that.
Dr. Hightow-Weidman: We aim to get it done by the end of this week.
What does what’s happened say to young researchers in your field?
Dr. Hosek: Talk about devastation. Every cycle of the ATN has a scholars program. We are passionate about bringing in young investigators. You can see in [social media], post after post, people saying, This was my first study. This was my first experience in research. This is how I learned what I wanted to do.
It's unbelievable, and I don’t know what I would do if I was coming up in this field [as a young researcher]. It's too hard to even predict what direction this will go. It’s chilling. It’s chilling what's going to happen to science, and I fear what the health situation will become in this country based on this.
Have you spoken yet with any of the participants in the studies? Have you broken the news to them and what's been their reaction?
Dr. Hosek: We have not yet, because we, until this afternoon, didn’t have any guidance on how to close out these studies. We got the letter, but the letter didn't say anything about what are we supposed to do—we know ethically, legally, morally. We have an obligation to these participants, but there was no direction on how to do this the right way, and so we have not said anything because we couldn’t—we didn’t know what to say. Today, we just got the updated notice with closeout guidance. I think there’s still significant questions about what to tell participants, how to engage with them, how to link them to services that they need, how to pay for anything that they need. We’re still trying to figure that out. I imagine the news is getting out, so we will have to do it quickly. But we really needed guidance. We didn't know what to say.
Dr. Hightow-Weidman: But it was interesting in the guidance that they said is that you should let participants know how valuable their data is to research and science.
Dr. Hosek: But they just told us that we don’t do science.
Dr. Hightow-Weidman: And they told us that we don’t do good research or good science. So again, it’s just hard to make sense.
It’s all talking points, isn’t it?
Dr. Hightow-Weidman: It does feel that way. We’re going to lose the trust of communities. The communities who know the ATN, they value the ATN. Participants know that if they go to an ATN site, they’re going to be treated with respect and as human beings and not be judged for anything that they say or do. We're going to lose all of that and and we won't be able to get that back. And that hurts, not just HIV science, that will hurt any study in the future.