CAPT MARY GLENSHAW: Welcome to the NIH World AIDS
Day 2024 Event: Progress, Innovation, and Impact
in HIV Research. My name is Mary Glenshaw, the
Acting Deputy Director in the NIH Office of AIDS
Research, or OAR, and the emcee for today’s event.
On behalf of OAR and the broader NIH community,
thank you for joining us today. We greatly
appreciate our speakers for sharing your time
and insights as we continue a busy week here in
the nation’s capital to commemorate the 2024 World
AIDS Day observance. Let’s get started with some
logistics. This session is open to the general
public and being recorded for on-demand viewing.
The panel discussion will be followed by a live
question and answer, or Q&A session. We invite
all audience members to submit questions using
the Q&A feature in Zoom. The Q&A icon appears in
the toolbar directly beneath your video display.
Click on it to submit your question for the
panel. You can see on the slide exactly how
this should appear. So, let’s get started. We
are so grateful to bring together an esteemed
group of speakers for today…today’s discussion on
progress, innovation, and impact in HIV research.
The panel will be moderated by Mr. Francisco
Ruiz, the Director of White House…the White
House Office of National AIDS Policy, and Dr.
Geri Donenberg, the Associate Director for
AIDS Research and Director of OAR at the National
Institutes of Health. It is my pleasure to first
introduce Dr. Donenberg. Dr. Donenberg joined NIH
in October this year, bringing more than 25 years
of domestic and international research experience
across the HIV continuum, with an emphasis on
health equity and global impact. Working in close
collaboration with NIH institutes and centers, she
now leads OAR in coordinating the NIH HIV program
to achieve pandemic control through the prevention
and…of transmission and improvement of health.
Dr. Donenberg, welcome. The floor is yours.
DR. GERI DONENBERG: Thank you. I am very excited
to be here, and I am thrilled to be part of
the effort right now at the NIH to make HIV a
non-health threat worldwide. As was mentioned,
I have spent 25 years in academia at the
University of Illinois, Chicago, running
many studies funded by the National Institutes
of Health to involve…involving young people whose
behavior and psychological distress put them at
risk for acquiring HIV, as well as studies that
improve mental health and/or adherence among
youth with HIV. And, to my great fortune,
with terrific colleagues, I’ve been able to lead a
number of studies in sub-Saharan Africa to prevent
HIV and improve quality of life. I was trained
as a clinical psychologist, so you’ll see that
most of my work has this as mental health as an
underlying theme. But most recently I was…I added
implementation science to my behavioral and social
science expertise. And I’ve also had a lifelong
commitment to an action toward mentoring early
stage investigators. So, at this point in the
epidemic, I couldn’t be more excited to be joining
this effort to go the last mile. We have so many
tools now in the HIV prevention and treatment
toolbox, and we just need to get them to the
people who need them the most. And that involves
ensuring equal access to these innovations,
and implementation science is precisely the type
of research we need to ensure equity in reach,
adoption, uptake, and sustainability. So, like my
colleague said, I want to sincerely thank you for
joining us on this important day and my fellow
speakers, NIH partners, as well as the O…OAR
staff who are helping to celebrate everything
we have accomplished. For those of you who
might be a little less familiar with the Office
of AIDS Research at NIH, we were created in 1988
by a congress…congressional mandate
to oversee, coordinate, and manage
the NIH…HIV research portfolio. So, our role
is to really convene, catalyze, coordinate,
and communicate HIV-related research with our
diverse partners across the research ecosystem,
and that would include the rest of NIH, HHS,
other government agencies, academia, community,
and nongovernmental organizations. And of course,
we strive to make sure that the research funding
is directed at the highest-priority areas and
addresses the most current and emerging gaps. So,
as we take…help and lead this office, we also
help coordinate the annual NIH World AIDS Day
observance, including this event. And World AIDS
Day was established to unite all of us in our
efforts to end…to end the pandemic, to make HIV
a non-health threat, to support people with HIV,
and to honor and remember those who we’ve lost to
AIDS. We have made stunning successes in this…in
this struggle. We have transformational research
that has turned HIV and AIDS from a certain
death sentence into a chronic illness, and we are
extremely proud. And then recent discoveries are
changing how we actually address HIV prevention
and treatment, including a new medication that
prevents HIV transmission and the development
of novel strategies to encourage HIV testing
and treatment. So, thanks to these innovations
and those in service delivery, we are trying
to identify creative ways to ensure equitable
access to these interventions, particularly
those who are disproportionately impacted by
HIV. And yet, we know that many…structural and
social factors continue to impede access, reach,
and adoption of these effective prevention and
treatment strategies. So, this year’s event
call…we’ve titled Progress, Innovation, and
Impact in HIV Research. And it’s to celebrate the
breakthroughs that we’ve seen while simultaneously
calling attention to the considerable work that
remains to ensure that all of the progress we have
achieved reaches the communities and the people
most in need across the U.S. and around the world.
Today’s event will highlight recent progress,
including the development of novel strategies
to encourage prevention, testing, and treatment.
It will articulate the importance of sustained
investment in HIV research that is in direct
response to the needs of communities. And, today
we’ll emphasize proven and potential opportunities
to get interventions to those who need them to
improve health and achieve health equity. So, I
thank you again for being here, and I’m going to
turn the event over to Captain Mary Glenshaw
to introduce my co-moderator, Francisco Ruiz.
CAPT MARY GLENSHAW: Thank you, Geri. I’ll now
introduce, as Geri said, our co-moderator for
today’s discussion. We are delighted to be joined
by Mr. Francisco Ruiz, the director of the White
House Office of National AIDS Policy. Mr. Ruiz
is a true groundbreaker. As the first openly
HIV-positive Latine in this role, he has brought
a fresh perspective to lead the federal HIV
response. During his tenure, he has intentionally
centered populations most impacted by HIV,
including Black, brown, and queer communities.
As we commemorate World AIDS Day this week,
the AIDS quilt is displayed for the first
time on the south lawn of the White House,
and the administration will soon release the
first national HIV/AIDS strategy progress
report. Francisco, thank you for your leadership,
and thank you for being with us today. Welcome.
MR. FRANCISCO RUIZ: Good morning, buenos días.
Thank you, Captain Glenshaw, for the invitation
to join you and our esteemed panelists today for
this timely NIH webinar. As we gather here today,
we’re reminded of the essential role that research
plays within the broader federal response to HIV.
This webinar serves an opportunity not only to
reflect on the achievements, but also to chart
the course forward as we update the national HIV
strategy. Our discussions today are framed by the
remarkable progress we’ve seen across the United
States, fueled by the relentless innovation and
impactful research. Since the inception of
the national HIV strategy, we have witnessed
significant strides in reducing HIV incidence,
improving treatment outcomes, and expanding access
to prevention tools like PrEP. For instance,
HIV incidence among Americans aged 13 and
older decreased by 12 percent from 2018 to 2022.
Notably, incidence among young people aged 13 to
24 saw a dramatic 30 percent decrease. While we
celebrate these milestones, we are also reminded
of the disparities that persist, particularly
among Black and Hispanic, signaling there are
efforts that we must continue to intensify to make
sure that everyone has access to these resources
and this in…innovation. The role of research in
our national HIV strategy is paramount. It is
not just about creating knowledge but ensuring
that this knowledge translates into practice.
Implementation science plays a critical role
here, bridging gap between research outcomes and
community needs. It ensures that our scientific
advancements support and do not [inaudible] the
lived experiences of those affected by HIV. As we
proceed today on today’s webinar, let’s keep in
mind that each statistic we discuss represents
individual lives—lives that are being improved
through research, policy, and collective action.
Together with our contributions, we continue to
advance the goals of the national HIV strategy,
ensuring our scientific endeavors translate
into tangible benefits for all affected by HIV.
So, thank you for your dedication and for your
participation today. Let’s continue to push the
boundaries of what is possible in HIV research,
implementation, and policy. So, with that, I…I
pass it back. I believe I am now introducing the
panelists. I…you know, we’re really excited to
have our four…four panelists today, Dr. Latesha
Elopre, who is the Associate Professor Division
of Infectious Disease at The University of Alabama
in Birmingham. We have Dr. Eric Freed, Senior
Investigator of HIV Dynamics Replication Programs
at the National Cancer Institute at NIH; Dr.
Jeanne Marrazzo, Director of National Institutes
of Allergy and Infectious Diseases, as in…at
NIH; and Dr. LaRon Nelson, Independent Foundation
Professor of Nursing, Yale School of Nursing.
And with that, I pass it back to Dr. Donenberg.
DR. GERI DONENBERG: Wonderful. So, for
our first topic, we want to celebrate our
advances and decades of…of investment that have
led to incredible progress. In my own research,
I’ve been pleased to be able to see the power of
mother-daughter relationships and communication
that prevented sexually transmitted infections
in young women 1 year after a social behavioral
intervention. And even more than the data, we
see that mothers and daughters have shared with
us how important it was to learn to communicate
with one another and how that’s transformed their
relationship and their ability…feeling equipped
to talk about PrEP and how to use condoms. So,
I’d like to start with you, Dr. Marrazzo.
Over the past 40 years, as you know, we’ve
seen incredible…incredible progress. What would
you say are some of the recent advances in HIV,
and how might implementation science help
to ensure that they are…are available and
reach the people who most need them? You are on mute.
Apologies.
DR. JEANNE MARRAZZO: No, my apologies.
Can you hear me okay now? Sorry.
DR. GERI DONENBERG: Perfect.
DR. JEANNE MARRAZZO: So, thank you for the
question. Thank you for the opportunity to
participate. And a warm welcome to you in your
new leadership role. It’s great to have you here,
and I really look forward to working with you to
address some of the things you brought up in your
opening remarks. You know, it’s…it’s a little bit
tough to choose what is most exciting about recent
discoveries because we have had a pretty bountiful
last year, let alone last few years. But I’ll try
to kind of highlight some of my favorites from
the past year. And I do think it’s important to
your point that not only have we made advances in
the biomedical sciences, but we have learned more
about how to safely and effectively get these
products to people where they live and where
they really need these interventions. So, let
me just go through a few of the interventions
that I think are really exciting. First of all,
there was a landmark clinical study most of you
may be familiar with, reporting that multiple
children who acquired HIV before birth and
started antiretroviral therapy in the first few
days of life remained free of detectable HIV for
more than 1 year after their treatment was paused.
And this is really terrific because it provides
a concept for further study with more advanced
therapeutics and can also give us some answers
about how we might be able to communicate and
prevent [inaudible] of long-term HIV infection
in the body. That’s a big one. The other one that
has gotten a lot of press just in the last couple
of weeks is a multicenter observational study that
found that kidney transplantation from deceased
donors with HIV to recipients with HIV was safe
and comparable to kidney transplantation from
donors without HIV. This is really critical.
Organs are in very short supply. And this,
I think you know, has directly informed some
recent guidelines coming out of HHS. So,
really, really important work. The findings, in
fact, were pivotal in enabling the Department of
Health and Human Services rule change to expand
access to kidney and liver transplants for people
living with HIV by removing the requirements
that had previously made it very challenging
to get transplants to those folks. Another area
my own interest in…in…in the past in particular,
is the evidence based on pre-exposure prophylaxis,
or PrEP. So, we have advanced our work on PrEP
in the context of reproductive health in several
ways, against getting to this concept of getting
people what they need, where they need it, when
they want it, right? Reproductive health being,
of course, a huge focus for many women who
remain at high risk for HIV. Several studies have
reported additional data reinforcing the safety
of the oral…of oral vaginal ring and long-acting
injectable PrEP formulations in pregnancy. And, in
fact, we recently shared a new analysis from one
of the efficacy studies of long-acting injectable
cabotegravir PrEP that found that CAB-LA did not
interact with long-acting reversible contraceptive
drugs. So really good news for people who want to
address unintended pregnancy, as well as
HIV. I think that Dr. Freed will discuss
this in more detail, but I’d be remiss if I
didn’t mention the ground-breaking findings
on injectable lenacapavir, which was found to
be safe and effective as twice yearly PrEP in
two large international trials just this past
week, published in New England Journal by Colleen
Kelley, and colleagues looking at this in men
who have sex with men and transgender women, and
previously in cisgender women. So, really amazing.
And I would remind you that this was a tremendous
achievement for the HIV response, but it was
also possible because of foundational scientific
discoveries from NIH-supported investigators
in partnership with industry scientists,
so getting back to some of Francisco’s comments
about how important it is to continue to recognize
the role of basic science in research and also
working closely with our industry partners. So,
there…these are all really big advances, but
more than 40 years into the pandemic, as you have
pointed out, we know how important and challenging
it is to translate these scientific advances to
equitable implementation and access at scale.
So, I want to remind people that NIH’s mission
is—in supporting HIV science—as you have said, is
to improve the health-related quality of people’s
lives, whether their goals are…are to achieve and
maintain viral suppression and prevent HIV-related
complications, learn their HIV status, or use an
HIV-prevention method tailored to their needs. So,
I think these options need to be safe, they
need to be effective, they need to be discreet,
and they need to be accessible. So, to that end,
we’re currently supporting implementation science
through Ending the HIV Epidemic in the United
States Initiative, in collaboration with our
federal partners. We’ve supported these projects
with the National Institute of Mental Health, in
particular, to answer some of the implementation
science questions in order to increase uptake of
these tools. We’re also in the middle of a
consultative process to set a vision for the
future of NIAID’s HIV clinical trials networks,
including the role that NIH-funded implementation
science is going to need to play as we understand
how to reduce some of these persistent barriers.
And just a reminder, we’re still inviting comments
on that plan for future funding. More information
is available at our NIAID HIV enterprise webpage.
And then the last thing I’ll just mention is that
in addition to applying classic implementation
science, we need to ensure we begin product
research and development with the end user in
mind. By that I mean that we need to plan for
impact by mapping clear pathways to rapid
regulatory decisions, scalable production,
and fair pricing before the start of any efficacy
study. So, I’ll pause there and look forward to
the reflections of my fellow panelists, and
thanks a lot for giving me the opportunity.
DR. GERI DONENBERG: Thank you, Dr. Marrazzo,
very enlightening. I would like to
invite the other speakers if you
have other comments of new innovations
or recent advances you’d like to share.
DR. LARON NELSON: Thank you, Dr. Marrazzo, for
those comments. And thank you also, Geri. I…I
guess I would say I’ve also been struck by the,
the pace of advancements and the discovery side,
particularly, you know, if we think about PrEP
moving so quickly from the first oral daily
option to now the potential of a licensed twice a
year [laughs] injectable is…is extraordinary. But
I think for me, the…the most exciting thing about
the progress is this…this willingness now to,
I think, address the complex drivers of the
epidemic in ways that just seemed impossible
that…that we wouldn’t consider. You know, when,
when I was starting out, the focus was only on
behavioral interventions and vaccines, you know.
But that was it. Because it was…we had to focus
on what we…what we said was modifiable. What are
the things that you could change? And you couldn’t
focus on structural factors because you couldn’t
change them. Those weren’t modifiable. But those
were the things that we have to change. [laughs]
And so, you know, for the…the…there wasn’t an
appreciation that system-level barriers and
inefficiencies were, I think, in the legitimate
scope of scientific endeavor, especially in
infectious diseases. And now that seems to
be changing. [laughs] And that’s exciting for me
because for the last, you know, the better part of
20 years, I’ve just been mad all the time [laughs]
because we haven’t been doing this. And I…I agree
with you, Dr. Donenberg, it does feel like this
is…we’ve reached that last mile…last mile to go.
And I think now more than ever, it seems that…that
this is a shot. We got a shot to really do this.
So, I’m excited about the progress that we’ve
made and…and things that are looking forward.
DR. GERI DONENBERG: Thank you, Dr. Nelson.
Anyone else like to share? All right, well,
maybe it sounds like we have a number of
innovations that we have to be proud of,
and we’re finally getting to some of
the more…oh, was there someone else? Oh,
sorry. And that we’re finally getting to some
of the more underlying, maybe difficult and
complex factors that are driving transmission,
driving prevention and treatment, and that
we’re moving in the right direction to get
to that last mile. So, I’m going to pivot,
and I’m going to hand over to Dr. Francisco Ruiz,
who will lead us in a discussion on innovation.
MR. FRANCISCO RUIZ: Awesome. Great. Thank you. Now
let’s focus on the critical role of innovation and
really sort of talk about the whole of government,
whole of society approach…to combating HIV. We
know the whole of society really includes…sort
of underscores the importance of collaboration
and coordination across various folks—and so,
that’s government, that’s health care providers,
community-based organizations, people with HIV,
and researchers—to make sure that we achieve
equitable health outcomes. And so, the first
question that I have here in this regard is,
what is the role of innovation in sustaining
and accelerating—again, going with our theme
for World Day’s Day—sustaining and accelerating
research progress to reach communities most in
need? What have…where have we seen innovative
approaches helping achieve tangible gains for
our communities? And so, I invite maybe Dr.…Dr.
Eric Freed, if you want to start the conversation.
DR. ERIC FREED: Yes. certainly. Thank you Dr.
Donenberg for putting in OAR for putting this
together, inviting me to participate. So, I think
it’s very important to keep in mind that although
we have made tremendous progress in the last
40 years in developing drugs that combat HIV
infection, we still have no vaccine and no cure.
So, we are really…you know, our…our ability to
treat HIV infection is based on the really highly
efficacious drugs that have been developed.
However, I think I really want to stress that we
need to continue innovation and basic research to
develop new drugs because resistance to the
current drugs are…is increasing in…in many
parts of the world. So, Dr. Marrazzo alluded
to lenacapavir, which is really a…an exciting
innovation that’s come out of partnerships
between basic research and…and industry work
at the NIH extramural community and…and companies.
And just to…to contextualize this, we have learned
a tremendous amount about a part of the virus
particle known as the capsid. So this is a…a
proteinase shell that surrounds the viral core
in the virus particle. And a signature feature
of lentiviruses like HIV-1 is their ability to
infect nondividing cells—and this has been known
for decades—so we know that the incoming viral
complex has to cross an intact nuclear envelope
in order to productively infect the cell. And
we’ve also known, again, that this capsid protein,
or CA protein, forms the outer shell of the
viral core, but really, only recently has it
become clear how important the capsid is in early
events in the virus replication cycle. The capsid
interacts with host factors both during nuclear
import and also as it crosses the nuclear envelope
and into the nucleus. This is work from…from a
number of labs. So, this work, this basic science,
has really revealed that the capsid is a key
fundamental part of the virus replication cycle
and is therefore a viable target for developing
antiretrovirals. There was a prototypical capsid
inhibitor known as PF74 developed by Pfizer that
was really helpful in uncovering many of the key
aspects that I just alluded to. But more recently,
work from Gilead led to the discovery—along with
academic partners—led to the discovery of
GS-6207, or lenacapavir, which has really
shown remarkable efficacy not only in treatment,
but I think even more importantly as PrEP. And
two papers published in [inaudible] Medicine
showed really stunning success in…in PrEP. And
the…the …the chemical properties of lenacapavir
allow it to be administered as a twice-yearly
injection. So, this really removes many of
the barriers to former or current…currently
used PrEP modalities in which oral pills need to
be taken in…in many cases daily. So, I…I think
this all really stresses the need for continued
basic research to uncover fundamental aspects of
the replication cycle that can then lead to
novel targets for antiretroviral therapies.
MR. FRANCISCO RUIZ: Thank you for that. Anyone else from the
panel want to sort of speak to that? Welcome.
DR. LATESHA ELOPRE: Thank you so much
for having me. And I just want to add,
I think it’s a…amazing time right now with regards
to all of the innovations that have been recently
published for long-acting modalities in regards
to people who are living with HIV, but also people
who potentially could be diagnosed with HIV in
the future. I think it opens a lot of doorways,
but speaking and tapping into what Dr. Nelson said
earlier in regards to having these human-centered
approaches that are really challenging and
pushing against the structural barriers and
the interpersonal and policy-level barriers that
people face when they’re trying to access these
innovations, I think also is something that has
been really groundbreaking in regards to science
in this point in time. Implementation science
has moved. I think this idea that you have these
sometimes 100 percent effective interventions that
aren’t really reaching and having that efficacy in
all populations and trying to uncover why. So,
I’ve been excited about that in my own state,
which is a non-Medicaid expansion state.
I’ve also been really excited around the
idea in resource-limited settings. How can you
capitalize on precision public health and large
data sets to make sure that you’re really pushing
resources to where they’re needed the most?
Targeting communities that are recently having
outbreaks or having uncontrolled viral loads and
trying to, again, using those human-centered
approaches, address why that’s occurring. So,
I think marrying the two is probably the
way forward to getting to that last mile.
MR. FRANCISCO RUIZ: Dr. Nelson, anything
you want to add to that now that you spoke?
DR. LARON NELSON: Yeah, I think for me, I was…I
was struck with Dr. Freed mentioned at the top
of his comment about vaccines. I…I think that, you
know, we do…we do well to celebrate all the events
that we’ve had, but we do…we don’t have a vaccine.
And so, I don’t think we have everything we need.
[laughs] There could be more. And I…I really
think that vaccines have gotten sort of wrapped
up in controversy for other things, which…which
could have an impact on how we continue to try
to accelerate advances in HIV vaccine production.
But I think that’s…that is important. And I think
a lot of what I’ve learned, how I’ve learned
how to innovate in…in the field where I work
in specifically, has been from learning from
and in some ways being mentored by people
who’ve really been leading the charge on trying to
find the vaccine. And I think staying determined,
learning from failures, and finding ways to
continue to innovate is something that we…we
still have to do in hopes that we will
get one one day. And even if we don’t,
we’re…we’re blessed that we have so many other ops
that can help us make progress in the meantime.
MR. FRANCISCO RUIZ: Thank you. I think
that’s super helpful. I think the…the
main takeaways that I got from this is,
sort of, we’ve made progress, so, yes,
check. But there’s still more work to be done,
right? I think there’s some conversations. We
talked about the basic science piece. You know,
we don’t have the cure, we don’t have the vaccine,
and that’s something that we still need to sort
of think through. And we must capitalize on the
progress, right? We talked about intentional
human-centered approaches, making sure that
we’re sort of making sure everyone access…has
access…to the science and…and innovations that
we’re developing. And the last piece that I
heard is really making sure that we disentangle
the important work that we’re doing as public
health and…and researchers from the politics,
and making sure that we address some of
the barriers that we may see in various
jurisdictions and making sure that folks are sort
of being able to appreciate the science as science
and disentangling it from some of the politics
that we may have be seeing as of recent. So,
thank you for the discussion. I’m going to
pass it back over to Dr. Donenberg. Thank you.
DR. GERI DONENBERG: Thank you. So, this is, sort
of, the final part for our panel discussion. And
the question that we would like to discuss
is, sort of, the future of HIV research and
the additional work that needs to be done.
So, we’ve been talking about that quite a
bit. We’ve been reflecting as a panel on the
advances and in some of the ways that the…maybe
some of the barriers—particularly maybe some
of the individual, interpersonal,
organizational,
and structural factors—that are going to impact
or that do impact, whether we have these effective
strategies are ultimately going to reach the
populations most in need, the context most in
need, low, sort of, more resource-constrained
settings and so forth. And so, we want to make
sure in that way that our interventions that are
effective are feasible, acceptable, appropriate
for the context, for the culture. Otherwise,
we know they won’t really be sustained over
time. And so, this is where I think all of us are
recognizing that implementation science can really
take us to that final…that mile. So, the question
for the panel is, what could future investments
support across the entire research continuum—so
basic science, clinical interventions, behavioral,
social science, even implementation
science—that can drive greater impact,
increase health equity, and achieve epidemic
control? And maybe we start with Dr. Elopre?
DR. LATESHA ELOPRE: Thank you. I
think that’s a wonderful question,
and I think that is maybe the entire point of
the panel. Honestly, I think a lot of this needs
to move towards addressing syndemics that are
affecting populations in greatest need. I agree,
again, with Dr. Nelson when he said that there
was a lot of frustration when you first started
and you were taking care of patients, or
you’re taking care of clients, and you felt
like you were solely focused on one aspect of
their health and not their whole being. What,
as a person in a rural state that doesn’t have
access to food, to housing, to clean water…where
does HIV fit in that picture? And I think that in
order for us to really see gains in the epidemic,
we’re going to have to, I think, disentangle some
of that and try to understand from a whole person
standpoint, how can we improve the overall health
and wellbeing of the people who are being impacted
the most. So, I…I do think using implementation
science, using precision public health,
I think all will help with all of that.
But honestly, focusing on syndemics that
are affecting populations in greatest need
will probably move the needle the greatest.
DR. GERI DONENBERG: Thank you. Anyone
else? Yeah, go ahead, Dr. Nelson.
DR. LARON NELSON: Yeah, I’ll add to that.
Thank you for that question. I appreciate Dr.
Elopre’s…those comments. You know, I think, to add
to that, the biggest challenge from what I’ve seen
in achieving these implementation of innovations
just is really finding out a way to make the
economics work. I mean, when…even places that
we’ve gone through, I’m leading a study with Chris
Beyrer called HPTN 096 in…in four communities in
the South. And every place that we’ve gone to,
we…we talk to them about oral PrEP, are they
prescribing it? And the current injectable,
thinking about what if a twice-yearly injectable
comes through? And they all are worried about
how are we’re going to pay for this? How are we
going to make this work [laughs] in our practice,
right? It’s…it is about implementation science,
but they’re not questioning whether or not it
works [laughs] or whether or not it’ll
benefit. They’re questioning how are they
going to implement this evidence into their
practice in a way that they can afford. Many
of these practices are business owners. I mean,
it…you might not think about a physician as a
business owner, [laughs] but if they’re running
their private practice, they are thinking about
it as if they’re running a business and they
got to pay the admin staff and the nurses,
and they got to have all these things. And
they have to make decisions about what can
they implement that allows them to give the kind
of care they want to provide and still be able to
pay their bills. Maybe I’m oversimplifying it,
but…but I think thinking about how to make the
economics work is going to be key, which I also
think means working with partners differently.
Like the…that the…I don’t know what…what I would
say it. The pharmaceutical companies—we can’t just
sort of look at them as the suppliers [laughs]
right? They have to be partners. Dr. Marrazzo
talked about thinking about pricing strategies
now while you’re doing the efficacy trials. Like,
“Yes, the time to think about it is now.” And
that might seem odd, but that’s what we have
to do if we’re going to get to a point where
this…this product is licensed and whether it’s
going to actually do anything. Because if nobody
can afford to use it…and I’m not talking about the
end users affording to use it. I’m talking about
can practitioners [laughs] afford to incorporate
this into their work? It’s going to make a big
difference or…or not. I think insurance companies,
we have to think about them as more than payers,
although that’s their primary function. But are
there ways to incorporate them into our research?
Can they, can they experiment with different
policy pricing strategies or reimbursement
strategies that optimize access to the different
types of medications, whether treatment or PrEP?
Do the reimbursement schemes encourage physicians
and nurse practitioners to prescribe and to follow
up and [laughs] to make sure they retain them?
If it…if it doesn’t…if there’s not a financial
incentive…let me say I’m a nurse practitioner,
okay? But if there’s not a financial incentive
to do a bunch of things—we already got a bunch of
things to do—it ain’t going to get done. [laughs]
That’s just kind of how the economics of it works.
But I…but I think we don’t have to leave that to
chance. I think if we know that these systems work
that way and we…[laughs] we know that people’s
behaviors sort of inclined to be that way,
we can create incentives with economic ones,
financial ones to make this work to…to make
the research make a difference. And…and again,
I think that’s the point of some of this panel,
is to talk about implementation science is that
we need to make the research have an impact. And
I think there are other ways that I haven’t
seen, that we’ve tinkered with quite yet. And
I’m…I’m curious about those things. But I think
the economics and the financial sort of levers
are ways we can really think about, can we push
this further down the line towards that last mile?
DR. GERI DONENBERG: Thank you. I
actually really…that resonates,
I think, a lot with folks probably listening
in, as well as me. And I think that’s…exactly
where implementation science research belongs:
understanding the system-level factors that are
going to impact uptake or adoption of these
strategies, right? The strategy would be,
let’s say, injectable PrEP. Well, what
are the factors that are going to impact
whether the system, or the physician, or the
nurse practitioner can pick it up? And you’re
naming economics, which of course is critical.
And I would add, not just do we need incentives,
we need to make sure there are no disincentives
also. And I think that’s a critical issue, because
if there are disincentives to do it, we’re…we’re
climbing an uphill battle that we’re going…we’re
never going to reach the top. So, I think that’s
really important. And I…I appreciate those
comments because I think when we talk about where
can the research go, right, where can the most
impactful research go, it’s to maybe step away
from the individual person and to start looking
at the broader systemic factors. And…and yes,
I think syndemics is critical, but you can also
start to think of…a little bit about, you know,
the health care system, the, you know, Medicare,
insurance, all these things that we know. And
how do we study those to understand and drive
impact in the next…next stage of this research?
Other folks who might want to weigh in on this?
DR. JEANNE MARRAZZO: Sure, I’ll…I’ll weigh in
because, of course, with NIAID, our job is to
look at the data and then think about what the
scientific priorities from our standpoint are
going to be. I…I…I…I hear what you’re saying, but
I think we can’t step away from in…the research
at the level of the individual, because at some
level, you know, we aren’t all the same. There are
systems, but there are some people who are going
to be different immunologically, virologically,
and behaviorally, and…and there’s so many
complexities there. So, I think it’s…it’s great
that we have a focus on the entire spectrum. And
that’s what’s the beauty of this panel, because
we really are…are thinking, I think from…from
…from the individual all the way up. You know,
I think if you look at the last UNAIDS report
it was very exciting, but it was also really
humbling. So, for the first time we saw in 2023
that more people were newly diagnosed with HIV
outside of sub-Saharan Africa than in sub-Saharan
Africa. And that means that in the Middle East,
in North Africa, Eastern Europe, Central
Asia, Latin America, we are not seeing the
kind of response that we need. Why? Because we’ve
invested really well in sub-Saharan Africa, right?
Between PEPFAR and a lot of the work that you’ve
mentioned, Geri, and many of us have done. So,
I think we need to think very carefully about how
we scale prevention efforts to everybody who needs
them, and to really point out what the benefit
is when we do that. So, continuing to review our
priorities, knowing what the emerging epidemiology
and the biology are is really, really critical.
The other thing I think about the UNAIDS report
and that I talk about a lot is that I really
think we need durable individual immunity, and the
only way we’re going to get that is by a vaccine.
Health care systems are often threatened, they’re
often fragmented. Health care workers sometimes
are threatened and under, you know, under duress,
whether it’s economic duress or…or other duress.
So, we need intact systems to deliver the kinds of
things that we’re talking about, like long-acting,
you know, chemoprophylaxis for example. It’s
not that a vaccine would be a panacea, but it
would at least get us more to the point where
you can actually give everybody the individual
protection that you need, and ideally, that would
be lifelong. That’s our goal. So, that’s really
been a pillar of our scientific mission, I think
as…as everybody knows. And some of the exciting
things in the past year that I didn’t really
talk about include some of the groundbreaking
technology that has allowed us to target the
germline cells in the bone marrow, in particular,
that are letting us teach the immune system how to
develop HIV-specific immunity that could actually
get us the kind of response that we so far have
not been able to get from any of the HIV vaccine
candidates. So, the whole field, I think, is
really getting very exciting. And my…I guess
a little bit of my fear is that with all the
excitement around long-acting, you know, PrEP,
which I am beyond excited about, that we can’t
forget that we…we just can’t take our foot off
the gas when it comes to understanding,
you know, how we can get to a vaccine,
especially with some of the pivotal findings in
the last year. Last thing I’ll say, too, is that,
you know, I mentioned some of the countries
outside sub-Saharan Africa that are being
effective. Again, having worked with Latesha in…in
Birmingham and recognizing the challenges in the
South, even the PrEP that we have, uptake
is incredibly uneven. Perceptions, stigma,
all of those things are really, really difficult
to overcome to get people to use what we have,
and maybe will be difficult to get people to use
what we employ. So, we don’t know that there’s
going to be a magic shot that’s going to work
for these populations. So, I do think that our
investments, you know, do need to help resolve
not just the biomedical, but also the structural
factors and some of the socio-behavioral factors
that you…that you mentioned. So, I’ll stop there.
DR. GERI DONENBERG: Thank you. Dr. Freed,
it looks like you went off mute to…
DR. ERIC FREED: Yeah, I…I…this is really…really
a…just a question for my colleagues who are
involved in implementation, particularly
in the South. What is the thinking about
the use of…of long-acting injectable PrEP
versus oral daily PrEP? Oral daily PrEP,
as Dr. Marrazzo just pointed out, is not being
used. The uptake’s, you know, 30 percent or so or
less. What is the thinking, sort of, on the ground
about the extent to which injectable PrEP’s going
to be game-changing, particularly, you know, twice
yearly or something infrequent along those lines?
DR. LATESHA ELOPRE:
So, I think it’s amazing that we’ve, again,
moved into this space where we can talk about
long-acting in really a meaningful way. And when
studies have been done that have really tapped
into the voices, I think, of southern communities
and of brown and Black communities, there has
been interest in long-acting. I think some of
the studies have varied on whether they want a
long-acting oral or a long-acting injectable, but
there’s interest. From a structural standpoint, a
system level standpoint, talking to clinics—which
I think is where this is all going, going out of
a specialized ID setting and going into primary
care providing provision, going into gynecologic
provision—there is resistance to implementation
of long-acting modalities. And I think it is
because of the structural barriers that we’ve
just identified and how you can meaningfully
get that type of modality into the hands of
your patients while not interrupting workflow,
not having to stress an already stressed,
under-resourced system that doesn’t have
the workforce to support it. So, I think that
is the major concern. And I…I do sometimes,
living in this setting, want to continue to
challenge that, and push that, and see how you can
leverage what you already have to move the needle
in that way. But it can be…it can be challenging.
DR. LARON NELSON: Let me…That’s a very serious
question you asked, Dr. Freed. I agree with Dr.
Elopre’s responses. I…I want to point to something
that Mr. Ruiz said earlier. He talked about what a
whole-government approach might look like. I think
people in general welcome the idea [laughs] of a
PrEP option that is has…has less frequent dosing,
but how they do it, without trading an awful lot,
is a different story, and it’s because of
some of these structural barriers. But I was
in a conversation recently with Dr.—Mr. Ruiz—will
notice with…on the NIH funded study, talking with
CDC about some structural issues we’re hearing
from providers who are thinking about injectable
cabotegravir, and how hard that is and why it’s
not happening, and then talking with Center for
Medicare & Medicaid Services. So…but it…it made
me realize, it takes…it does sort of take a
coordinated government alignment [laughs] to make
it happen. And I wasn’t having conversation about
something I came up with. This was something that
physicians, and nurses, and social workers would
just…we had meetings with them, they would say,
“Here’s the issue.” But somehow it wasn’t getting
to all the right people at the right time. So,
the issue was about how to support, you know,
in a researcher role—because people would
sometimes tell you stuff they wouldn’t tell
their project officer or whatever—but it was
like, do…is a responsibility we have if we can
understand where some of these barriers to…to get
it to the folks who would know what to do in their
own little realm, but how to get them to, sort of,
think about it together [laughs] so that this is,
sort of, a synchronized, coordinated response
that could address some of these issues? Because I
think if we make it easier to implement something
like twice annual injectable PrEP, people would
do it. [laughs] But it…it can’t be, to Dr.
Donenberg’s point, disincentives to doing it.
We have to minimize the number of disincentives.
And I think people are very keen on identifying
what’s going to…what the disincentives are. They
can see those very clearly, [laughs] even though
sometimes we don’t see them. But I think there
are solutions, and I think this…this…I’m saying,
“whole-government approach,” because I’m using
Mr. Ruiz’s comments, but I think the more and more
that we can align…align these sort of priorities
and these different organizations to all have
different responsibilities, but that don’t
always…they don’t always match up at the…the
right time. So, that’s my…my thought on that. Oh,
let me say one more thing that’s related to that,
which is, I…I think that, sort of, my lesson from
having done that work is listening to people who
are…who are saying stuff, and I could just take it
as somebody just letting off, or I say, “This is
real information. [laughs] This is really what’s
happening. What do we…what do we do with that?”
And it was difficult. I’m not a policy person,
not an economics person. I’m not an actuarial.
But I knew that folks were saying, “Here’s
what we want to do.” And I think typically,
not in all universities, but I guess on average,
we have our ideas, we have our interventions, and
we want to get them out there into the world. And
some folks call this sort of a “put the innovation
push” right? “I’m going to get this out to you,
and Birmingham, and Montgomery, and Dallas, and
I’m going to do it for you.” Which is different
from when communities are pulling. They’re saying,
“That’s nice, but here’s what we need.” [laughs]
Right? And we have to be willing to try to figure
out a way to do what they’re telling us they want
and how they want it. And that’s not always easy,
and that requires new thinkings and us to make
new…forge new partnerships. But I think that is
sort of one example. And I think for long act…for
these…these new long-acting options, it’ll really
be listening [laughs] to what they’re saying.
And it doesn’t even have to make sense to us,
but they’re telling us [laughs] “Here is how it
has to work if you want to do it.” And finding
ways to do it. And again, I…I think there’s more
of an appetite in the scientific community. It
seems that NIH is more willing to consider
supporting studies like that, that might seem
unconventional because this is what community
is demanding. And they know. They know if you
do what…what you’re proposing that you want to do,
it’s not going to change [laughs] how I practice.
You know? And…and we’re good at measuring.
So I…I agree, we got to figure out a way to
measure…make sure what we’re testing works. But
we know how to do that, I think. But if we move
away from strictly, sort of, a push innovation
to, sort of, pull—let communities pull from
us what they need—I think we can be ready for,
you know, that product when it comes to market.
DR. LATESHA ELOPRE: Can I just add one last thing? I’m so
sorry.
DR. GERI DONENBERG: Of course.
DR. LATESHA ELOPRE: But I just wanted to say, as
really important aspect of this that I…I want to
stress, even if we have perfect systems—and there
have been studies like this where things are
completely free—we go out into communities, there
are people who aren’t going to approach the van,
who aren’t going to use the modality that we’re
talking about because of stigma and because of
the lived experience they carry that prevents
them from being able to move forward in that way.
I…I think that we have to understand on a deeper
level this implementation- and implementer-level
barrier that we’re experiencing with these
types of modalities, but we can’t forget the
people that we’re trying to reach and why we
haven’t ended the epidemic up to this point.
DR. JEANNE MARRAZZO: If…if I could just add to
that, it’s one of the reasons I think tele-PrEP
delivery, which takes away that interface of
somebody having to go to a clinic and…and,
sort of, interact with someone and admit to
a human that they actually need this and they
are “at increased” likelihood of getting infection
is really important. I wanted to speak to LaRon’s
point really quickly, because I think making sure
that research at every stage is representative of
the populations who need the results most,
is something we don’t talk about enough. And
that has to be, like, from collection of invasive
samples in early studies—if you want to call
it invasive, whatever, phase one—all the way
to recruiting for large efficacy trials. So,
one thing that our division of AIDS did last year
was they began requiring research teams to screen
every new study protocol, wherever it was in that
pipeline, to ensure that we are doing our best to
design representative processes and studies. So,
I…I think we don’t often think about that enough,
and by the time we get to the end point where
we’re talking about distributing something,
we think, “Oh, yeah, we should see if people
want to use this.” And that’s…that’s not the
way that this is going to work. And
that’s why it’s so great to have,
again, this spectrum of…of scientists
and community membership on the panel.
DR. GERI DONENBERG: Thank you. I would agree,
and I…I kind of want to highlight a point that
I think all of you have been making but haven’t
specifically said. But I think the ideas that
there needs to be choice of what kinds of
innovation someone will choose to adopt. You
asked…Dr. Freed, you asked about the uptake of
long-acting injectables. And even that I think
will vary around the world. This is World AIDS
Day, and I know we’ve made a lot of progress in
sub-Saharan Africa. But one…one issue that I think
is relevant here is within sub-Saharan Africa,
many of the adolescent girls and young women are
accustomed to…to taking injectable reproductive
health methods. So, injections for pregnancy
prevention and so forth. So, what we see,
have seen so far in…in…in…particularly in South
Africa in my experience, has been that those
young women are eager for long-acting injectables
because it…they’re accustomed to that approach
around reproductive health. That may not be
the case in other parts of the world. And so,
this issue of choice and continuing to build our
toolbox so that you can go out and say, “Here
are the variety of choices you have to prevent
HIV, prevent pregnancy, prevent…or receive your
treatment.” I think that’s going to be a key to
our success and understanding why some populations
prefer certain methods over others. So…and I’m
also hearing from all of you that we need to
really think about the whole person from the cell
to the quality of life, even for folks who are…who
have HIV. And I…and I want to emphasize that
because I think that it’s representative of our
panel, but it’s also representative of what we are
saying for…for all of us in this…in this event,
so. Anybody have anything else they
would like to add to the discussion?
DR. LARON NELSON: I want to ask Mr. Ruiz—because
he’s had such a…sort of bird’s-eye view,
if you will, across what we’ve been
doing in different sectors, research,
practice,—any ideas you have about
where we…you think we…should be going
in terms of the investment in prevention and
treatment domestically or internationally?
MR. FRANCISCO RUIZ: Yeah, thank you for that. I
think, you know, one of the…the conversations that
we’ve been having around the whole of government
or whole of society approach is making sure that
we don’t forget to center the people that we’re
serving. And I think oftentimes we get, sort
of…because we’re so busy doing the work and the
research, that we forget to center people. And so,
a lot of that’s a lot of the work that we’ve been
trying to make sure that was being…develop new
policies that they’re informed by the lived
experiences of people. I think, you know,
the National HIV Strategy that was released in
Biden’s first year also talks about racism and
how racism is a public threat, right? And I think
we need to…we can’t separate the HIV research
and the implementation of the research without
understanding the context within where that this,
this work is happening, right? We’re seeing more
and more as of recent anti-LGBTQ legislation
happening around at the state and local level.
So, we can’t forget about that, right? We’re
seeing the xenophobia happening around this
country, particularly in the South and also where
we’re receiving new arrivals. And so, I think
when we talk about HIV programs and research,
we also have to make sure that we, sort of, think
about how is this is being received for folks
who are oftentimes in media, either in social
media or in the news, that they’re less than,
that they’re not worthy of. And so, I think our
policy needs to reflect not only that, but also
the work, the science, right? And so having folks
who represent community at the table is paramount,
right? Making sure that folks get the message, but
also see the messenger as themselves as a member
of the community, I think is really important.
I think we’ve made some inroads in that regard.
And so, I think the…the other thing that is…that
was mentioned in all that…that I’ve been saying,
but also in what was mentioned earlier, is
really tackling stigma, discrimination and
the socioeconomic factors, right? We…we could have
all the great tools in our…in our…at a disposal,
but when we have these issues…and we’re
seeing stigma, discrimination even
from…from the onset of…of just testing, right? I
think Dr. Elopre…Elopre said…mentioned, you know,
so you see a van…it’s great that we have these
vans, but when folks have this hesitation because
of stigma, because who’s going to see me walk
into that van? I think we need to, sort of,
really address that. So, I think public campaigns
that really, sort of, speak to community,
that are created by community is really,
really important, especially when folks,
again, are seeing themselves as in the media, in
the news, in legislation by people who have power,
right? It’s not, sort of, just random people
saying these things, it’s people who are making
policy-led decisions at the state and local
level. And so, I think that is something that,
you know, I’ve been keeping an eye on. You
know, there’s…there’s a case right now that’s
being discussed in the Supreme Court around access
and…to health care issues. And so, I think it’s,
we can’t, you know, as we…as we move forward
in our HIV research, as we move forward in the
implementation of these programs, we also need
to…how does this…how are we implementing within
the context of…of these lived experiences? So I’m
not sure if I answered your question directly,
Dr. Nelson, but that’s…those are the things
that I’m thinking about, is like, “Yes,
we have these tools. Yes, and? [laughs] Yes, we
have these tools and how do we make sure that they
reach the communities in a way that is effective
and sort of culturally relevant to the needs that
they have?” You know, obviously folks are dealing
with housing issues, right? Employment issues.
They’re not thinking about a PrEP pill. They’re
not thinking about going in to get an injection.
They’re thinking about how am I going to get food
on my table? How am I going to get a roof over
my head? And so you know, tomorrow, actually,
at the White House, we’re having a symposium,
that a few of you will be joining us, that is
focusing on quality of life, right? So, yes, we
need these medicines. What are these other things
like mental health, housing, employment? What are
these other things that we need to make sure that
we’re also having conversations about? So sorry,
the…the caffeine started kicking in. So, I
hope…I hope I answered your question, Dr. Nelson.
DR. LARON NELSON: Yeah. Thank you so much. If
I’ll just say one more thing then, which is,
you know, I’ve been thinking about…just even as
you were talking, this…something that I’ve heard
for a long time—I’ve even said it—about the need
for sustainable everything, funding for research,
long-term research implementation in communities,
having community-based organizational clinics,
being able to sustain these interventions for a
longer period of time. And I…I have more recently
sort of wondered—maybe more than wondered—sort of,
pursued thinking about what’s the role of private
industry other investment into communities.
Because I’m not convinced that the types of things
we say we want, that we’re going to get it from
government agencies. We can’t…I don’t think we can
rely on it. [laughs] And…and I think that some of
the things for years, some of the creativity that
comes from community are things that just
never make it through the bureaucracy, the
peer-reviewed or whatever you call it. Those ideas
never make it because they…they’ve not been tested
empirically for long enough or enough studies,
and so they come across as risky. And I think
private sector’s more…has a better appetite for
things that might seem too risky for governments
to take on. And I think businesses, companies
have a…this is going to sound odd. They know
how to make money. If there’s a dollar to
be found, they can find it. [laughs] And so
they…they …they are good at keeping things going
to the degree that there’s a payoff for them. In
business sometimes it’s, it’s, it’s financial,
but there are other, sort of, value and payoff
that I think we can have from having folks be
willing to take on communities’ risky, odd,
bizarre ideas that they know will work for them
but that need an investment that is really hard
to get from our current grant-making system that’s
super competitive, as it should be. But…so I’ve
been thinking about, about that, too. The role of
government, whole government, and then the limits
of that and where…where we can also find other
partners who can build on a lot of the events
that we have because of government investment
in research. So, yeah, thank you for…for your
response to that question. And thank you, Dr.
Donenberg, for allowing me [laughs] to pose it.
DR. GERI DONENBERG: Of course. It…It brings
up two issues for me that I’d like to,
to raise. And then I know we…we want to move on
to the question and answer. But one is we call
planning for sustainability. That means from the
beginning, you start to plan for sustainability.
And sometimes that means you’re…you find
industries or sometimes you actually engage,
let’s say, the Ministry of Health at the very
start of a project so that there’s engagement
and commitment and buy-in. And you, you…for
some of my studies in the past, we needed,
sort of, a Ministry of health letter that said,
“If this intervention turns out to be effective,
we will then work towards scaling it broadly
and we will contribute.” So, I think it’s a
little bit of what Dr. Marrazzo said, rather
than waiting till the end. But it’s actually,
you know, right when you’re starting the study,
you’re planning for sustainability. And a related
comment is the use of folks from those communities
to deliver these innovations—and we’ve sort of
danced around that a little, I think, in this
conversation., so I’m going to bring it to the
forefront—that we really have, I think, both
an obligation and a good research question,
which is, can we really facilitate uptake,
and reach, and sustainability by training,
let’s say, community health workers or whoever
it is to actually deliver these, these programs?
And we’ve done some of that in Africa, where
we’ve trained young adults with HIV to deliver
trauma-informed cognitive behavioral intervention
to their younger peers, who are also living with
HIV. And, you know, it’s obvious that we can train
folks to do this. They can do it with fidelity,
and then we can assess whether that works.
But then we’re building capacity within those
settings to continue to deliver these programs.
And we’re strengthening the actual setting and
environment to deliver effective programs, not
just going in with our research assistants,
doing it and…and leaving. So, I just wanted
to call those two pieces out. And I think at
this point I want to turn it back over to Mr.
Ruiz to lead our question and answer session.
MR. FRANCISCO RUIZ: Awesome. I stood up, put the
standing desk up because we got some questions
queued in. And so, thank you everyone who’s been
putting in chat…questions in the chat. And so,
we have several questions. Let everybody come
in. Welcome more. So, folks, as…as they come up,
please put them in there. And…and I’ll ask from
my esteemed panelists: try to keep it condensed
in terms of your response if you can. Maybe 60…60
sec…60, 90 seconds so they can get to you. We have
a…a bunch of quick but good questions here.
The first one I’m going to…is directed to
Dr. Marrazzo. Can you speak more to the goal of
ensuring fair pricing prior to launch of efficacy
trials? How will this be determined, and who will
decide fair pricing to U.S. residents or globally?
DR. JEANNE MARRAZZO: So, I can say it’s not us, right? So,
we at NIH have no sort of direct impact or control
in this area. I think where our responsibility
lies is when you think about designing,
particularly the later phase efficacy studies,
you got to think about that in terms of investing
in that, right? So, you’re not going to invest in,
generally…in a gigantic phase three efficacy
study if the intervention is going to cost,
you know, a million dollars because why would
you ever do that? So…so I think for us it’s more
about how we design the…the …the studies as…as
they move into later phase in particular. And
also having conversations with our partners
who can impact those things more profoundly.
MR. FRANCISCO RUIZ: Awesome. Anyone else want to
add to that? Alright. Give you guys a…alright.
Next question. So, this one is focusing on aging
population with HIV, which is a very important
topic that we’ve been talking more and more
about, thankfully. So, given that the population
of people in HIV in the U.S. is increasing over 60
years old, the time available to impact length and
quality of life in the aging population is growing
shorter. How are you planning to accelerate the
move from basic research to things that impact
our lives? As a member of this population,
basic research is great, but I have to ask,
so what? Anyone want to respond to that?
DR. LARON NELSON: I don’t have a response to the
“so what” part but just wanted to raise that,
you know, in my work in prevention primarily,
we are trying to take get more attention to
folks as they age both understanding
how their needs evolve as they age,
appreciating that they still have needs as
they age [laughs] for prevention, and then
finding smart, relevant ways to…to respond to
those and the types of interventions we develop
and…and studies we develop with communities. So,
I appreciate that, that comment. I…I think that
I…I can’t speak for basic research because
I’m not a basic scientist, but certainly in
the form of work that we do, we try to make sure
that folks are involved because what we develop,
we wanted…want to make sure that it’s relevant
to broadest across that kind of people.
DR. JEANNE MARRAZZO: And…and just real quick, if
I could jump in, Francisco. You know, I…I…I think
this is hugely important. We have been working
closely with not just National Institute of Aging,
but…but more obviously with a reprieve trial with
the National Institute of…of Cardiac and…and Heart
[laughs]…NI…National Institute of Heart, Lung,
and Blood. And so…so…and we remember we did the
reprieve study, which showed that in people who
were living with HIV, even when they did not
have high cholesterol, statins improved multiple
markers of metabolic health in clinical outcomes.
So, I think that we have to keep pushing
this. To me, we haven’t really talked about
the fourth 95 today, right? If you think about
the three 95 buckets, you know, the, sort of,
getting diagnosed, getting into care, getting
virally suppressed, to me the fourth—and what
we’ve been talking about—is quality of life of
people living with HIV. And that means aging care,
mental health, reproductive health, sexual health,
all the things that we have been talking about
that are the benefit of helping people live longer
with HIV. So, please don’t feel like when we say
we’re talking about basic science, that leaves
this group out. Because we need to understand
the basic science of aging and inflammation and
why people living with HIV have an inflammatory
profile that is very much more accelerated than
people living without HIV. So, lots of fantastic
basic science, as well as implementation
science, in this area. We got to get there.
DR. ERIC FREED: I might jump in and…and
address the “so what” part of the question,
which is basic science led directly
to the development of lenacapavir,
which is a game changer in PrEP and
also potentially in treatment. So,
I think it’s really important that we
continue our investment in basic research.
MR. FRANCISCO RUIZ: Awesome. Thank you so
much. All right, so the next…I have next set of
questions combined. If we take community-centered
approach of this…the …the dissemination of this
research and innovation must be in language
that the community can understand. So,
too often, good news is shared without the
community understanding it. So, Dr. Marrazzo,
I think you mentioned that people living with
HIV can be organ donors to others with HIV
in a nod to the secondary prevention,
but many people do not know that this
has existed over a decade. Can you send…can
you spend some time talking about the HOPE
Act to the audience to sort of explain
a little bit more what that entails?
DR. JEANNE MARRAZZO: So, the HOPE Act is…is
…is…comprises a number of…of key things.
The…the …the main thing, I think, just
given the little time that we have left,
is that it emphasizes that people living with HIV
can be both recipients and donors for…if organs
are healthy. And…and people can…can sustain that.
And you can, of course…the study that was done on
deceased organ donors, so obviously that’s
a source. But it really just emphasizes…I
think that it…it makes clear that HIV as an
infection, as a condition in somebody should not
be a barrier to appropriate management of the need
for an organ transplantation. And that’s really,
that’s like…that may sound like kind of
evident, but that’s come…that’s taken a
long time. You know, there have been people
who’ve been doing it, but it’s all been under
very specific compassionate use or research
protocols. I’m not sure about compassionate use,
but research protocols. So, now this sets the
standard for health care wherever you live,
whether it’s in a research hospital, a community
hospital, which we’re increasingly doing lots
of transplants. So, that’s, that’s really
the key thing about the HOPE Act to know.
MR. FRANCISCO RUIZ: Thank you. Our next question is:
what is the best way to enhance social behavior
changes as it pertains to HIV prevention,
especially in young people where we are
having high incidence of new infections?
So, how do we enhance social-behavioral
changes on the side of prevention?
DR. LATESHA ELOPRE: So, I do think we’re in
a state where we’re seeing growth in STIs and
especially among our adolescent populations. And
I think that probably one of the biggest things
we found with most of our prevention trials
is that we can engage adolescent populations,
but it’s hard to have them persist in care. And
I think probably a part of that is linked to
the first question that you asked in regards
to dissemination of information and really
getting the message to adolescent populations
in a manner in which they desire to have that
message be delivered to them. And then providing
them services in a manner in which they can easily
access those services. Confidentiality is a huge
issue in regards to people accessing services when
they’re adolescents, and it varies by state. In
regards to your ability to have private medical
health records, also varies by state, and it can
be effective in regards to protecting adolescents
from unintentional disclosure when they’re
trying to access sexual health services. So,
I think there’s all of these very special
situations that an adolescent has to
face when they’re trying to be sexually
healthy that our science needs to meet.
DR. LARON NELSON: Yeah, and you know,
adolescents…their preferences change so quickly.
I mean, not day-to-day, but like at 5 years out,
you’re sort of old again. Like you…you need a
new strategy. And so, that’s part [laughs] part
of the challenge, is staying current with what
adolescents, sort of, what’s in…what they’re into.
But I think really finding out what they’re into,
what makes them tick, and then finding a way to
do that. The challenge is that most of the folks
who are leading research are not adolescents,
they’re adults. And it kind of has to make sense
to you as an adult, and to the degree that
it makes more sense to you as an adult, it
makes less sense to them as an adolescent. And so,
somehow you have to find a way to be…be rigorous,
but—I don’t know how to say this—I want to say
pure, but give them what they want as they’ve
requested it, and try not to filter it as much
through your adult brain, because you’ll—I mean,
Dr. Donenberg knows this, she worked with
adolescents—you…[laughs] the more you do that,
the more you…it’ll lose credibility with them.
And that’s tough because as an adult person,
there’s some things that I think are appropriate.
And that…that is what ends up on the…getting
designed and getting implemented, which means
it’s…it will work really well for me, right?
Not as well for them. And so, that’s…that’s the
challenge. And there’s…our institutions regulate
that. IRBs regulate that. So, you…there
are things that have to balance, but I
would say trying ways to give them what they’ve
indicated that they want and how they wanted it.
DR. JEANNE MARRAZZO: [Crosstalk] DR. GERI DONENBERG: Can I add
to…oh.
DR. JEANNE MARRAZZO: Oh, I’m sorry. Go ahead.
DR. GERI DONENBERG: Oh, I was just going
to add—because I have spent the past 30
years working with adolescents—I think you
bring adolescents into the process. I think
there’s a…a very big movement on “nothing
about us without us” among young people. And
there are some terrific researchers doing work
around youth voices informing the messaging,
the dissemination, the research methods that you
use, a recruitment of participants, retention,
engagement. There are, you know, great folks
doing that work, and I think we can learn from
them. And they’re really directly engaging
young people in the process. We have advisory
boards that are youth driven and that are
comprised of youth. And I think choice,
again, becomes a big issue. And I’m just going
to do a plug that I think family members—and
I don’t mean like a parent necessarily, but a
trusted family member who that youth identifies
as someone they can relate to and would like
to have these conversations with—is someone
I think is a very underutilized and unleveraged
resource in our prevention efforts. And I really
think that’s an area that could…could work. And
then I’ll pass it over to Dr. Marrazzo. Sorry.
DR. JEANNE MARRAZZO: Yeah, sorry. I just wanted
to share a great quote that I heard when I was
in South Africa in August, because, to
me, again, I think one of the things we
haven’t talked about a lot is that we have
done so well treating HIV in many places,
that there isn’t the visibility of disability and
death that was so…that so shaped our growing up,
right? And our perceptions. And so, adolescents
already are invulnerable, right? Nothing bad’s
going to happen to them. On top of that, they’re
not seeing any of the really dire effects of HIV.
And I went to a PrEP clinic where young women
were being offered PrEP and one of them said,
“You know, why would I take a pill every day to
prevent myself from taking a pill every day?”
And so the idea was, “Why should I take daily PrEP
when, if I get infected, I can just take one pill
a day and I’ll be fine?” And to me, like, that is
like so classically, sort of, minimizing the risk
and…and just, sort of, “It doesn’t matter, you
know, I’ll be fine.” And so I…I …I think we have
to really also think hard about that because we
don’t have that leverage to…to sort of, frankly,
scare people the way that they were naturally
really scared before about getting HIV infected.
MR. FRANCISCO RUIZ: Thank you for that. And,
and this summer, I was in South Carolina,
not South Africa, and the same thing came up. “Why
am I taking a pill to take…to not take another
pill?” and so I think those are real conversations
that we need to have and why the potential of…you
…you know, the injectable conversations that
we’re having for those who don’t want to take
pills. And so…we, we’ve hit some of the questions
that are already…we have about a couple more one,
two-ish minutes left. I’ll ask one more question
and then see if any folks want to…who wants to
join this one. What do you see as the role of
community in HIV research taking place? Also,
how can we transition from our community
not only being participants in research,
but co-leading as partners in the development and
implementation of research? So again, how do…you
know, how do we intentionally engage our community
members in this work? And one…open for anyone.
DR. LARON NELSON: Yeah, I mean, I would just
go back to what Dr. Donenberg said about the
approach of…she mentioned youth, but the “nothing
about us without us”. I think that…that is it.
I think investigators who are typically leading
this have to adopt that. I think there are ways
you can incentivize them to adopt that because
they need you to participate. [laughs] And
if they aren’t participating on your terms,
then you don’t do it. They can’t do the study
without communities. I think the…I think recently,
I’ve seen announcements from NIH, or maybe CDC,
or both, that required sort of community
leadership of co-leadership of studies. I
think that is important because that structures
that expectation into the…the …the grant design
and that can make sure that happened. I…I think
the best work I’ve seen—certainly the best work
I’ve done—has been work that I’ve done in
collaboration with communities. And I think
without that, none…nothing that people might say
was innovative that I’ve ever done would’ve been
considered. So, it…it was only so because of
the support and direction from communities.
DR. LATESHA ELOPRE: I’ll just…100 percent agree
with that. I think the most meaningful aspect
of all the research that usually is done is led
and meaningfully engaging community members. And
I’ve been really excited in being able to see more
collaborations where you have a community member
as your co-I…as your PI leading publications
and saying, “This is the aspect of the science
that I think is the most important.” And then
also telling you in a meaningful way how do you
disseminate information to community so that it
actually impacts change. So, I think that this
is something that’s been really exciting, and I
think it’s actually what I…[laughs] led to all of
us being so invested from a government standpoint
and epidemic was community advocating and saying,
“We want you to invest in the end of
the HIV epidemic.” So, it makes sense,
naturally, that we are always engaging them and
listening to their voices as we move forward.
MR. FRANCISCO RUIZ: That is great. We have come
to the end of the Q&A. Thank you everyone who
was putting in questions, and hopefully
we…we try to answer most of them, but,
you know, time is of the essence, and I’m really
excited to pass it back to Captain Glenshaw. I
really hope that the conversations that we had
today, that the spirit of dialogue, sort of,
continues beyond just, sort of, the…the
webinar. And I know that this work is more
than just a scientific endeavor, but really,
it’s about the commitment to a humanity and
the work that we need to do collectively. So,
with that…passing it back to…to the Captain.
CAPT MARY GLENSHAW: [laughs] Thank you,
Francisco, Geri, Latesha, Eric, Jeanne,
and LaRon so much for today’s dynamic discussion,
highlighting opportunities to ensure that those
with and affected by HIV participate, inform,
and importantly, benefit from the life-changing
impact of research innovations. We appreciate all
of those watching today’s event for joining us and
for helping underscore the NIH role in supporting
the science that is truly the foundation of the
HIV response. Thank you sincerely to the NIH
colleagues who coordinated this event. We’re
so grateful for your dedication and commitment
to excellence in everything you do. Colleagues,
please pause to remember the estimated 42 million
lives lost to HIV-related causes, including more
than half a million people worldwide this
year alone. In closing, we honor the members
of our community whom we have lost since the last
World AIDS Day in 2023. Each of these remarkable
individuals dedicated their careers to improving
the health and well-being of people with HIV.
Among these, we remember Dr. Adaora Adimora,
an esteemed HIV researcher and professor of
medicine and epidemiology at the University
of North Carolina School of Medicine and
Gillings School of Global Public Health.
Adaora dedicated her career to studying the
socioeconomic and racial disparities in HIV
transmission and management with a particular
focus on the impact on women. A. Cornelius Baker,
a steadfast advocate for LGBTQ+ rights and people
with HIV, who dedicated his life to championing
health equity. Cornelius was instrumental in
building coalitions, creating a holistic approach
to HIV, and establishing multiple in…initiatives
and organizations that helped shape the federal
and community responses to HIV. He served as a
mentor to countless individuals, including me,
and was a long-time advisor of PEPFAR in the NIH
Office of AIDS Research. Ms. Hydeia Broadbent,
an AIDS activist who was born with HIV and became
a leading voice in the fight against the epidemic.
Adopted at 6 weeks old, Hydeia was ultimately
diagnosed with HIV when she was 3. She developed
AIDS at age 5 and was predicted to have a short
lifespan, but with early pediatric treatment,
she persevered. She used her 39 years of life
as a public spokesperson to destigmatize HIV,
raise awareness, and share messages of hope
and inspiration. Dr. Steven D. Douglas, who
explored the neuroimmunology of HIV and led the
development of novel targets for the treatment of
viral inflammation and infection. He spent much of
his remarkable career at the Children’s Hospital
of Philadelphia and as Professor of Pediatrics at
the Perlman School of Medicine at the University
of Pennsylvania. Dr. Gao Yeojie, a pioneer in
HIV activism who investigated the HIV epidemic
in China in the 1990s. While Dr. Gao’s work
earned her national and international acclaim,
she was kept under close state surveillance and
eventually fled to the U.S. Her efforts in HIV
prevention and anti-stigma education resulted in
the recognition of HIV in China and the creation
of policies to prevent and manage HIV. And lastly,
Dr. Victoria Anne Johnson, Professor Emeritus of
Infectious Diseases at the Department of Medicine
at The University of Alabama in Birmingham. Dr.
Johnson was a pioneer in HIV drug resistance
research and the use of combination antiretroviral
drug regimens that are now the standard approach
in HIV treatment. We are humbled and grateful for
their lifelong dedication of these remarkable
individuals. We join the entire HIV community
in celebrating their impact and drawing
inspiration from their legacies to…affirm
our commitment to the HIV movement. In closing,
on behalf of the NIH Office of AIDS Research,
thank you for joining today’s NIH Observance
of World AIDS Day. We invite you to sign up to
receive important updates from our office and our
program. This concludes today’s event. Thank you.