-Okay. The next speaker is Dr. Frederick Altice
at Yale University,
and we're really happy to have him present with us today.
Dr. Altice.
-Good afternoon, everybody.
-Good afternoon.
-It's really a pleasure to discuss
some integration of addiction,
HIV and tuberculosis treatment into primary care clinics,
which is an implementation science study
that is now underway in Ukraine.
And what I'm hoping to do is
to really try to provide a framework
by which this integration process occurs,
and I will walk you through a number of the steps
that we use with regard
to an implementation science strategy.
Next slide, please.
So first of all, let me just make sure
that my disclosures are listed here.
There will be no off-label discussion of any product
that will be discussed during the presentation.
And acknowledge a number of my partners including colleagues
from the Ukrainian Institute for Public Health Policy.
This work would also not be able to be done
without really very clear collaboration
with the Ukrainian Ministry of Health
and their Center for Public Health
within the country and within the government
as well as a number of other experts,
my colleagues at Yale University
and our project officer, Dionne Jones.
Next slide.
So just to sort of lay the framework
for our implementation science study,
there are now 109 implementation science frameworks.
This is one that we use, which is sometimes referred to
as the PARiHS framework
or the Promoting Action of Research Implementation
and Health Services.
And there are three critical elements that are essential,
and I'm going to walk through each of these.
One of them is, what is the evidence for your practice?
In this case, I'm mostly going to be focusing on the benefits
of opioid agonist therapies
and specifically methadone, in this context,
a number of systematic reviews,
but also data from Ukraine itself
sort of sets the stage for this.
I'm going to spend a little bit more time than that speaking
about the Ukrainian context
and how some of the things
that we might be doing in the U.S. may be different,
but also there may be some common themes
that will be crucial here,
so we'll focus on some of those factors
within the setting and within the country
and within the current movement
in their health-care reform.
And then I will spend a little bit more time
also focusing on the facilitation,
which involves coaching or support
that is really crucial for helping people
change their attitudes, habits, skills,
their way of thinking and working.
Next slide.
So just to put Ukraine into the global context,
over more or less the last 5 years,
HIV incidence has decreased globally,
but in the Eastern European and Central Asian region
and specifically in Ukraine,
it has increased by almost 60%.
This has occurred while the amount of the proportion
of patients who have been prescribed
antiretroviral therapy has increased over 200%.
But in Ukraine, the proportion that started out was much lower.
So coverage now in Ukraine is about 20%
whereas, globally, it's about 46%.
Mortality has decreased globally by about 25%,
and that amount is similarly in the reverse direction
for Ukraine and Eastern Europe.
And this is a region where the new infections
are driven primarily by people who inject drugs
and specifically injection of opioids,
and people who inject drugs account
for 71% of the 220,000 people
living with HIV in Ukraine.
Next slide.
So a little bit more in addition to the fact
that HIV is concentrated in key populations
and specifically people who inject drugs,
there's a couple of modeling studies
that help us sort of frame
why expanding medication-assisted therapies
like methadone and buprenorphine are key.
From a 2011 study from Sabina Alistar,
she really looked at the sort of scaled-up efforts
for both methadone
and for antiretroviral therapies
stratifying the efforts as low,
medium and high coverage.
And what she found from this study,
and she also combined coverage levels with methadone
and antiretroviral therapy
and really found that the most effective
HIV-prevention strategy for Ukraine,
and really importantly for this region,
is to scale up both
antiretroviral therapy and methadone.
But you still have an incredible amount of HIV prevention
that would occur with just high coverage of methadone,
and it was not quite as effective,
but it was close.
But what was important was, they did a secondary analysis,
and then they found that high scale-up
of methadone was the single most cost-effective strategy
to reduce new infections,
literally half of that then,
high coverage with methadone combined
with antiretroviral therapy.
And more recently, some work that we did with colleagues
in Ukraine looked at the criminal justice setting,
and getting individuals onto methadone therapy
and transitioning them to the community would reduce
HIV infections over the next 15 years by 20%.
So this is a region that would clearly benefit
from market scale-up.
And this has occurred in a setting
where opioid agonist therapies
with methadone were introduced in 2008
and buprenorphine in 2004.
It has a system where these treatments were introduced
not as treatment for addiction but as HIV prevention,
and so one of the challenges has been,
is that the people who have the keys
to the delivery of these treatments,
which are narcologists
or addiction treatment specialists,
are ones who have not really bought into the notion
that this is a treatment for addiction.
But they perceive it only as HIV prevention,
so they've not bought into it in the same sort of way
as, let's say,
an infectious disease specialist might.
This is also a country where health care is derived
from the former Soviet system
where health care is specialized.
It is siloed.
But one of the new signals that has happened in the last 2 years
is there has been a new mandate
by the Ministry of Health to strengthen primary care,
which is one of the reasons
why we had the incredible opportunity
to help guide the policies around health-care integration.
We've learned along the way as part of the context
that scaling up these opioid agonist therapies
has been hindered both by patient-level factors
in terms of them not believing
that it's effective and similarly by providers
and the structural way
in the way the care is delivered.
It's highly regulated and tightly driven
although new legislative changes in 2016, the Order 200,
which governs this delivery of opioid agonist therapies,
has been recently changed,
and it allows for methadone and buprenorphine
to be delivered in primary care settings,
which is aligned with the national strategy
to reform health care.
Next slide.
So just in terms of how there is an important relationship
between addiction, HIV and TB in Ukraine,
there are almost 350,000 people
who inject drugs, mostly of opioids,
but coverage with opioid agonist therapy
is still less than 3%.
And in order to reverse the trends of HIV transmission,
the international target sets this coverage
at somewhere that it should be, somewhere at 20% or greater.
Also among the 220,000 people living with HIV,
71% of people who inject drugs
and only 20% are on antiretroviral therapy,
but yet the international targets
are setting it at 90% should be diagnosed.
90% of those should be on antiretroviral therapy,
and 90% of those should be virally suppressed.
So if you just look at antiretroviral coverage,
that would be 81% of all the people living with HIV,
and it's much less than that.
And then, of course, they've had just last year,
9,000 AIDS-related deaths per year
that has actually been increasing,
and half of those are related to TB.
Next slide.
So this new health-care-reform strategy that's underway
is focused, right now,
on strengthening primary care,
and the idea is to reduce some of the bottlenecks
in some of the secondary and tertiary-care settings.
The governance of opioid agonist therapies with methadone
and buprenorphine now allows for the first time
for this treatment
to be introduced into primary care services.
I'm going to present some preliminary data
that we did as part of the pilot.
It makes opioid agonist therapy more convenient to patients.
Patients no longer have to travel as much,
and it potentially allows for it
to be delivered in their own communities.
And one of the new innovations that has been also allowed
within the country is distance-based learning
using a Project-ECHO-like platform,
which I will describe a little bit later,
which can provide the necessary facilitation
or coaching necessary for providers
to ensure that they develop
the skill sets that they need, that they are comfortable
prescribing treatments for HIV, TB and addiction
and allowing these sorts of services
to be integrated
for the first time into these settings.
Next slide.
So one of the questions on why this research in Ukraine
may have some relevance to the U.S.
although the Senate has just released their new
Affordable Care Act revisions, as it were, or removal,
and one of the things that's important is
that it allows for some task-shifting
to actually happen into primary care,
and we know that that works from a number
of different systematic reviews.
We know that the WHO
and the International Association for Physicians
in AIDS Care recommend integration of these services
for people who inject drugs.
We know that, independently,
the provision of opioid agonist therapies improves both HIV
and TB treatment outcomes,
and it allows for a more efficient
delivery of health care.
But how one does that in these diverse settings
is now poorly characterized,
so we hope to seek some reparation for that.
And the integration does not happen
unless there is an effective implementation plan,
which really involves facilitation and coaching.
Next slide.
So part of the other rationale for why to do this
is that patients with psychiatric
or substance-use disorders,
on average, die 25 years earlier than those without it,
and most of the reasons is not for drug-related problems.
It's mostly due to undiagnosed
and untreated primary care problems,
so this sort of integration would allow
for more direct access to primary care services.
We showed previously through a HRSA special project
of national significance,
called the Beehives Initiative, that integrating buprenorphine
into HIV clinics
significantly increased antiretroviral prescription
and viral suppression levels,
so it provides some basis for doing some of this work
but now moving it to primary care,
and similarly integrating buprenorphine
into federally qualified health centers,
using a Project-ECHO-type strategy,
significantly improved nine quality health indicators,
most of which were primary-care-related
such as screening for diabetes, hypertension,
management of a number of other co-occurring disorders.
And then I will present some data now
from our pilot study of integration
of methadone into two primary care clinics
in two cities in Ukraine
that sort of sets the stage
for what we're hoping to eventually show
within a clustered randomized control trial.
Next slide.
Some of the questions that we're going to be asking
as part of the trial that I'll present is,
will integrating the services result
in similar addiction treatment outcomes?
The reason why this is important
is that the addiction treatment experts have concerns
that primary care doctors can't do as good of a job.
The other question is, will the integration result
in improved screening
for treatments of other conditions
such as HIV, TB, diabetes, hypertension,
breast cancer, et cetera?
And then some of the other questions will be is,
will the stigma experienced by people who inject drugs
and, more importantly, people living with HIV
and the attitudes by medical personnel
towards these individuals decrease
through increased contact
with people who inject drugs?
And then part of the health-care reform within Ukraine
is trying to figure out how to finance this.
The health-care system has not
traditionally had financial incentives,
and so we are planning to introduce
a pay-for-performance strategy
to improve the quality of care that's provided
and see whether that adds any incremental benefit
just beyond integration.
And then the other question will be regarding adoption is,
can these primary care clinicians
become more expert at providing health care
and then sort of get their colleagues
within other primary care settings
to adopt these practices?
Next slide.
So these were some feasibility outcomes in our pilot study.
And one of the questions asked is,
will patients remain on addiction treatment
in a similar sort of way
as they would if they were maintained
within a specialty care setting?
There were just about a little bit
over 100 patients in the trial,
and 50% of the patients were transferred to primary care
as stabilized patients
from these addiction specialty clinics,
and another half of them
were newly initiated on methadone
by the primary care doctors.
And what you can see is the continuation
of treatment versus the transfer.
The 6-month retention was essentially similar.
It was 89% versus 94%.
And then the patients who were newly initiating therapy,
the retention rate at 6 months was 83%,
which is slighter higher than we saw for new initiates
into methadone treatment within the same regions.
It was 83% versus 79% at 6 months.
So the data really, to answer the first question,
is that these primary care doctors
with adequate training
are able to manage these patients.
Now, they also had the option of calling up
the addiction treatment experts for assistance
if they needed it,
so they did have that sort of support
but not day-to-day coaching.
You see that the reasons why they dropped out was,
either they developed tuberculosis
and got transferred to a different center for care.
There were a few deaths, a handful of participants
who were incarcerated, and one person moved.
Next slide.
So then some of the other important questions
that we raised,
and this is what happens at patient-level outcomes,
and we used standardized scales to look at this,
and one of the things that was very clear was
that the level of stigma experienced
by the people who transferred
from the addiction treatment specialty setting
to the primary care setting significantly reduced.
In other words, they felt like they were more normalized
within this care setting.
Their health-related quality of life improved.
And these were individuals who did not have
much trust in physicians,
but they developed a trusting relationship
with their primary care clinician.
Looking at the reverse, which is what happens with providers,
we did some qualitative research
and did chart review,
and we found that these primary care providers
were much more willing to screen and diagnose
and to help manage patients with HIV and hep C.
They facilitated the initiation of antiretroviral therapy
in patients who were HIV-infected,
and this was about 50% of the patients.
And they managed to diagnose and treat a number of routine
primary medical care conditions,
which were things that were not being done
in an addiction specialty clinic setting.
One of the things that we learned from this
is that we trained the providers at baseline,
but they got no additional coaching aside
from being able to pick up a phone
and call an expert.
And what they did identify was that they desperately
needed some ongoing coaching.
They needed to be able to present their cases
and to get some feedback.
And then they also requested some additional screening
and treatment of depression,
which they recognized was high,
but they weren't really sure how to do that.
Next slide.
So here are some of the data looking at the way
that staff perceived people
who inject drugs and patients with HIV over time.
In the light blue bar, this is before the intervention started,
and the dark blue is 6 months afterwards.
And as you can see, their attitudes
towards general patients
or those patients with diabetes or hypertension,
there was really no significant difference
between the ways that the providers viewed patients.
But when you start looking at drug-using patients,
their attitudes became more positive
towards drug-using patients
and similarly for patients with HIV
because they were repeatedly coming in and being seen.
So the contact hypothesis bore out positively in this case.
Next slide.
And so this is a slide that's going to build,
but the traditional model of health care
for specialized care is that there is sort of a dyad
of a physician or a clinician
and a patient that gets seen for independent care,
let's say, at the primary care level.
If you could advance one.
No, no. Go back.
This slide is supposed to build.
There should be a build that happens as part of this slide,
but if it doesn't, what ends up happening
in the noncollaborative referral model is that a patient
will go see their primary care doctor,
and then they often get referred,
let's say, to the HIV specialist,
the TB specialist,
the addiction treatment specialist,
and so there's a certain amount of challenges
that are imposed upon the patient to go get care
from multiple different providers.
If we could advance this just one more.
What ends up happening with this ECHO-like model,
which is an interactive learning environment,
is that you develop a core group of faculty specialists.
In this case, for our group, we're going to be
having an addiction treatment specialist,
an HIV specialist and a TB specialist
as well as somebody
from the Center For Primary Care for Ukraine.
And then what will happen is they will come together
through learning hubs.
Advance just one more, please.
And they will have doctor-patient teams,
these interdisciplinary teams,
that will be scattered throughout the country
so that they will all eventually
get ongoing didactic learning
followed by case-based presentations.
Advance this a little bit more.
Then that will disseminate through this telehealth
and video-conferencing system...
Advance one more please.
...so that other individuals
within the clinical care settings will adopt this
as they see people
getting skills within this setting.
Advance it again, please.
And again.
Next slide, please.
And so that is the Project ECHO type of learning,
so it essentially democratizes the way
that patients can get their care.
What we're doing in our trial is we are doing
a cluster randomized control trial.
It will be occurring in 12 cities throughout Ukraine,
and within each city,
there will be three sites
where patients will be randomized.
So we'll have a total of 36 sites,
and there will be almost 1,500 patients
enrolled in the study.
Patients will get randomized
either to get their addiction treatment
in a specialty care setting versus in one of two
matched integrated care settings.
One of the integrated care sites
will not have a paper performance incentive structure
whereas the other one will,
and what will happen is that the two primary care sites,
they will learn the necessary skills
to do HIV, TB and methadone treatment
and see implementation strategy in those two.
And the group that get the pay-for-performance incentives,
they will get paid
for achieving quality health indicators
that I'll talk a little bit more about.
The primary outcomes are at the service level,
and that is screening, adoption and treatment
for a list of health indicators achieved.
And then the secondary outcomes at the service level
is the attitudes towards people who inject drugs
and people living with HIV.
At the patient-level outcomes,
which is a little bit more distance,
we'll be looking at a comprehensive
quality health indicator score
that comprises 11 primary care
HIV, TB and addiction treatment outcomes.
That was developed through the Delphi method,
and then we'll be looking at
some health-related quality of life
and individual quality of health indicator scores.
Next slide.
So what have we learned thus far as part of this process
that we have leaders at the government
who are incredibly supportive of this research
because they need it to help guide their policies
so that they can make changes during their health-care reform.
We've been able to establish national experts,
including those who provide
some of the distance-based learning modules and content.
And we've added a couple on mental illness and hepatitis C
since hepatitis C is now becoming
a treatment option in Ukraine,
especially focused on patients living with HIV,
and we pulled together a group of national
and international experts
using the Delphi method
for defining what the quality health indicators
are going to be, not only for primary care
but for HIV and TB and addiction, actually.
And we've established our pay-for-performance indicators,
which are based on these quality health indicators
so that individuals within the study know
what it is that they need to achieve in order
to earn the pay-for-performance bonus.
And then we have created extra coaching
that's needed to help guide the primary
health-care centers with compliance
with some of these very rigid guidelines
around prescribing methadone.
And we've had some minor challenges
with equipping the sites for the distance-based learning
that is 3G Internet accessibility.
They don't use electronic medical records,
so we're having to use some paper-based systems
and some of our referral systems.
Next slide.
So I'll summarize that I think that,
depending upon what happens
with the Affordable Care Act in the U.S.,
there could be some important implications,
especially as we think about how to strengthen primary care.
We know that this will perhaps help with the guidance
for supporting integrated care by the CDC.
And one of the things that might be a thought is, you know,
if a pay-for-performance strategy
might be ways to inform the way
that Ryan White services are distributed
with regard to quality outcome.
And then one of the things
that will be probably true for Ukraine
is that it could transform
the health-care delivery strategy,
and it may have some implications
depending upon what happens with health care in this country.
One of the issues is to really affirm
and establish major competencies in primary care delivery
that moves outside of its traditional scope
and also to reform clinician payments
that reward good work.
This could be true for rewarding sites
that do good Ryan White care.
And I think for the case of Ukraine and potentially
throughout the whole region
of Eastern Europe and Central Asia
is that it will create national experts in addiction,
HIV and TB and primary care
to help evolve this field
so that other countries in this region
that struggle with the same problems
will be able to utilize these services.
Thank you very much.
-Thank you, Dr. Altice, for your presentation.
We have one question for you.
How did you choose Ukraine as site for these studies
given problematic USSR historical approach
to mental health and substance use
and the fact that Ukraine is
on the transit route of Afghan heroin
into Europe, both big challenges?
-So those are excellent questions,
and I should have addressed some of them in the contextual area.
So we chose Ukraine for a couple of reasons.
One is, aside from Russia,
which has complete opposition
to any kind of opioid agonist therapies, Ukraine,
unlike that, actually does have a system in place.
We were involved in introducing it in 2004,
and so that was one of the reasons is,
we had a network.
There were a couple of other things
that were really important.
One is that we had done a fair amount of work
understanding how to expand medication-assisted therapies
within a country given the Afghan route and opioids.
And we also recognized that Ukraine was a real leader,
a thought leader, for the region,
and so there is both pressure from Russia
to sort of to really stall the expansion
of medication-assisted therapies in Ukraine,
which has been trying to sort of push this.
So it was sort of their regional leadership,
the fact that we had done a fair amount of work already
looking at expanding it into other settings.
We had done some integrated care work there as well.
But none of it had been in the primary care.
And in fact, our previous work had been part of the national
health-care reform act in order
to sort of move things into primary care
and to find alternative ways
outside a specialty care setting
in order to deliver these services.
So that together was part of the reason for why Ukraine.
And I've also been...
And my team has been working with colleagues
there since 2004,
so we have a long-standing relationship.
-Thank you again.
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