REALTIME FILE

TREATMENT ACTION GROUP
DEMANDING A HIGHER STANDARD OF TB CARE:
NEW TOOLS, NEW CHALLENGES, NEW APPROACHES 
TO IMPROVING TB DIAGNOSIS
SEPTEMBER 3, 2020
8:00 A.M. EST

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This text is being provided in a rough draft format.  It is not a verbatim transcript.  Communication Access Realtime Translation (CART) is provided in order to facilitate communication credibility and may not be a totally verbatim record of proceedings.
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     >> DAVID BRANIGAN:  Welcome everyone to today’s webinar, Demanding a Higher Standard of TB Care: New tools, new challenges, new approaches to improving TB diagnosis. The first webinar on treatment for drug‑resistant TB was held yesterday.  The slides and video of both webinars will be available soon at the link in the yellow box to the left.  
On our right is the agenda for today.  We will be joined by some amazing TB advocates.  
     Adebola will start us off for diagnostic testing for DR‑TB and TB.  Dr. Pai will walk us through the tools we have to realize the highest standard of care for TB diagnosis.  We will also talk about how countries should scale up rapid molecular tests as the initial TB test and LAM testing among people living with HIV/AIDS.  We will also talk about holding actors accountable to maintain and improve TB diagnostic services in the context of COVID‑19.  
	We will then move into the question and answer segment that will be facilitated by Lynnette Mabote of TAG.  
	An Activist’s Guide to Tuberculosis Diagnostic Tools is part of the signature Activist’s Guide series.  It was recently released alongside An Activist’s Guide to Treatment for DR‑TB.  Earlier this year we released An Activist’s Guide to LAM Testing for People with HIV/AIDS and updated the Activist’s Guide to Rifapentine for Treatment of TB Infection.  They can be found on TAG's website.  As TB diagnostic tools evolve, so do the recommendations and guidance from the World Health Organization on how they should be used in country programs to realize the highest standard of care for TB diagnosis and also to realize the rights to health and to science.  
	All people at risk of TB have the right to TB diagnostic testing at the highest standard of care.  An Activist Guide to TB Diagnostic Tools details available tools for TB screening and diagnosis, and for TB infection, and describes how they should be used in country programs according to WHO recommendations.  
	It provides detailed tables with information on sensitivity, specificity and price, along with the WHO recommendations that correspond with the different tools.  It discusses access barriers to TB diagnostic testing such as high prices and lack of price transparency, insufficient implementation of tools and insufficient investment in the rollout of new diagnostic tools.  Finally it suggests actions activists can take to overcome barriers and promote equitable access for all people at risk of TB.  
	Note that the latest WHO recommended treatment regimens are covered in depth in TAG's new An Activist’s Guide to Treatment for DR-TB.  The TB diagnostic pathway is the entry point through which people with TB access the TB cascade of care.  
	Under optimal circumstances, TB‑affected communities have awareness of TB prevention and care and are regularly offered TB screening and testing followed by TB treatment or TB preventive therapy as appropriate.  In actuality, however, many people seek care only after developing symptoms of active TB, and they often face stigma when doing so.  
	Of those who are diagnosed, many do not receive drug susceptibility testing necessary to inform optimal treatment regimens, and many people at high risk of TB don't receive TB preventive therapy.  
Today's webinar will address all of these issues and more.  We're now going to start with our first presentation on Access to Diagnostic Testing for TB and DR‑TB at the Community Level: Challenges and Proposed Solutions.  
     The presenter is Adebola Adams.  She's a member of TB People of Nigeria and holds a master's in urban and regional planning.  I'm going to pass it over to you now.  
     >> ADEBOLA TOPE ADAMS:  Thank you, David.  Welcome everyone.  I'll be talking about access and diagnostic testing for TB and DR‑TB at the community level.  Challenges and proposed solutions.  Next slide, please.  
	Let me start by saying that diagnostic testing is the bedrock of any medical treatment, be it curative, palliative, or preventive.  It is a compass that leads to accuracy in medical treatments.  
I will be reviewing the importance of TB diagnostic testing on treatment and on people.  On treatment it determines the extent or degree of illness or sickness, the state of the illness or a particular sickness.  
	Two, it enhances the effectiveness of the cost of medical treatment.  Three, it ensures avoidance or stoppage of the wrong medication with precision in diagnosis.  
	Avoidance is achieved of the wrong medication, and on people it's important to know that TB diagnostic testing will secure lives finances, job opportunities, marriages.  I remember about this.  I had colleagues who were abandoned by their spouses because of what they were going through.  
	Number two, it reduces the dependence on relatives.  Number three, it reduces the high costs of treatment.  If it is caught early, there will be no need for going round and round for treatment.  And finally, and most importantly, it saves time.  Next slide, please.  
	I would like to take us through my diagnostic journey.  In March 2004 when I started to feel sick, I went to a private clinic and was asked to take a chest x‑ray based on my symptoms.  It was discovered that I had pulmonary tuberculosis.  I was given drugs.  In August of 2004 there was a relapse, and I was asked to go to the chest clinic to get tested through the AFB microscopy test, which came out positive, TB‑positive.  
	In August 2006, it was a chest x‑ray that discovered that I had TB, just TB.  It went on a through March 2007, when I had an AFB smear microcopy.  In August of 2008 at the university hospital, I had my sample sent to Belgium.  
	In 2009 it got worse because at that time I was already coughing blood.  So I have to send my sample to a private center at Abuja for culture in 2009.  
	In 2010 I also had AFB smear microscopy at the center.  It was on July 5, 2010 I was asked to go to the admission into the MDR‑TB center based on the results that went to 2008 in Belgium.  That was where I spent close to seven months, and I thank God because the rest is history now.  
	In retrospect I may not have went through all I went through.  That was seven hard years.  And there was difficulty at the time, moving on I have identified some challenges and some proposed solutions.  
	Next slide, please.  Number one challenge is the stigma, and somehow it reflects in every other challenge.  Stigma, a lot of people only know that TB is contagious, and after that nothing again.  So they tend to run away when they know that somebody has TB, and it's interesting ‑‑ don't use my plate.  You cannot use my cup or this.  
	Number two, there is a low‑level or lack of awareness.  When people hear TB, they don't know what it is or what the symptoms are and how to get tested and what to do and where to go.  Three, inadequate tuberculosis diagnostic testing centers.  
	There are a lower level of accessibility to TB diagnostic testing centers.  Four is transportation issues.  It is not so easy to get to TB diagnostic centers, and when we people do, they know they will be stigmatized.  If they test positive, they want to go to a far place to get tested.  
	The next one, there is insufficient attention on the part of major stakeholders such as the government.  The awareness for TB and the attention given to TB is rather low compared with how it spreads.  
Last on my challenge list is the poor engagement or involvement of associations at the community level.  Based on all this, I have come up with some proposed challenges.  Next slide, please.  
     They include first and foremost governments in collaboration with civil society not‑for‑profit organizations and community based organizations to strengthen Ministries of Health to better address issues of TB diagnosis, treatment management, and prevention if possible.  A ministry of infectious diseases can be set up to deal with this demand.  If caught early, TB will not spread the way it spreads today.  
	Two, educate the public through digital and print media to raise awareness around TB symptoms and to reduce stigma.  If people understand the nature of TB, they'll be open and willing to help people around them who present with TB symptoms and reduced stigma. 
	The next is of the proposed solution is engage all stakeholders in the community with information and training to facilitate rapid referral for TB diagnostic testing.  All stakeholders -- start from the local hairdresser, the dressmaker, the head of the associations, the mechanics, the plumbers, the artisans all over, and most importantly the drugstore owner because they are the people ‑‑ they are the people who attend to the community and every symptom of sickness.  
	People go to them first before any other place.  The next will be to procure TB diagnostic tests that can be performed close to the point of care.  At this juncture, I would suggest the establishment of mobile testing centers.   
	Especially with the advent of the Truenat test, it's possible, it doesn't require electricity and just batteries.  We can achieve mobile testing centers in the local governments, which will have a time that it goes to each area to get people tested and admit and refer them if positive to treatment centers.  
	The next on my list of proposed solutions is provide financial and other social supports to people who test positive for TB or DR‑TB.  DR‑TB is something that deals with mostly the chest.  
	We know that the chest is a seat of power, the seat of energy to do any work.  If people who have tested positive for TB are empowered financially and nutritionally it will encourage other people who are hiding but presenting with such symptoms to show up for tests since they are short of the support from the government and other bodies.  
	And finally, to establish national help lines for people to get information on TB and how to access TB services.  This is very important.  
	As we all know, knowledge is power.  When people are empowered just from the management of COVID‑19.  On our phones we get messages from time to time.  If you're presenting with these symptoms, call this line.  This is what to do.  
	It will help in arresting this kind of TB and making diagnostics testing very, very efficient.  Thank you for listening.  Over to you, David.  
     >> DAVID BRANIGAN:  Thank you so much for sharing your story with us, and Tope's story really speaks to the challenges many face in the community level in accessing TB diagnostic services.  For her it took seven years to have a correct diagnosis and drugs for DR-TB, and the impacts of this I could not imagine.  Thank you very much.  
	So we would ‑‑ I want to remind people that you can enter any of your questions into the question or chat feature.  Our next presentation will be on the Highest Standard of Care for TB Diagnosis: the tools we have and how they should be used together.  Our presenter will be Dr. Madhu Pai, the Canada research chair in epidemiology and global health at McGill University in Montreal.  
	He's also the director of the McGill TB Center and he serves as the chair of the public/private mix PPM working group of the Stop TB Partnership.  Over to you.  
     >> DR. MADHUKAR PAI:  Thank you, David.  Hi, everyone.  Thank you for joining us on this panel.  Next slide, please.  
	So we now have as we know from the consolidated guidelines WHO put out a couple of months ago, we have a wonderful suite of tests ranging from liquid cultures, rapid molecular tests, line probe assays and TB‑LAM and also tests for latent TB infection.  One technology where we've done so well, I think, as a community in the last several years is the molecular tests.  
	The advent of more decentralized technology, and through that portable systems like GeneXpert Edge and LAM that can be done in a decentralized setting is a really positive move in the last years.  
They're hoping that this will continue with more decentralized, easier‑to‑use options.  
     We're also looking at several centralized testing options.  Sequencing is becoming cheaper and easier and predictably way more important in the coming years as a way to rapidly understand which drugs we might use for a patient or not.  Next slide.  
     So if we wanted to, one slide before that, David.  Yes.  
If we wanted to, I think we're really in a great place today in 2020 to re‑imagine how TB care is delivered.  To do that we have to move away from one at a time to think more as an entire system.  If we could have a dream health system, what would it look like?  We would have, you know, systemic screening in place.  
	We would, I hope, have a rapid triage test right now, and we have lots of exciting artificial intelligence‑based software options for reading a digital assay.  We have more sensitive LAM technologies coming on board and we have decentralized diagnostics already in place.  If you could have sequencing done for those who have the resistance, we would have come a long way from how TB was diagnosed in the past.  
	Then we also have regimens now for DR‑TB and for latent TB, and we have a host of patient support systems and technologies, everything from a call center to video to cashless payments and everything can be connected to an ICT system with a dashboard and they can even go paper‑free, I hope, soon.  
	So none of this is impossible.  The tools all exist, but I think they haven't come together to serve people who need them the most, and we have to move towards a more complete way of thinking about supporting patients through the entire cascade rather than just one tool or technology at a time.  So if you go to the website reimaginingtbcare.org, these sort of care models are available for you to look at.  Next slide.  
	But as is often the case with TB and I'm sure this also came up in yesterday's webinar, the actual update of new technologies, even the best WHO best‑in‑class tools have been very slow in our TB field.  It has taken us ten years to move the needle on the GeneXpert issue, and even today we still have many countries that are still very reliant on smears as a front line test, not a rapid molecular test, so we have a long way to go even today.  
	You look at something like LAM, even though the policy is much stronger now than it was in the past, we only have about five of the 24 countries that we surveyed where you did a LAM test and it's being deployed and used in a routine manner.  
	So uptake of new tools continuing to be depressingly slow, and this is a critical issue for us working on advocating for innovations to be taken up in the TB space.  Next slide.  
	And as I wrote earlier that the BPaL regimen was approved.  It doesn't mean they will deliver themselves.  Even if you have a fantastic, new high‑sensitivity LAM test in the future, there is no guarantee that it will reach people.  
	We have to pull so many, you know, loose threads in TB and advocate relentless and work with multiple stakeholders to make sure products are there, accessible and affordable and actually taken up.  So what happens in TB medicine is also happening in TB diagnostics.  We have to do better that what we've done, and that's why the advocacy and activist guidelines are so critical to push for a greater update.  Next slide.  
	Now, I can't not talk about COVID‑19 in the context that we are in today.  The amount of damage we are seeing because of COVID threatens to be catastrophic, actually.  It turns out that it's not just TB.  Every aspect of global health is desperately compromised right now.  
	There's a dip in notification that’s pretty much the tip of the iceberg.  What we're not seeing is how many people who missed their therapy, how many people are running around desperately looking for care and how many people for whom COVID and TB is getting confused.  The amount of underreporting we're seeing in COVID and in TB is all super worrying and scary.  It looks like we already slipped behind our end TB timelines by five or more years.  
	Next slide.  Now the issue here is how do we move forward?  I think the predictions from models are quite dire, and we are going to look at a huge number of additional cases if we're not proactive.  Next slide.  
	So in terms of proactivity or some kind of damage control you start to see, we've been working with many stakeholders.  This is something we did with the Global TB Caucus on some key issues that we can all focus on as a community that we should all advocate for not stopping ongoing TB services.  We must recover routine health services, and TB is a routine, essential health service.  
	I'm very nervous about potential stock-outs of TB medicine in the future, and this is to a great extent tied with the fact that China and India are the global, you know, factories for TB medicine, first line as well as second line drugs and they're all struggling and suffering in this time.  
	We have to advocate for not stopping routine TB testing.  If all the attention is going to run off to COVID testing and routine TB testing comes to a halt, we will have millions of people backlogged and we've not diagnosed them.  
	There is a potential to run COVID and TB testing in parallel so that we don't drop the TB testing option.  We'll talk more about that in a second.  We have to advocate for switching to all oral medicine.  Injectables are a nonstarter in this crisis.  This is a great time to bury injectables forever and make sure we switch to oral regimens.  
	I already spoke about the drug supply issue, and we must all advocate for India and China to ramp up production of TB supplies so that we're not left in the lurch in the coming months and years.  Next slide.  
	I want to add a few thoughts.  I'm keen to know the answers to the questions.  We got a grant with colleagues to work on this as have others.  
	So on one hand we could say TB and COVID have similar symptoms, cough and fever.  Therefore, it makes complete sense to integrate testing of these two.  Indeed, countries like India, for example, have just announced a policy for the screening.  That is, everyone with TB should be tested individually, and everyone with COVID or COVID‑like symptoms should be tested for TB.  In some sense it does make sense because they're both respiratory infections with similar symptoms.  
	The second good thing here is we have multi‑disease platforms such as GeneXpert and Abbott or Roche molecular technologies.  These disease platforms can and should potentially handle TB as well as COVID testing at the same time simultaneously, asynchronously if possible.  
	So I think it makes sense.  Here are some things that worry me.  Do we really advocate for this screening as a critical thing?  Before we do that, I think we owe it to ourselves to ask a few hard questions.  
	Firstly, is it even feasible to run both tests on the same biological sample during the same visit?  All right.  Is that desirable?  If so, is it feasible?  
	For example, if we collect sputum for GeneXpert testing but need a nasopharyngeal swab for COVID testing, it's harder.  There's some data that saliva may be good for COVID testing, but does that mean saliva will work on TB?  It may not.  If we have to get the patient in multiple times, then I fear integration is more challenging than we think.  
	Are we thinking of the right groups?  We think of people with a chronic cough that is insidious and slowly progresses, while COVID is acute cough with fever and slightly different symptoms.  
	I'm worried if we chase both in the same set of people --if they overlap -- think of it as a Venn diagram.  I'm not sure of the overlap of the Venn diagram right now.  
	You do testing with three days of acute coughing, are we wasting time with TB looking like a needle in the haystack, why we should focus our attention on people with chronic coughs.  
	I'm not sure what the yield and cost‑effectiveness of running two tests on every single patient is.  I don't want us to waste precious resources if we're barking up the wrong tree.  Lastly, I'm really worried about bottlenecks.  
	Globally, even if the richest of countries, COVID testing is a bottleneck.  Let's please acknowledge that.  
	You cannot get a COVID test easily anywhere on the planet right now.  Now, if we say everybody with TB should also be tested for COVID and everybody for COVID should also be tested for TB, we are creating two massive bottlenecks.  That means that countries need ridiculous molecular capabilities to truly live to the spirit of bidirectional guidelines and pull it off.  Until then it will remain a paper guideline.  
	So unless we are assured of ramping up molecular capacity to crazy levels, this is not an easy thing to implement.  I don't want any bottleneck to delay someone's TB diagnosis.  That advocacy I can get behind.  
	In other words, I'm perfectly fine saying to do bidirectional screening if possible, but at no cost should a person's TB diagnosis be delayed just because a COVID test is not available.  That, to me, is unacceptable.  I'm not going to wait for a COVID test before testing for TB.  If somebody has TB symptoms, we should test right away.  COVID is a nice test to do, but if it's not available it shouldn't be a bottleneck.  
	Lastly, we will talk more about this.  I'm really worried that every single diagnostic company in the world is fully focused on COVID‑19.  Please, let's not imagine TB will get priority in this situation.  No company is giving TB priority even on the best of days they didn't because TB was not considered a lucrative market.  COVID is a lucrative market for a company.  
	If you understand how the market behaves predictably, I can't imagine any company in the world giving TB diagnostics priority, especially for this seeing as a product barely making money as opposed to COVID which is more lucrative and in great demand right now.  We must advocate to make sure no company drops TB from the portfolio from R&D and manufacturing.  Thank you.  
     >> DAVID BRANIGAN:  Thank you so much for walking us through all of these issues.  Then the difficult question about bi-directional testing and the need to continue to really prioritize routine testing for tuberculosis.  
     Our next presentation will be on Translating Policy into Practice: Scaling up rapid molecular tests as the initial TB test for all and LAM testing among people living with HIV and AIDS.  Our presenter is Stijn Deborggraeve, diagnostics advisor at MSF Access Campaign.  He covers TB diagnostics as well as diagnostics for HIV and COVID and is based in Brussels, Belgium.  Over to you.  
     >> STIJN DEBORGGRAEVE:  Thank you, David.  Thanks a lot for the invitation to speak today in this webinar.  It's really important.  It's important for many stakeholders, to translate policy into practice for molecular tests as an initial test for all people with TB symptoms and for LAM testing with people living with HIV/AIDS.  Next slide.  
	WHO had guidelines and had diagnostic tests.  There's a range that's currently recommended by the WHO.  The first one is already a long time, it's already ten years in the recommendations by the WHO, which is the Xpert test as we all know.  
	So WHO strongly recommends to use Xpert as the initial test for all people with signs of TB and extrapulmonary TB.  Recently there was an additional, another molecular device Truenat that that was recently added to the WHO recommendations.  WHO management recommends it can be used and it may be used as an initial test for all people with signs of TB.  So awaiting evidence for extrapulmonary TB, but it can already be used for TB diagnosis.  
	The TB LAMP test is an isothermal near point of care molecular device.  WHO recommends that it can be used to replace microscopy.  So important here is it doesn't give you any information about the resistance, but it can be used to replace microscopy for people with signs of TB.  
	So these are the three rapid molecular diagnostic tests currently recommended by the WHO.  Next to these three you have a TB‑LAM test.  It's for the point of care and for diagnosis of TB in people living with HIV/AIDS.  WHO recommends to use this test for TB diagnosis in people living with HIV/AIDS and in both inpatients and outpatients.  
	So it's important to note that for HIV ‑‑ people with HIV and that do have signs of TB or DR‑TB, you can use or should use this test as much as possible irrespective of CD4 cell count.  Next slide please.  These are the recommendations by the WHO.  
	How much are these recommendations actually adopted in the policy by countries and how much are they used?  There's a difference between adoption and actually making the test available in a country.  So MSF together with the Stop TB Partnership, we have a series of “Out of Step” reports.
	These are reports in which we survey countries in terms of diagnostics and treatment of TB and if have taken the policies and implementation.  So there have been ‑‑ I think the first one was in 2014 and we had one in 2015.  The most recent was in 2017 when we surveyed 29 countries on their policies.  
	We are now in the process of finalizing the next version, which will be the “Step Up for TB” 2020 report, which will come out in one of the next weeks.  Then we surveyed 37 companies for the TB policies and also for the use of making available diagnostic tests.  So next slide, please.  
	So in our 2017 report what we have seen there is that from experts only half of the countries have this Xpert for all policy.  Out of these countries only 40% have made them available.  
	The new data we're analyzing, there's an increase.  We have seen a significant increase for the number of companies that have policy, however not 100%.  It's a bit disappointing because Xpert is already for ten years available.  It has already been recommended by the WHO for ten years.  So every single country should have this policy by now.  
	In terms of TB LAM, in 2017 only 7% of the countries that we surveyed, so 29 surveyed countries, only 7% have TB LAM for people living with HIV/AIDS.  None have made the test available in 2017.  
	In our 2020 data, we see an increase, and it's more or less matching with what the team have published recently in terms of TB LAM uptake where they see 46% of their countries surveyed that now have TB LAM in their policy, however, only less make it available.  It's quite some effort to do, quite some work to do in terms of production, but that's in terms of making tests available in the country.  
	That's also reflected if you look to the global report by WHO.  This is the report of 2019 where you see in this graph the percentage of notified TB cases with a bacteriol confirmation.  For 20 years we have a flattened curve, so only 50% of the TB notifications come with a bacterial confirmation.  Next slide.  
	So what should we do?  The first one is for countries.  Please make a rapid diagnostic for all policy available and at all health care levels.  
	There should be an inclusion of an efficient specimen system and make sure that the Xpert machines are placed strategically around the country that we refer to as much as possible for optimal access for every single patient.  Onto TB LAM, when we did the survey recently for the “Step Up for Tuberculosis” report, we also surveyed the countries.  
	What is the data for uptake of TB LAM to make it available?  The answer was it's not in the hands of a TB program.  
	This is a critical thing that countries should coordinate between the TB and HIV departments or programs and align the policies.  TB LAM should be adopted in both.  Importantly, countries should ask for available funds and money for the option of TB LAM, because it isn’t too often in the proposals.  Important TB LAM should be in the policies for inpatients and outpatients.  
	If there's clear published evidence it can save lives in inpatient and outpatient settings, and it should be at all health care system levels including the primary health care level.  
	Finally, for companies is we think community patient advocacy is really important to demand companies to scale up the rapid molecular availability and TB LAM testing for people with HIV/AIDS.  Stakeholders from the WHO, it’s very important there's adequate funding for countries to translate their policy into practice for implementation and scaling up the diagnostic testing.  
	This should be very clear recommendations and very straightforward, and the countries should be guided in adopting the policies and implementing the policies into practice.  Pretty important is that stakeholders also monitor diagnostic coverage to identify the gaps, where are the needs and where are the gaps and they have specific support to fill up the gaps in terms of gaps in diagnostic coverage.  
	Now, finally companies should make a rapid diagnostic test affordable.  This is one of the key answers that we got back from the 2020 report.  It's mainly the pricing of diagnostics, which is still too high.  
	For instance, the MSF Access Campaign together with the Treatment Action Group advocated for years for a lower price for the TB cartridges, given current volumes and given its low cost of goods for cartridges.  This should include service and maintenance.  
	Another feedback that we get from countries are broken machines, slow repair hampering optimal use.  So an important part of pricing for diagnostic testing includes the service and maintenance that would solve a lot of problems in the countries.  
	Companies should also support countries in scaling up transitions into new technologies.  The new technologies are really, really good, very important, but they're not taken up in the policies but also not used in the countries because countries aren't prepared.  In terms of TB LAM we need a more sensitive one.  
	The current sensitivity is 50%.  It saves lives so it's an important test at 50% sensitivity.  You can imagine if you can have a more sensitive TB LAM what the impact will be on diagnosis of TB among people living with HIV.  
	We know that Fujifilm, for instance, is working or has developed a more sensitive TB LAM.  It's going to be under evaluation and also independent clinical trials.  So we do hope to see this test come to the market quite soon in an affordable format and simple format.  We also know what it's like to work on a more sensitive device, more sensitive TB LAM, so there's hope we have more sensitive TB LAM tests available soon.  
	Finally, as we already have said, please, companies, do not displace TB test production for research and innovation in COVID.  Especially now we're in a momentum, let's say, in terms of scaling of TB diagnostics, in terms of policy adoption translation and especially in those hard times with COVID.  I think we cannot displace any patient care for TB including the diagnostic process.  Thank you very much.  
     >> DAVID BRANIGAN:  Thank you so much for that excellent presentation and for sharing all of that info on the adoption of policies and TB diagnostics.  We're looking forward to the new MSF and Stop TB Partnership “Step Up for TB” report coming out soon.  There's a link to the current ‑‑ or to the most recent one in the chat.  
	I would like to remind people that you can add any questions into the chat, and we will compile and address them in the question and answer segment at the end.  
	Now our next presentation is on Opportunities and Challenges for TB Diagnostics Advocacy in the Context of COVID‑19: Holding actors accountable and mobilizing political will for action.  Our presenter is Blessina Kumar.  She's worked with marginalized communities in Sudan and Indonesia.  She's one of the early advocates trained by TAG and a strong advocate for a rights‑based global TB response.  
	Over to you, Blessi.  
     >> BLESSINA KUMAR:  Thank you very much, David, for that introduction.  Thank you also, TAG, for coming up with this very valuable Activist’s Guide.  I know that many of us follow that really, really closely and read it and use it and also for organizing these webinars.  Next slide, please.  
	So a lot about ‑‑ next slide, please.  A lot about TB has already been shared by the others, so I'm not going to dwell on that too much.  
Just to say that with TB any way to step we're on weak footing.  We never had everything that was needed to address TB, to end TB.  However much we planned, whatever number of years we talked about, we really were on a weak footing.  Next slide, please.  
     Looking at TB diagnostics, that also we were really missing.  This was pre‑COVID, and we can't really blame COVID for this.  We were anyway missing people, 3 million of them.  They were under- or undiagnosed or if they were detected, they were not reported.  Next slide, please.  
	And some of the challenges called TB diagnostics, you know, we have to really listen to what the survivors are saying.  Like we had to speak.  So in the training that we conducted across Asia‑Pacific, Latin America and Africa and India with 187 TB survivors representing 28 countries, they identified getting the right diagnosis as a huge challenge in the whole cascade of care.  
	The top three -- lack of information, stigma, and costs --were the huge barriers to getting that right diagnosis.  Along with this, the lack of knowledge of doctors, because TB isn't something that comes first.  They're sent from pillar to post.  
	It took Tope seven years to get a diagnosis in this age, and there's lots of wrong diagnoses.  So they're treated for something and then come back for more diagnoses and the right treatment.  Then if they do manage to get to the laboratory, there are no stock available.  So some of these huge challenges that already existed with TB.  Next slide, please.  
	So with COVID we saw this new challenge, the impact definitely.  There was a lot of negative impact for TB for our first early stage community survey that was led by GCTA during the initial lockdown period.  The lockdown itself was a huge challenge.  Then there was transport.  There was a lot of fear because people couldn't understand.  
	There was a lot of people going back from the cities to their homes in the smaller towns and countries like India.  There was non-availability of health stuff.  There was redirection of staff.  
I mean, in India from the national TB program there was so many staff that were redirected to COVID.  
     Resources that were redirected.  Of course, there were nonfunctioning health centers, and there was absolutely no availability of social and nutrition support.  More recently the civil society and community survey that was done with different stakeholders with over 1,000 respondents, the responses are very similar, and this is a survey done in the middle of COVID.  
The report will be launched on the 15th of September.  Also it shows very, very similar challenges.  
	We talked about the TB modeling, and we know the disastrous effect COVID is having on TB by TB being pushed back further on the back burner.  Next slide, please.  Not just the modeling.  We really know that in countries -- we see a recent report from India that showed 60% reduction in case notification.  
	And we recently ‑‑ a recent Lancet article says not at the expense of other diagnoses.  We know that all diagnostic companies are really redirecting attention and product capacity to COVID‑19 testing.  This is really, really worrying for us.  
	You know, how do we ensure in this status that TB really doesn't miss out or fall off the radar?  And more worrying is the Lancet article on the diversion of resources through repurposing the existing tests.  Something for us to take note on and remember to advocate on this.  
	There's also a large decrease in case findings in India and other countries.  The supplies are being disrupted.  We've seen so much stockouts of TB drugs and TB diagnostics, the cartridges.  People are really running from pillar to post, and health centers to top it off are not functioning fully.  Next slide, please.  
	So having said that, what are some of the opportunities that COVID presents to us?  I'd like to call it push and pull.  We need to push people back to get what we want.  That is the highest quality of care for people that need it most, and we need to pull people up and hold them accountable.  Five areas we can look at, first is accessibility.  Where are these diagnostics available in the country?  Many times these are only available in large cities or big towns, but really miss out on those smaller towns and districts.  So very important to see where these are being placed.  
	Then availability.  We're seeing continuous stockout of cartridges not just in India but many other countries.  There's non-availability of staff.  The survivors identified lack of information just like Tope also said as being one of the biggest barriers.  
	How much of public health information is available and easily accessible?  Stigma is a huge issue.  
	Acceptability.  Our people with TB symptoms when they go to the health center, are they treated with dignity and self‑respect in a non-stigmatizing environment?  Affordability costs.  I know countries proudly say TB diagnostics are free of cost, but there are a lot of out‑of‑pocket costs to that.  
	Transport, loss of wages because the services are available only in those facilities that you have to actually miss a day's work to go and access them.  
	Also, then the question of fair pricing that is related to the cost of goods sold.  And then how appropriate are the diagnostics?  We just heard the WHO approves these diagnostic tools, but to reach the people who need them most, it can take years.  We cannot let this happen.  
	LAM has 50% of accuracy, but still is a good test.  Many countries have still not adopted it.  We're still dependent on smear microscopy, which is like 150 years ago.  We really are not moving with times when it comes to TB, so it's a question of rights, human rights, right to science and right to health.  Next slide, please.  
	And with COVID the opportunities really rest with the civil society.  We see that it was the civil society groups who initially wrote to health ministers, presidents, national TV programs regarding the effect on TB during the pandemic.  Civil society advocated and pushed back on high prices.  
	Most oppositions are civil organizations and we need to support that.  The efforts must continue.  We need real time data that civil society and communities make available and use that to advocate.  It is civil society organizations that are providing support for community groups and people seeking care on a daily basis, we link patients or people with symptoms to diagnostics.  We're getting appointments for them.  We're writing letters, and we're arranging transportation and social support.  This must continue.  
	Then the good campaign we launched in 2019, the Time for $5 campaign, we need to keep pushing for this, especially when the cartridge cost so much below that.  We need to keep pushing for that.  Next slide, please.  
	We need to push as a group.  There is also ‑‑ if we look at TB, there's a lot of political will.  Politics and parliamentarians have come on talking about TB.  Very quickly, let's get onto the bandwagon and be willing to talk about it.  National programs are being driven by COVID numbers, realtime data, daily deaths, daily infections.  We see that every day.  
	Research and development.  Very quickly we've seen so much investment into this.  Information so freely available.  If you call somebody in India, you have to spend the first 30 seconds listening to a message on COVID.  You have no choice.  You have to listen to it.  That's the dial tone.  That's the calling music that you hear.  
	Messaging three simple messages.  Wear a mask, wash your hands, maintain social distancing.  We need to really use these to leverage something similar for TB.  
	We're also seeing addressing barriers to access.  If someone is stigmatized as someone with COVID, they have to pay a fine.  It's being enforced. And then coming into this bidirectional testing for TB and COVID that their health minister recently announced, and the global TB community is lauding it.  
	I have my own concerns.  I think TB will still get left behind when we focus on this bidirectional testing.  We need to make sure there's adequate resources, tools necessary for doing both of this.  
The last two days there's been a campaign and people are coming to my house and locality testing for COVID.  Nothing about TB.  Nobody even knows this is being talked about.  
     So announcements are great, and the global community can applaud it, but we know that the ground level reality is very different and we need to keep pushing and pulling people up.  Next slide, please.  
So accountability.  How do we hold actors accountable?  
	There are some mechanisms that have been here for TB like the multi‑sector framework indicators that countries need to report on.  The missions program reveals community‑led monitoring, shadow reports and stakeholder surveys, et cetera.  If we look at COVID and want to learn from it, we know that data and numbers drive the response.  
	Every day the chief minister of Delhi comes on Facebook and gives these numbers.  So many new infections.  So many people hospitalized.  So many deaths, and this is what we're doing.  This has never happened for TB.  If we invest as much as we are doing for COVID in the past few months, if it had ever been done for TB, I think we would have ended TB a long time ago.  So numbers really matter.  
	And civil society and communities are the best players to hold actors accountable, but we must understand there's strength in numbers.  Many times we tend to do it alone.  One voice here and two voices there.  
	It's very easy to stop those voices, and nobody takes notice.  If we come together, we have seen some campaigns that are led by MSF where people came together.  Everyone should be on board.  
	If we say we're working for TB and are interested in saving lives, we have no choice to get onto that and not be fearful of rocking the boat.  Not be fearful about my next grant being stopped.  No, it will come, because they need to ‑‑ donors need to give it.  
	So we need to come together to make that critical mass to raise our voices, and we also need to understand the points for different actors.  Countries don't want to be seen in a negative light.  They want to do everything to show how good they are.  
	Canada and India are classic examples.  The minister of health was applauded by the way she dealt with COVID in the states.  She was given an award for it.  
	So we need to do this with TB as well.  Name and shame, praise people that are doing well, and those who don't do well, we really need to name and shame them.  Next slide, please.  So when we hold actors accountable, we need to push that countries, national TB programs maintain the TB testing services.  They cannot be stopped at any cost.  
	Donors.  No shifting focus from TB.  No redirecting funds.  Companies.  We have to push the fact that no profits over lives, and we're not going to keep quiet until that happens.  
	R&D.  For COVID, yes, but cannot be at the cost of TB.  TB R&D must continue and investment into TB R&D must continue.  There cannot be a compromise on quality of care.  No more window dressing.  Thank you very much.  
     >> DAVID BRANIGAN:  Thank you for your amazing presentation.  
It's so important that TB does not get crowded out by the focus on COVID and the impact of COVID on TB notifications has been really worrying. And as we're anticipating a surge in TB notifications as the lockdowns reduce, we need for testing capacity to be in place and ready to address that.  
	I want to say thank you to all of the excellent presenters for sharing all this information and suggestions for TB diagnostics advocacy, that activists can move forward in their communities and countries and at the global level and thanks to everyone that entered questions into the chat.  
	We're going to move into our question and answer segment of the webinar.  If you have additional questions, please enter them into the chat.  I'm now going to hand it over to Lynnette now, a consultant working with Treatment Action Group, to facilitate the question and answer segment of the webinar.  
     >> LYNETTE MABOTE:  Thank you very much for this presentation.  You are our mother.  You took us from zero to hero.  The fact that we have associations of TB people at national levels, a lot of us know about treatment literacy driven by people such as yourself.  I think you should be commended.  Thank you for that.  I start with you in terms of questions.  
	I think the main question that's been asked is are we facing a situation where TB is a criminalized disease?  If so, what are we supposed to do in terms of educating communities around testing?  Education that has been so far done does not seem adequate.  Do we need to ramp up and how do we ramp that up?  That was a very key question asked to you.  
     I'm going to run through all of the questions since we don't have time for all of the panelists.  So that was your first question.  Your second question and also parting thought would be now that we are at a juncture competing with COVID three months old and TB is before Christ.  
     It was around before Christ.  What is it that we need to do as a community to really have a proper paradigm shift instead of working in silos?  That is for all of the panelists.  Think about that question.  As you answer your questions from the audience, finish with that one as your parting shot.  
	I'll move on to questions that I have for Madhukar Pai.  They say there are ‑‑ there's a new trend to optimize GeneXpert utilizations.  Will they hold now that we have COVID?  That's your first question.  The second question is are we likely to see POC biomarker based tests in the market anytime soon?  
	Your third question is, you've always been a passionate advocate around diagnostics and the first Essential Diagnostics List and we have one other one for you and is this moving and being funded?  Can he we hitch a ride so every chance for COVID is followed by TB screening?  That was asked earlier.  
	For Stijn, when do we expect the LAM test high in sensitivity.  That's your first question.  Do you know how many countries in Africa adopted policies for LAM and are operationalizing those policies?  So that is your question.  
	We have another question for him, and it's also on GeneXpert, and the question is, why do we have ‑‑ why is GeneXpert punted as a true point of care diagnostic tool when it is so sensitive and does not accommodate all environmental conditions?   
	So I will hand over to my panelists.  We'll start with you.  
     >> BLESSINA KUMAR:  Thank you very much.  First the question about is TB criminalized?  The answer is yes and no in the sense that it's not as criminalized as it is disempowering.  You know if we look although criminalization and HIV it was really different.  
	Here in TB it really disempowers you.  One of the patients said to me when I walk in to see the doctor, I feel like I need to leave my self‑respect and dignity behind.  That was a really, really powerful statement.  I keep questioning myself.  What have we done to change that?  Why should TB patients feel that way?  They haven't done anything to get that other than breathing.  
	It's a question of rights.  We can't allow even a single person with a TB to feel that way, to take seven years to get a diagnosis I would say that's important.  The paradigm shift someone asked about, look at the TB response today.  You know, civil society and communities actually --  We are ‑‑ we never lead.  
	We don't set the agenda.  You know, this is the power mix that needs to be inverted.  We learned after 10, 15 years in working in HIV that it is the affected community that can lead.  Everyone else should follow.  
	If you see in TB it's actually not the community.  Community is told what to do, and we all are very happy with that.  So let's not be happy with crumbs being thrown at us.  Let's ask for the whole picture so that we make a difference.  That's the paradigm shift.  Let's make it more about people.  
	People‑centered response.  Even the UNHLM agreed to that.  What the heck does that mean, you know?  
	So I think these are some of the things that we need to really discuss and going forward I hope that ‑‑ I hope whatever is left of 2020 and 2021, we can work together to make that paradigm shift really happen.  So that people are empowered to seek care and not be afraid and feel like they did something wrong.  Thank you.  
     >> LYNETTE MABOTE:  Thank you.  Over to you Madhukar.  I apologize for throwing this question in.  It basically says insight into how far we are in having sequencing implemented in most low resource countries.  Please also address that question.  Thank you.  
     >> DR. MADHUKAR PAI:  I'll be super brief because we have other panelists to take questions.  The first question was on optimization of GeneXpert.  We all agree that GeneXpert and the disease platforms need to be optimized not underused and used for multiple diseases, which I think is critical.  So I think there is no problem with that.  I think the bigger concern we have is if GeneXpert is almost exclusively only being diverted to what's COVID‑19 and TB is dropped, then that's a problem.  
	I would rather have COVID tests done in the day and TB tests are done at night one way or another.  If you use the GeneXpert machine to its full capacity and we don't drop TB testing, then I would say it's successful optimization.  
	Which biomarker test might we have on the market soon?  I would think high sensitivity LAM test is the most feasible to go on the market soon, whether that will be delayed because of COVID‑related disruptions, I would have to probably say yes.  
	All clinical trials have come to a halt and R&D is suffering from non-COVID conditions.  Why is this so late?  It's just because nobody cared in global health for anything other than medicines and vaccines for decades.  Not even donors.  
	I think COVID‑19 is the strongest example I can think of where everybody is finally woken up and understood why we need diagnostics.  Without diagnostics, we cannot control that adequately and manage any clinical problems.  I hope this will lead to a paradigm shift in how the community views and sees diagnostics.  
	Sequencing.  A lot of progress is made.  It's still a challenge.  If you can directly do sequencing from the samples and if it's affordable and you can get the bio-informatics more meaningfully done, I think sequencing has great potential.  We are slowly heading towards that.  Whether it will happen next year or not I can't tell.  It's certainly something that looks feasible and promising.  Thank you.  
     >> LYNETTE MABOTE:  Thank you.  Stijn, over to you.  
     >> STIJN DEBORGGRAEVE:  Thank you.  So the first question was on when the more sensitive TB LAM test is more available.  I would say the sooner the better and the highest is for the Fuji LAM test developed by Fujifilm.  We feel a little bit delayed due to COVID because a lot of clinical trials have been stopped or delayed.  So I think it will take another year or two years before the evaluation data will be fully available.  You need to get the testing into the market and countries.