IAS PRESIDENT-ELECT BEKKER:  It’s my great pleasure to welcome everyone to an intimate panel, but a very, very important one, I think.  My name is Linda-Gail Bekker.  I am the president-elect of the International AIDS Society.  I come from the Desmond Tutu HIV Center in Capetown, and am delighted to have everyone at the Durban meeting of the International AIDS Conference, AIDS 2016.

And nothing is more foremost in our minds in terms of the size of the epidemic in this part of the world, and the scale of our treatment program, but also the real concern of ongoing transmission.  And in this part of the world where we are, this is particularly amongst young adolescent girls and young women.  And so thanks to our colleagues and partners, who thought that it was really important to have this high level press conference to discuss as they pertain particularly to adolescent girls and young women.

So on the panel with me are, and I’ll introduce each panel member and ask them to give some remarks.  After that, we will open the floor to questions and some interaction, and see where that goes.  So in the first instance I would like to ask the Director of the National Institute of Allergy and Infectious Diseases, Dr.  Tony Fauci, who has been working in this field, as you all know, for many, many years, and has really been at the forefront of research and development, and at the heart of many of the tools that we are using today.  So I am going to ask Tony to start first with the remarks around what are some of the innovations that, particularly, we can bring to bear in trying to curtail the ongoing transmission to young women and adolescent girls?  Dr. Fauci?

NIAID DIRECTOR FAUCI:  Thank you very much, Linda-Gail.  It’s a pleasure to be here with you today.  So as Dr. Bekker said, there is a real problem that we have globally, but particularly here in South Africa, with infections of young women.  Globally, there are about 390,000 in new infections among young women in the world, about 1,000 a day, a completely unacceptable statistic.  And so just for a minute or two, I want to bring to your attention a couple of studies, among many, that are trying to address the particular issue of prevention in women.

One of the approaches has been using a pre-exposure prophylaxis approach of a Dapivirine vaginal ring.  Some of you may be aware of the ASPIRE study, which was completed and showed some interesting, in some cases encouraging, in some cases discouraging, but all to point being provocative results.  That if you look at the entire study, about twenty-seven percent efficacy up to maybe thirty-seven percent, but when you broke it down into age group, if you were a young woman less than twenty-five, particularly if you were closer to twenty, the results of that study showed almost no efficacy.  If you were older than twenty-five it was considerably higher, well over thirty to forty percent. 

However, we have done now a sub-group analysis of the study, and showing that if you rely on people having taken the procedure of inserting and using the Dapivirine ring, the efficacy could be as high as fifty-plus, and even as high as seventy-five percent.  So because of that, we are trying to figure out what the reason for that is, vis-à-vis adherence. 

And so today, actually, we launched the HOPE study.  And what the HOPE study is going to do is, they’re going to replicate the design of the ASPIRE study, except make it so that a person does not come into the study only because they want to have the advantage of the services, because those are maybe some of the ones that you get fooled into thinking that they took the intervention, and they didn’t.  So it’s an open-labeled study that has individuals come in, even if they don’t want to participate in the actual study, themselves, they just want to avail themselves of the services.  Which takes away all of the confounding incentives and disincentives for a study.  So we are really excited about that we have launched that study.

One other thing that is important is the now data that is out on the Promise study, where it is very clear now that treatment of women, pregnant women, intrapartum, peripartum, and anti-postpartum, can essentially eliminate breastfeeding-related transmission of HIV.  So we have some important science, and as I have said when Deb and I were talking at the opening of the PEPFAR meeting, we follow the science, and that takes us to where we need to implement.  And right now, the science is quite solid that we will be able to prevent HIV infection in women. 

And one last thing I just want to bring to your attention, there is a study called a REPRIEVE study, which is looking at trying to decrease cardiovascular disease in individuals who are treated, with HIV infection, by making available to them statins to decrease the incidence of cardiovascular disease.  Women, now, are coming into that cohort.  We need to continue to bring women into that cohort.  It’s a 6,500 person study.  We have only accrued about 1,600 people, so we want to encourage individuals to enroll in that study, which we think will be very important.  I will stop there and hand it over to Deb, and would be happy to answer any questions.  Deb?

IAS PRESIDENT-ELECT BEKKER:  I will introduce Ambassador Birx as the person who leads the PEPFAR program, very important in this part of the world, and has been extraordinarily important to date, and a huge emphasis on treatment.  Ambassador Birx, today, truly making sure those numbers come up to scratch, but increasingly turning its attention to say, how can we stop the infection?  And so that’s the question, how do we implement this tool?

U.S. AMBASSADOR BIRX:  Great, thank you, and it’s really a privilege to be here with both of you.  I want to start by making a very important comment.  Over the last five years, both the South African scientists and NIH in their research that they have been doing, have been sharing information with us early.  Early, before you see it packaged in abstracts, and posters, and in presentations.  And it was on the basis of their information and the basis of the incidence of the high rate of infections in young women that we really put together the DREAMS program based on the information very much coming from NIH supported studies here in South Africa, where they really define, and you’ll see more about this presentation tomorrow, but really defining what girls are at the most risk, why are they at risk, who are they having sex with, and how do we change the future for young women?

About six years ago, Secretary Kerry, well Secretary Clinton at the time, launched what we called the Violence against Children Initiatives.  And they were surveys that we put into the field.  We started out doing one or two, we have now done eleven, and seventeen are planned, total, within the next twelve to twenty-four months.  These surveys showed us that in addition to the high incidence that we were seeing, that the level of gender based violence, where twenty-five percent of young women to thirty-five percent of young women’s first sex is sexual assault and rape.

We went on to ask those young women about, what about their sexual violence history, their lifetime experience?  These were twenty-four year old women. Their lifetime sexual violence experience approached fifty percent across every country we have studied, whether it’s Haiti, or Zimbabwe, or Zambia.  So DREAMS, determined, resilient, empowered, AIDS free, mentored, and safe young women, please come to the DREAMS booth, and please have a dialogue with young women to really understand what is putting them at risk. 

But DREAMS is really about creating a different future for young women, working across in a multi-sectorial approach, again, coming from information and studies out of southern Africa, really showing that education and retention in education is absolutely critical, decreasing incidence or prevalence of the HIV by more than thirty percent for women.

So in taking together that data, the gender based violence data, the need to really change the brand of young women in the community, we have joined with the Bill and Melinda Gates Foundation, Girl Effects, ViiV Healthcare, Johnson and Johnson, and Gilead, to work together, using the best scientific evidence, and the community relationships, and young girls’ voices, not only seeing them and hearing them, but bringing them in as part of the solution in how we are approaching that, and putting that together in a 385 million dollar package.

When we looked at it, though, we felt like there were still community efforts that were missing.  And so this week we are announcing the winners of the 85 million dollar proposal, of which fifty percent have never received PEPFAR dollars before.  We have put out 70 billion dollars, 70 billion U.S. government dollars in the last thirteen years, 55 billion of that in the last eight years under President Obama.  So it is difficult to find people who have not received PEPFAR funds, but we found local groups, small groups, small grassroots groups, youth-led often, to really engage with us in finding an innovative new solution.  Because we have to be honest, we have only decreased incidence by fifteen percent in young women.  So we have to know we have done some things right, but we have a lot more to go.

I will end with just one.  We are so always thrilled by the work that NIH does.  We took PROMISE and its insights, and we are putting another 15 million dollars to continue to follow those mother-baby pairs, to really find out what keeps women on treatment, because we have launched into B-plus.  And so PROMISE has become PROMOTE, and we really want to show that we are investing in both implementation science, and the implementation to really understand how to do programs better.

Finally, I don’t want you to think we have left young men behind.  So we have been working very closely with young men based on the CAPRISA data to increase voluntary medical male circumcision.  We have done over 10 million circumcisions in the last few years.  And we are also looking at the other end of the spectrum, twenty-five to thirty-five year old men, the least likely to test for HIV, and so none of them know their status.  And we are working with the twenty-five to thirty-five year old men to find them, get them tested, and immediately like them to ART.

And we believe that combination, prevention, multi-sectorial, all-embracing approach for young women in the community, treatment, circumcision, condoms, together, prevention and treatment linked, not dis-linked, not creating artificial separations, and bringing them together for maximum impact.  But what I am truly excited about is the sharing between scientists and implementers so that we can translate new information immediately into better quality programming.  Thank you.

IAS PRESIDENT-ELECT BEKKER:  Thank you very much to both of you.  And let me say that this is really urgent.  So from where I sit, and I am in Cape Town, not in KwaZulu-Natal.  And I think there is a notion that this is where all the infection occurs.  But actually, sub-Saharan Africa, and certainly the east and southern region, is indescribably hit.  So even in my setting in Cape Town, I see young women, incidences of eight out of every ten, every year, becoming infected with HIV.  And you know, our choices have just not been sufficient to date, or perhaps we just haven’t put those choices together in ways that have had impact. 

And so what I hear is, on the one hand, more choices being put into our hands, and I am very excited.  I am calling it the prevention revolution.  There are ideas coming through that we have to get into the field as soon as possible.  And then, we are actually being shown how to do this to the best effect for the greatest impact.  And I am looking forward to seeing this bench to field, field back to us, to say, how do we hone this to get this right so that we can really turn those statistics around? 

I think it is really important to know that once a young person becomes infected, on the one hand they have a lifetime to transmit to unborn children and to partners, so clearly that we want to prevent, but also it changes the fabric of society and how we drive our society, so it’s really critical that we begin to see those numbers go down.  Because this is the one population in which UN AIDS tells us we continue to see mortality rates rise, and so we have to do something about this sooner rather than later.

So we will now open to the room, if there are any other questions anybody wants to raise in particular, happy to answer. 

MEDIA:  My name is Lucy Bradley-Springer.  I am the editor of the Journal of the Association of Nurses in AIDS Care.  And I am convinced that the women’s epidemic is related to violence, which is related to cultural issues of putting women in a second-class position and not paying attention to their rights.  And I am wondering what is going on in that area?

U.S. AMBASSADOR BIRX:  Great, I will be real brief because I tried to touch on this just a little bit.  In the beginning of President Obama’s administration and Secretary Clinton, she had a deep concern about gender-based violence and saw it in every place where she went. And that was why the Violence against Children surveys were launched and because of those surveys, legal frameworks have changed.  But there is a vast divide between the changing of legal frameworks and changing of the community to ensure that that gender-based violence is no longer normative. 

So yes, we are working with men’s programs, and yes we are working in the community under DREAMS, but there needs to be a complete normative cultural change, as you just described, for all women in order for us to have a different outcome.

When I tell you a third of the young girls’ first sexual experience is rape, that means their mother, or their aunts, or their grandmothers, have had that same experience.  There is a level of acceptance that that is a normative experience for young women.  That is what we have to change, or we are not going to get perpetrators prosecuted, and we are not going to change this. 

Part of DREAMS is bringing in the private sector to help us with that branding change, where communities will want to be branded as a gender equality, anti-violence community, and where the brand of a young woman is applauded and valued.  And I couldn’t agree with you more, and it is these kind of normative changes that we have to see in a leapfrog way, just like what is happening in telecom.  I believe it is possible, but we have to work at it.

NIAID DIRECTOR FAUCI:  Also, I think it is important to call out leaders, community leaders and leaders of countries, to articulate very clearly and unequivocally how unacceptable this is.  Because as Deb said, if you sort of say it is part of life in a particular area, that is as wrong and evil as doing it yourself.  So accepting this as part of a societal issue is, as far as we can see, at least in the scientific community, is something that is unacceptable and needs to be aggressively spoken out against, otherwise society is not going to spontaneously change by itself.  It needs leadership.

IAS PRESIDENT-ELECT BEKKER:  And I would just add that this is where the RND has been so important.  We have needed to give young women something they could use discreetly while we fix society, which there is no doubt that needs to happen.  But in the meantime, my job is to protect those young women in whatever way I can, so we have needed prevention tools that did not depend on their partners.  And to date, that is all I have had to offer a seventeen year old is, “Can you ask your intimate partner to use a male condom?”  And even if she managed to get her hand on a female condom, she is not going to be able to do that discreetly, and that has generated some of that gender based violence, and that element of non-control.

I am running a prep study myself with young women in Cape Town, and I will quote a seventeen year old who said to me, “For the first time in my life I own my own sexuality.”  And that kind of agency is what we really want to multiply across the continent, and more.  And so we have to continue to look for other options that really will enable young women to take control of their own lives whilst we work on these much bigger issues, which there is no doubt needs to be done.  So, thank you for raising it.  Are there any other?  Yes?

MEDIA:  Thank you very much.  My name is Anna [inaudible 19:00] and I wear a lot of hats, including the fact that I am an HIV and AIDS advocate for young women.  But I am also a media person covering for this Zimbabwe Broadcasting Corporation at this conference.  Thank you so much Ambassador, and Anthony, and Linda, for what you have said, but I want to zone in on PrEP that you talked about, Linda, which is what science is telling us, that PrEP works, and PrEP should be there right now, and that’s why the WHO has been sending out guidelines. 

But I want to hear more about PrEP within DREAMS.  What is the plan and how do we get PrEP, especially in countries such as where I come from, in Zimbabwe, where PrEP is not particularly something that is available?

U.S. AMBASSADOR BIRX:  A great question.  So five countries in the first round of implementation are already starting PrEP for young women.  So that is really important for us to really demonstrate that feasibility.  Because you just heard about this question of the ability to adhere, and we believe young women will adhere when they know they are taking something effective. 

So we have launched in five countries, PrEP.  There is a whole series of new PrEP work that will come into this 85 million.  So thank you for that question.  It is part of our implementation of DREAMS.

IAS PRESIDENT-ELECT BEKKER:  And you will hear more during this conference, and I think in the next probably few months, as these demonstration and other demonstration projects start to come to fruition.  I think it’s not does it work, but how do we implement it, and I think this is where DREAMS and other programs are going to be so important for us to answer.  Any other questions? 

MEDIA:  Fred [inaudible20:45] with [inaudible] TV.  Can you describe briefly, very simply, your input, your community input experience?  The community input, how do you organize that?

U.S. AMBASSADOR BIRX:  Well, I will start really quickly, because this has been a big emphasis over the last two years.  So we have opened up all of our processes to the community, not only our data, which is completely transparent now.  It is on our website down to the district level, and you can see our performance in every single district, across every budget code.  I know that doesn't sound like much, but it is a lot.  It is over 50,000 sites within districts.  And within that we have also opened up what we call our Country Operational Plans, Discussions, and Reviews, to the point that at this last set of reviews, which was amazing, we had community, government, our multi-sectoral partners with WHO, UN AIDS, and Global Fund, all together to help us create the best program we can in each of the sixty countries that we work in.

And so, now, routine community engagement occurs two different ways.  One of them is routine working with the risk group that we are specifically focused on, whether it is key populations, sex workers, men who have sex with men, gay and bisexual men, transwomen, prisoners and migrants, working directly within those communities and to those opinion leaders and voices.  The second is with the young women, and bringing them directly to the table. 

Could we do it better?  Yes, every day we work on ways to get better, with the community input.  But not only taking input, but also investing in the community leadership for community led projects and peer-to-peer led projects, which is where we are really trying to shift resources right now. 

NIAID DIRECTOR FAUCI:  Just to add to that, I had the pleasure and the opportunity, for the better part of today, to visit a number of clinics around the Durban area, the Vulindlela Clinic and the Ethekwini Clinic.  And I was struck by the very clear and open presence of community involvement.  In fact, the first thing I did when I walked into the clinic was being introduced to the community leader, the CAB leader, and very much involved in the study.  And the participants in the study related their relationship to the community as one of the important reasons why they were involved in the study.  It was really quite striking.  I didn’t expect to see that right from the beginning.

IAS PRESIDENT-ELECT BEKKER:  So I am part of the NIH network environment in this country, certainly, and this is playing such an important role in terms of the human research, the clinical research.  And it is a requirement that we not only on paper show that we have community engagement, but that it actually is actively happening.  And I believe that every clinical trial site that is linked to many of the studies you have heard described here have a very core part of their work is community engagement, making sure community is involved right from the point of protocol inception and protocol design, all the way through to results, dissemination, and then finally actually getting the product into the field again.  So I am happy to discuss that in more detail as to how it happens on the ground.  I am very proud of it, and South Africa making a significant contribution, and this region, to that work.  I am very grateful to the National Institute of Health for providing a lot of the funding.

U.S. AMBASSADOR BIRX:  And let me just apologize.  The reason we started a little late is because I was over with the march, so that’s why I ran over here.  Because I think it is not just a matter of words, it is actual physical engagement and direct funding, and putting our words into action, and showing that we trust community led programming and services, and to really honor that.

MEDIA:  Hi, my name is Catherine.  I am from the Times Newspaper in South Africa.  And just for clarity for Ambassador Birx, you said you are starting PrEP in five countries.  Does that include South Africa, among young women?  And then you said there was violence, about a quarter of women had experienced sexual violence.  Does that also include South Africa in that study?

U.S. AMBASSADOR BIRX:  That study has not been done in South Africa.  It has been done now in eleven other countries, but in countries, certainly, that rim South Africa.  We have not found a country yet, anywhere in Africa or Haiti, where the violence was less than twenty-three percent as for sex being sexual assault, and nothing less than about thirty-nine percent for lifetime experience of twenty-four year olds with sexual violence.  And I think we have to remember that this is a common phenomenon, where I think it has also been raised in the United States by President Obama and the First Lady, that one in five young women in their four years’ experience at college in the United States are being sexually assaulted.  So this is a shared problem globally, where it needs to be addressed.

PrEP has started in South Africa as part of a sex worker program.  It is not across the board in adolescents as part of DREAMS yet, but we do have countries that are doing that.

IAS PRESIDENT-ELECT BEKKER:  Perhaps I can just add that Rachel Dukes and other researchers have found very similar numbers in South Africa, so gender based violence is rife globally, I think.  And then just to say, I think government is seriously thinking young women and adolescent girls, but the sex worker program is the one that has been launched.  And you will be hearing more about it tomorrow.  There is a press conference on PrEP tomorrow. 

Well I think that it has been really great to hear from, I think, two very important players.  We are hopeful that we will begin to see those numbers begin to turn down in the next five years.  And I look forward to the rest of conference.  We will see more of that detail and I hope you will be watching again tomorrow afternoon, there will be some excellent data presented, and throughout the conference.  I look forward to seeing that and the rollout of some of the innovation in the DREAMS program and other programs that are about to embark.

I think both of you are available if there are specific interviews or questions that might want to be raised personally.  Otherwise, have a good conference, and I will see you soon.