Sustainable HIV prevention possibilities present choices, challenges

via Science Speaks, by Antigone Barton

When he looks at what biomedical science can do in the next decade to prevent HIV transmission, Jim Turpin of the National Institutes of Health said, he thinks of the lyrics of a Timbuk3 song: “The future’s so bright I gotta wear shades.”

By, which, actually, he means — don’t get blinded by the light; the search for answers will require focus.
“The challenge is not the lack of options,” he said, “but prioritizing the best options.”

Turpin, program officer and branch chief in the Prevention Sciences Program in the Division of AIDS at NIH”s  National Institute of Allergy and Infection Disease spoke this morning in webinar titled “The HIV Prevention Pipeline: A Future of Possibilities.” The webinar was sponsored by the International Rectal Microbicide Advocates (IRMA) and AVAC Global Advocacy for HIV Prevention.

After a series of disappointments in the quest for a vaccine or microbicide to prevent HIV transmission, the last two years offered hope, in strategies using antiretroviral medicine to prevent acquiring HIV, organizers point out. But, with a diversity of prevention needs and challenges among women and men worldwide still demanding answers, is that all there is?

Or, as Turpin put it, “Do we currently have what it takes to create a sustainable prevention pipeline?”

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

ARM-ing Africa for Rectal Microbicides

Original content from the Mapping Pathways blog team

These are exciting times in the HIV-prevention landscape.  In an earlier Mapping Pathways post, we covered our colleague, Jim Pickett’s experiences at the Microbicides 2012 (M2012) conference in Sydney in April.  At M2012, advocates discussed a number of important issues, including the importance of adherence in clinical trials. 

A major development at M2012 was a report released by the International Rectal Microbicide Advocates (IRMA), a global network that Jim leads, as a cornerstone of their Project ARM (Africa for Rectal Microbicides). The report, titled “On the Map: Ensuring Africa’s place in Rectal Microbicide Research and Advocacy” outlines priority actions to ensure Africa is involved in rectal microbicide research and advocacy activities.

On The Map is the result of a two-day consultation that took place before the ICASA conference in Addis Ababa in December with African and international stakeholders. Says Pickett, “The central question of the consultation was ‘How can we be more strategic and proactive to make sure Africa is on the map when it comes to rectal microbicide research and advocacy?’”

The Project ARM report lays out seven key action areas specific to rectal microbicide research and advocacy in the African context:

Knowledge, Attitudes and Behaviors (KAB) studies on anal health and anal sex to generate data that can be analyzed across countries and populations

Rectal microbicide acceptability studies

Mapping of sex education curricula to determine what content on anal health is included

Advocacy for lubricant access through the “And Lube” campaign of the Global Lube Advocacy Mobilisation (GLAM)

Documentation of best practices for integrating anal health, anal intercourse and rectal microbicides into sexual health and HIV prevention education

Capacity-building activities for community leaders, advocates, and researchers

Awareness raising and education about anal health, anal intercourse, and rectal microbicides, including development of educational materials and other communications efforts specific to the African context

According to Pickett, members of the Project ARM working group further prioritized the key activities. While the members agreed that all the activities are important, the top three are the KAB studies, awareness raising and education on anal health and anal intercourse, and improving access to condom-compatible lubricants, which are in very short supply across most of Africa.

Pickett explained that the HIV epidemic in Africa is often wrongly considered as solely heterosexual, with sexual transmission driven entirely by unprotected vaginal sex between men and women. “There has been little to no official recognition of the fact that there are gay men and other men who have sex with men in Africa who are enduring high rates of HIV, and that plenty of heterosexuals also have anal sex. Unprotected anal intercourse is 10 to 20 times more likely to result in an HIV infection compared to unprotected vaginal intercourse,” says Pickett.

As mentioned, increasing access to condom-compatible lubricant is a key goal of Project ARM. Access to appropriate lubricants on the continent is quite abysmal. “In the absence of appropriate, safe lubricants, people use things like shampoo, cooking oil, hand lotion, antibiotic creams – even motor oil – that break down the latex in the condom, erasing the protective benefits.. People also use saliva, which dries out quickly – and can cause tears in the condom as well as harm the fragile rectal environment. For safer anal sex, lubrication that is condom-compatible is absolutely necessary,” says Pickett.

 “There is an immediate need for appropriate lubricants for people who have anal intercourse in Africa. If we can’t get lubricant to people now, how will we be able to deliver rectal microbicides to them when they become available? Increasing access to appropriate lube is absolutely critical, and paves the way for access to rectal microbicides down the line. We can’t have campaigns and programs that deliver condoms without also delivering condom-compatible lubes. Period.”

Stay tuned to the blog as we bring you more information on this exciting project. Until then, read a vivid snapshot of advocacy in Africa through the eyes of Brian Kanyemba here. Brian has been very involved with IRMA's Project ARM, and is an integral member of the Project ARM video working group, which is trying to produce an African-focused video on anal health and anal intercourse.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

Microbicides 2012 Conference: “Someday, our ARV-prevention tools will be as sexy as the I-Phone!”

Original content from the Mapping Pathways blog team

This is the second part of a two-part blog series on highlights and discussions from the Microbicides 2012 conference that recently concluded in Sydney. Here, Jim Pickett re-emphasizes the importance of adherence in clinical trials (a big topic of discussion at the conference) and his optimism about the future of the HIV prevention and treatment landscape. Read Part I here.

MP: Can you give us some examples that illustrate the issues surrounding adherence?

JP: The Partners PrEP trial and the FEM-PrEP trial are good case studies to illustrate the issues surrounding adherence in an HIV prevention clinical trial. Partners PrEP reported very high levels of adherence while the FEM-PrEP trial had to be stopped in April 2011 due to “futility.” Studies later indicated that while many of the FEM-PrEP participants said they adhered to the medication schedule, blood tests indicated that many did not.

A built-in support system and the risk perception of participants are the key here. In Partners PrEP, serodiscordant couples were enrolled together into the trial. One partner was HIV positive while the other was negative. The HIV risk of the HIV-negative partner was not theoretical; it was real. HIV was in their life and they were in it together.

FEM-PrEP involved women recruited on their own, with no consideration whether they were in a serodiscordant relationship – or any relationship for that matter. The risk of HIV was not present in the form of a partner who already had it, but it was, in fact, present in their environment where there was very high HIV incidenceIV HIV . It is interesting that many of these women did not believe themselves to be at a high risk of HIV, despite this high incidence.

Human beings are very good at rationalizing risks and saying “it can never happen to us.” I can drive fast and will never get into a car accident. If I feel a certain behavior is not risky, or that I can “get away with it”, I will not take steps to protect myself.

We don’t want to create tools where only people who are married or in a relationship are able to use the tools successfully. That would be crazy. But we do have to think about how important those social relationships are and use the lessons learned to devise new tools and new trials that give us answers – and develop things that work for all kinds of people, regardless of relationship status, sexual orientation, or whether their potential HIV exposure comes from unprotected vaginal intercourse, unprotected anal intercourse, or from the sharing of syringes during injection drug use.

MP: Are there any trials coming up that you are excited about?

JP: I’m very excited by the upcoming MTN-017 rectal microbicide safety and acceptability trial that will enroll approximately 186 gay men, other men who have sex with men, and transgender women at trial sites in South Africa, Peru, Thailand, and the United States. Participants will go through three eight-week cycles: One cycle of having a daily Truvada tablet, another cycle of applying a “rectal friendly” reformulated tenofovir gel every day, and a cycle of applying the gel before and after having sex.

What impresses me is the level of community involvement sought and obtained to help design this trial. The trial team, and advocates such as myself, visited each of the sites mentioned, had day-long meetings with community members, captured all their observations, and made adjustments to the trial design from the input received. We have to listen to the voices of the communities. We can’t just show up and conduct trials.

MP: What are your other thoughts on the HIV prevention and treatment landscape?

JP: I always like to compare the HIV prevention and treatment landscape to the evolution of computers and phones. Years ago, computers were the size of a house. It took time for the computer to evolve from its clunky beginnings to its current look where we can carry it around in our pocket and it can do more things than we ever could have imagined. Now we have phones and computers that are completely intuitive and easy to use.

Similarly, the HIV landscape has evolved over the years. Before 1996, we had a handful of drugs that didn’t always work great. They were toxic and had to be taken multiple times a day. When protease inhibitors came out in 1996, people near death’s door were brought back to life. But they also had to suffer through a whole host of side effects like nausea, diarrhea, and body disfigurements.

Now, new-age ARV medication can combine three drugs into one pill that has to be taken just once a day. The side effects are minimal and you don’t have to worry about requirements like eating it on a full or empty stomach, or having it refrigerated.

We are now in the clunky computer stage of ARV-based prevention. But, things will keep getting better. We can’t get to the streamlined phase before going through the clunky phase. We have to learn to crawl before we can run. Someday, our ARV prevention tools will be as sexy as the iPhone.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Read Part I of Jim’s interview here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Microbicides 2012 Conference: Adherence – the A-word on everyone’s lips

Original content from the Mapping Pathways blog team

In part I of this two-part blog series, Jim Pickett talks about his experiences at the recently concluded Microbicides 2012 conference in Sydney and the buzz among advocates and trial designers today.

MP: What were some of the highlights for you from the conference?

JP: The conference in itself was great with many interesting and informative presentations. A highlight for me was that conversations about rectal microbicides were integrated throughout the conference and not just in one or two presentations. Rectal microbicides got a lot of attention.

From a Mapping Pathways perspective, we submitted an oral abstract that was accepted and I think the presentation I did was well received. We generated a lot of conversations about the work we have been doing and are planning to do in the upcoming year.

A Canadian colleague presented on their country’s plans for integrating ARV-based prevention into their national prevention plan and one of their planned activities is to develop a Canadian version of Mapping Pathways. This stems from a consultation in Ottawa I participated in last year – so it was gratifying to see Mapping Pathways being picked up by others – and presented at an international conference.

MP: Are there any major themes that emerged from this conference?

JP: Adherence, the A-word, was a very big topic throughout the entire conference. We realized that we have to make HIV-prevention or treatment products people like and will want to adhere to. We have to figure out how tools like PrEP and microbicides fit in people’s lives, and funding should be put in place to better understand what people want, how they have sex, and the role of pleasure, love and intimacy, among many other “real world” realities. Right now, only about two percent of the budget of any study is used for the socio-behavioral aspect – that is, understanding participants’ motivations, documenting adherence, and exploring the communities they are a part of.

Adherence is especially crucial for PrEP to move into the real world. Participants in trials come to the clinic for monthly visits that include a host of prevention services and counseling on condom use and adherence to the study product. If adherence is an issue in such a controlled environment, how big of an issue will it be in the real world where they are not getting that level of intensive support?

A scenario where a trial has to be stopped because people did not take the drug is a major concern because it leaves us more questions than answers. We get no answers on the efficacy of the drug – we are left thinking “what if the person had taken it as instructed?”  We cannot afford to spend millions on trial after trial where we find out finally that people did not take the drug as instructed.

Sure, the lack of adherence could be telling us about acceptability – and if we are making products that people are having a hard time adhering to, is this product really acceptable? By the same token, this is an iterative process – what we have is what we have right now, and the only way to determine if the drug works is if people take it. We can’t improve on the delivery if we can’t answer that question. It is a bit of a conundrum.

MP: What are some of the strategies discussed to tackle the issue of low adherence?

JP: The first step, as mentioned, is to increase funding for the socio-behavioral components of the trial. We need to do better at finding the “right” trial participants. Imagine a case where two people are being recruited for an HIV study trial. One is a person who wants to do the study to the best of his or her abilities and is motivated by the aims of the study. The other person is motivated by the access to healthcare and the little monetary incentive provided by participation in the study. Would both their levels of adherence be the same? This isn’t to cast judgment on anyone – but really, we need to answer the study question – and we can’t do that if people don’t follow the study protocol.

Another interesting strategy being discussed more and more is separating the people who counsel the participants during the trial (adherence counseling) from the people who record user experiences taking, or not taking, the study product. If the same person performs these two functions, participants who form a bond with their adherence counselors during the course of the trial may be unwilling to disclose exactly how well they adhered to the program. The end goal is to find better ways to capture the data and make participants feel completely relaxed about being honest about their user experience. If they did not take the drugs as instructed, that’s ok. But we want to know why.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. Stay tuned for part II of the blog.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Keep up the fight for microbicides

via AllAfrica.com, by Julie Frederikse

Africans tracking the worldwide HIV epidemic have not found much to celebrate since Aids began ravaging the continent 30 years ago, but researchers are optimistic that they are learning as much from their failures as their successes.

Sub-Saharan Africa still carries the biggest burden of HIV worldwide, and while there has been a significant improvement in access to antiretroviral treatment in recent years, scientists searching for a gel or vaccine that can prevent HIV infection ride a rollercoaster of hope and disappointment.

Take the case of a husband and wife team from the University of KwaZulu-Natal in South Africa. Professors Salim Karim and Quarraisha Abdool Karim head up a research unit that has been at the forefront of clinical trials to find a safe and effective microbicide to protect women from HIV.

In July 2010, delegates at the last World Aids conference gave the couple a standing ovation when they announced the results of one of the most promising studies on HIV prevention to date. Their team at the Centre for the Aids Program of Research in South Africa (Caprisa), showed that a vaginal gel called tenofovir was able to reduce sexual transmission of the virus by 39 percent overall and 54 percent in women who used it consistently.

But the euphoria over this breakthrough has dissolved into disappointment, with the unexpected finding of a wider sub-Saharan African study that the microbicidal gel, when prescribed daily, does not prevent HIV infections. This has led to the suspension of tenofovir in the Vaginal and Oral Interventions to Control the Epidemic (Voice) trial.

Tenofovir is an antiretroviral drug that is taken successfully by many people living with Aids to suppress the virus. The hope had been that tenofovir could also be used to prevent HIV infection. Women are twice as likely as their male partners to acquire HIV during sex and account for 60 percent of adult HIV infections in sub-Saharan Africa. An effective microbicide would give women the option of applying the vaginal gel themselves before sex, without necessarily informing their partners.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

The year ahead: Q&A with Jim Pickett

Original content from the Mapping Pathways team

MP: In terms of studies and projects, what are you most looking forward to this year?

JP: It’s going to be an eventful year in the HIV prevention world – I’m excited, energized, and daunted, all at the same time! I’m looking forward to just following the science and seeing where that takes us. For instance, rectal microbicide trials are taking an international leap and moving up into phase 2, which is HUGE.

The other big aspect we all need to focus on this year is getting into the implementation particulars around PrEP. There is a PrEP implementation project starting in the US – about 500 gay men split between San Francisco and Miami who will be given PrEP. This is an actual implementation project, NOT a research study, and we hope to learn a great deal from it. There are critical questions around delivering the intervention: How do you get the pill to people? How do you help make sure they’re adherent? How do you keep them in the loop for ongoing testing, so you know soon if they seroconvert? We don’t know the answers because we’ve never done it! It will be very interesting and informative to see how that plays out…what comes up, what works, what’s a problem, and what needs to be changed.

There are also studies (some are happening and some are scheduled to begin in 2012) looking at different ways of dosing PrEP. Right now, we have proof that PrEP used every day works. But what about intermittent dosing – a few times a week or just around the time of sex? What about those strategies? We won’t have hard data in this year but we’ll start learning more. If we can, in fact, do intermittent dosing, or dosing just around the time of sex, that could be great – it would reduce costs, and importantly, make it easier for people to adhere. We may also find out that intermittent dosing, or dosing around the time of sex, doesn’t work. Whatever we find out will be critical to assess as we move forward with PrEP as an HIV prevention strategy.

MP: What are your thoughts on the upcoming US presidential election?

JP: I’m daunted by the 2012 American elections. Whatever happens will be critical for the entire world in terms of how we move forward with the provision of services, science, and research. American elections are always important for everybody, with far-reaching implications – and this time, the stakes are really high. It’s a critical year. But I guess you could say that about every election. When wouldn’t we say it’s critical?

MP: What about the global political landscape?

JP: If you look at politics globally, with economic crises rolling across much of the world, how governments support this work or not will be really important. We don’t want to lose ground. UNAIDS put out a report in November – an annual global snapshot – that shows that 50% of people who need treatment are now on treatment. That’s a big jump up, a good number. We’re going in the right direction and we’ve been able to achieve that even in tough times. But you’re only as good as you are today and we don’t want to lose that ground – we want to move to a place where everyone who needs treatment has it, not just half. Half is better than where we were, but we need to move forward.

We all need to keep a close eye on global politics and how that affects priorities in terms of both provision of treatment for people with HIV and ongoing work in prevention. We can’t treat ourselves out of this. We have to have a solid mix of prevention and treatment and care. Our approach needs to be holistic; if we start throwing things to the side and looking at one or two “magical” solutions, we’re going to be in trouble. When you have new things, there’s a desire to say that the old things don’t work, let’s just look at the new things and throw everything else out. Also, in times of economic scarcity, there is a tendency to pare down. We have to be smarter, use our money more strategically. Does everything work equally well? No. Can we get rid of some things? Probably, yes. But that requires a lot of thought and analysis, and every decision needs to be localized.

I think that’s what this year is going to be characterized around...how we start to make sense – and use – of all this science we’re amassing. We’re getting more and more into the rubber-hits-the-road phase.

MP: In terms of conferences in 2012, what are the highlights for you?

JP: The 2012 International Microbicides Conference will take place in Sydney in April. And the granddaddy of all conferences, the International AIDS Conference, is being held in Washington, DC in July. It’s the first time it’s been in the US for a couple of decades because we had a ban on people with HIV traveling here, which precluded us from being able to host that conference. The ban was recently lifted by the Obama administration. This conference is going to be a big deal. It’ll put the spotlight on DC, in terms of DC’s support for HIV/AIDS both domestically and internationally. It’ll also be another great opportunity for Mapping Pathways to disseminate information and we’re hoping we’ll be able to utilize that huge stage – the biggest AIDS stage there is.

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Microbicides 2012 Registration is Open!

"To share in the latest developments in HIV prevention through microbicides and other technologies, this is the conference to attend. The conference is the key event in the microbicides world, where cutting edge research will be presented by world experts, and you will have a chance to interact with people involved at every level of microbicides development "-Professor John Kaldor, The Kirby Institute and Conference co-Chair

Come to Sydney in April for the 2012 International Microbicides Conference - 'From Discovery to Delivery', with state of the art plenary lectures on microbicides and other aspects of HIV prevention research, cross-disciplinary symposia, oral abstracts, and poster sessions.

M2012 will be a global forum for the presentation and discussion of the latest information on microbicides and oral pre-exposure prophylaxis for HIV prevention and their interface with other prevention strategies. There will be a strong emphasis on the role of community in both research and implementation of scientific findings. The conference is interdisciplinary, and will include basic science, pharmacokinetics, formulation and delivery, clinical research, public health, prevention science, and social and behavioural research.

Why Should You Come?

1. LEARN... From experts from around the world who will speak on key issues in HIV prevention technologies.
2. NETWORK... with a cross-disciplinary group of researchers, community representatives and policy makers, to support you in applying new approaches and perspectives in your work.
3. PARTICIPATE... in sessions that will range from state of the art lectures, to debates on hot topics in microbicides development.

Learn more here!


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Rectal Microbicides & Africa: A Leap Forward

Original content from our Mapping Pathways blog team

Rectal microbicide advocacy has taken a huge leap forward this year, particularly in Africa. An excellent example of this progress is the International Rectal Microbicide Advocates (IRMA)-hosted Project ARM – Africa for Rectal Microbicides  meeting underway now  in Addis Ababa, Ethiopia in advance of the ICASA 2011 conference. “I am so proud of the fact that we’re at a point where we can hold a two-day strategy meeting in Africa, focusing on rectal microbicides research and advocacy in Africa. That’s just huge. A few years ago this would have been impossible – people would have laughed at you for suggesting it,” says Jim Pickett, chair of IRMA, a Director at the AIDS Foundation of Chicago, and member of the Mapping Pathways team.

The rectal microbicides field itself is also expanding, as researchers continue to push boundaries. Until now, there have only been small-scale Phase I trials for rectal microbicides. This year the first Phase II trial was announced – an expanded safety study that will begin in 2012. “The trial will involve 200 individuals, which is almost double the total number of human beings who’ve been in rectal microbicides trials so far,” Jim points out. The study is going to be multinational, taking the research outside the US to countries like Thailand, Peru, and even South Africa.

“Not too long ago, saying rectal microbicides clinical research and Africa in the same sentence would have gotten a huge eye-roll. Now it’s real, it’s happening,” says Jim. “I think that says a lot about how advocacy and science together have elevated the field, creating a great deal of understanding and support for it.”

Stay tuned to the Mapping Pathways blog for news and updates from the IRMA meeting and ICASA conference in Addis Ababa.

Please note: Registration for the AIDS 2012 conference in Washington, D.C. opened yesterday. Get the details here.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Secretary Hillary Clinton on Creating an AIDS-Free Generation: Bouquets and Brickbats

* Original content from our Mapping Pathways blog team

“An AIDS-free generation would be one of the greatest gifts we could give to the future.Let's make it happen.”

On November 9, US Secretary of State Hillary Clinton delivered a speech on HIV/AIDS at the National Institutes of Health in Bethesda, Maryland – a speech that has triggered mixed reactions from people in the HIV/AIDS treatment and prevention field. Take a look at some excerpts:

“Today we are making major investments in the search for a vaccine; for tools like microbicides, which give women the power to protect themselves; and other lifesaving innovations.”

“… our efforts have helped set the stage for the historic opportunity the world has today: to change the course of this pandemic and usher in an AIDS-free generation.”

“… creating an AIDS-free generation has never been a policy priority for the United States Government until today, because this goal would have been unimaginable just a few years ago … It requires all of us to put a variety of scientifically proven prevention tools to work in concert with each other.”

“America's combination-prevention strategy focuses on a set of interventions that have been proven most effective: ending mother-to-child transmission, expanding voluntary medical male circumcision, and scaling up treatment for people living with HIV/AIDS.”

“… we now know that if you treat a person living with HIV effectively, you reduce the risk of transmission to a partner by 96 percent.”

“Treating HIV-positive people before they become ill also has indirect economic benefits.It allows them to work, support their families, and contribute to their communities; and it averts social costs, such as caring for orphans whose parents die of AIDS-related illnesses … In other words, treating people will not only save lives – it will generate considerable economic returns too.”

“… we need to let science guide our efforts. Success depends on deploying our tools based on the best available evidence.”

“An AIDS-free generation would be one of the greatest gifts we could give to the future. Let's make it happen.”

A number of HIV/AIDS activists have applauded Clinton’s “bold” speech, pointing out her emphasis on the prioritization of the fight against the epidemic, her focus on scientific evidence, and her call for immediate action to take advantage of the “historic opportunity” to create an “AIDS-free generation.” Many hope that this kind of public statement will help boost activism to preserve domestic and international funding.

On the other hand, while Clinton mentioned vaginal microbicides for women, she failed to talk about pre-exposure prophylaxis (PrEP) and rectal microbicides. These two prevention strategies are meant to protect uninfected people from the HIV virus – they have been the subject of numerous recent trials, with substantial success being demonstrated in many of them. (Take a look at our blog post on some of these studies.) Some feel Clinton’s decision give these new prevention technologies a miss can be attributed to political, financial, and social reasons.

“The omissions were disappointing but not surprising,” says Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of International Rectal Microbicide Advocates (IRMA), and a member of the Mapping Pathways team. “Her audience was international, which means predominately heterosexual, so I suppose it made strategic sense that she would steer clear of PrEP, which has been shown to be effective for gay/bisexual men but has produced conflicting results for heterosexuals. Nonetheless, with gay men and other men who have sex with men experiencing catastrophic rates of HIV the world over, it remains disturbing to me that this group was not even mentioned, whether in conjunction with PrEP or not.”

Another possible reason for the omission of PrEP is the fact that the global jury is still out on the feasibility of rolling out PrEP interventions while there are HIV-infected people who do not have access to treatment – a problem made all the more complex because of the crippling HIV/AIDS funding constraints over the last few years. However, Pickett firmly believes that the either/or stance taken by those nixing promising preventive technologies is dangerous and close-minded. “We’re continually working to get enough information and data to answer the big questions we’re grappling with – questions about efficacy, accessibility, funding, prioritization, and acceptability. These questions are extremely challenging, but it’s imperative that we work on solving them,” says Jim. “It’s not an option to stick our head in the sand. To turn the dream of an AIDS-free generation into a reality, it is absolutely clear that we must expand access to effective ARV drugs for all those who need them – whether they are HIV-positive or HIV-negative.”

To know more about Secretary Clinton’s speech and the responses to it, read the AIDS Foundation of Chicago’s story and Science Magazine’s article. You could also check out this letter to Secretary Clinton – a blog post written by an IRMA member.

You can read the entire speech here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

First Official Mapping Pathways Presentation a Success: Canada keen to adapt project

“It’s not about telling people to go down any one pathway; it’s about providing an array of pathways that are illuminated with a little more analysis with which to shape informed policies and programs.”

Earlier this year, Jim Pickett of the AIDS Foundation of Chicago, a Mapping Pathways partner organization, was asked how he and his colleagues would measure success for this initiative. His response was prompt, explaining that the project would be successful if the knowledge and wisdom it brings together is able to provide tools that are usable for the various stakeholders. “So, for example, if here in Chicago I can take these findings to the Chicago Department of Public Health and it can help inform their community planning process around the prioritization of prevention and care dollars. Or, in India you could take the results of our outputs to the Minister of Health in Delhi and say, ‘Here is something to help us help you think about and plan how you’re going to allocate resources or roll out potential programs…or not.’ Maybe a jurisdiction will decide it will not focus on PrEP, and instead will focus on getting more people tested and treated and on doing a better job on getting people condoms. Basically, we want to help create a package of tools that people can then use to actually influence policy and do good programming in their particular context. At the end of the day, and this is the big picture, we want to avert HIV infections. We want less people to become infected and we want more people who are infected to be linked to appropriate care and treatment. And if our project can, in some small way, help create policies and programs that prevent more infections and get more people into care and treatments that are sustainable and appropriate, then I think we are successful.” (Read more of Jim’s wonderful conversation at the Mapping Pathways blog post “Success! Now What?”)

Recently, at a national stakeholder consultation in Ottawa Canada (see footnote), part of this vision for the Mapping Pathways project came true. Pickett was invited to introduce the project and share some preliminary data to a group of 30-40 key stakeholders from the Canadian government, AIDS service organizations, and others interested in new prevention technologies. This was the first official Mapping Pathways presentation since the project began earlier this year. The consultation was designed to get Canada to think how the country will deal with and incorporate the increasing number of prevention tools and strategies that are already available or will become available soon – PrEP, TLC+, and microbicides (read more about these strategies here and the various prevention trials here).

 “Canada has been following new prevention technologies for a long time,” said Pickett. “So now they are watching the science (and what at incredible year of science it’s been!), and there are things that are actionable; expanding treatment is actionable now. PrEP could be considered actionable now. So at this consultation, these folks were asking, ‘What should we do?’, ‘How do we figure this out?’, ‘What tools will we need?’, ‘How is it going to look?’, ‘How do national bodies fit into this strategy?’”

“Just asking these questions is so challenging,” said Pickett. “And Mapping Pathways is in no way saying any country should do something or not. We’re just asking questions, looking at the data, and then presenting what we find in a useful and usable way.” As Pickett put it at the beginning of this project, “It’s not about telling people to go down any one pathway; it’s about providing an array of pathways that are illuminated with a little more analysis with which to shape informed policies and programs.”

While data from the Mapping Pathways project is still being collected and synthesized, Pickett was able to present snapshots from South Africa, the US, and India; including interesting quotes from stakeholders; and general, country-specific perceptions and trends emerging from the surveys and in-depth stakeholder interviews. 

Much to Pickett’s delight, the presentation was enthusiastically received, with the Canadian stakeholders keen to go ahead and create a Canadian version of the Mapping Pathways project. “We haven’t even synthesized the data completely as yet and people are already interested in it and how they can make the project their own!”

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team.

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[1]  Canada Institute of Health Research Meeting, September 16, 2011

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

2012 International Microbicides Conference (M2012) in Sydney, Australia

The next International Microbicides Conference will be held in Sydney, Australia from April 15-18th, 2012!

Registration
Registration is not yet open, but to submit an expression of interest, please click here. By submitting this, you will be contacted as soon as official registration opens!

Abstract Submission
The 2012 International Microbicides Conference (M2012) invites papers of high quality in the areas of HIV prevention, with a particular focus on microbicides, oral chemoprophylaxis, and their interface with other prevention strategies. The conference is interdisciplinary, and encourages the full involvement of communities and individuals affected by HIV. Abstract submissions will be reviewed by the Scientific Program Committee for content, presentation, timeliness, and current interest of the topic to M2012 participants. Abstracts are welcomed from researchers, program implementers, policy makers, advocates, and community members, and will be considered for inclusion provided they meet the guidelines below.

Please click here to view the abstract submission guidelines.  Authors should submit abstracts no later than 5pm AEST time on Thursday 17 November 2011. Click here for more information and details about uploading your abstract.

Scholarships
Scholarships are available to attend the 2012 International Microbicides Conference (M2012) in Sydney, Australia.

Scholarships will be offered in four categories that have distinct criteria:
1. Research
2. Community
3. Government Official/Public Health Policy
4. Media (Further details to come - Media scholarships will open 23 September)

Scholarship applications are due 5:00 pm AEST on Thursday 17 November 2011.  Click here for more details about scholarships and to apply.

For any other information about M2012 please go to microbicides2012.org.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Safe-Sex Education: Too little, too much?

Though still in the clinical-trial phase of research, an increasing number of studies are pointing to the effectiveness of microbocides and PrEP as possible tools for promoting safe sex (See the Mapping Pathways blog post on the various trials here). These, along with more traditional prevention methods, can possibly be used as additional tools for preventing HIV infection during sexual intercourse. As a result, a question of increasing importance as we go forward is: How will we reach people and educate them about the multitude of safe-sex tools at their disposal in an informative and engaging way?

Dr. Linda-Gail Bekker from the Desmond Tutu HIV Foundation, a Mapping Pathways partner organization, puts it best: “How do you reach hard-to-reach populations? We are going to have to come up with really targeted and specific interventions.” Dr. Bekker feels that in today’s HIV/AIDS landscape, a blanket strategy no longer works for effectively educating people on various prevention strategies. “I think there is a real awakening that we need to tackle this in a slightly more strategic way. It also requires us to be innovative… Clearly if people abstained from sex, or had sex with partners they knew to be uninfected, or used condoms 100% of the time, we wouldn’t have the HIV epidemic. But obviously, spreading billboards all over the world has not cut it. I mean telling a commercial sex worker to abstain is patently daft... Specific populations need targeted input; we have to know our community and provide each risk group with nuanced messages that are relevant to them. Young girls need a certain kind of messaging compared to older women; older men require different messaging compared to younger men; circumcised men need specific messaging compared to uncircumcised men – and so on.”

Dr. Bekker makes a good point. Take, for instance, a large billboard promoting safe sex for World AIDS Day that was seen at a crowded mall in Mumbai (see below). The poster features a lady wearing a demure, white salwar kameez (a traditional Indian dress for women), with a bowl of tossed salad in her hand. The tag reads, “Say no to multiple partners... Be a responsible person.” All in all, the billboard seems more appropriate for promoting healthy eating, than healthy sexual behavior!


At the other extreme is a music video that was meant to raise awareness of safe sex and contraception methods to prevent teen pregnancies in “a fun way”. Created by Marie Stopes International and featuring a comedy music band called “The Midnight Beast,” the song’s lyrics advise teens that: “But something to remember as a rule of thumb, one up the bum and it's no harm done… one up the bum and you won't be a mum.” As one viewer commented, “I take it this video is for a world without AIDS?” Added a stunned HIV/AIDS advocate: “Teaching young people there is ‘no harm done’ during anal intercourse is an inaccurate statement... The risk of transmitting HIV during unprotected anal intercourse is significantly greater than for vaginal intercourse for a number of biological reasons.” You can read more about this controversy and see the music video (which has been watched more than 90,000 times on YouTube) here.

These examples illustrate some of the challenges in promoting safe sex, especially as we go forward in a dramatically changing prevention landscape. That said, there are currently many individuals doing inspiring work. Read about Anne Philpot’s Pleasure Project in India and the UK, which aims to bring the “sexy back to safe sex”; and about Brian Kanyemba’s travels through South Africa, where he educates people about rectal microbocides through a game called “Mapping the Body.” Also be sure to visit “My PrEP Experience, ” a new series on the gay men’s health blog LifeLube that features personal stories and first-hand accounts of people’s experiences with PrEP.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

What Happens When the "Placebo Window" Closes?

With the increasing number of trials pointing to the efficacy of PrEP and microbocides as methods of possibly preventing the risk of HIV infection, the ethics of using placebos in these trials is becoming a topic of discussion among the prevention community. We spoke with Joseph Romano, who has been involved with HIV/AIDS research and development for 20 years, about his thoughts on placebo-controlled trials, the “placebo window,” and what happens in a post-placebo era.

MP: Why do we have placebo-controlled trials?

Joseph Romano: Placebo controlled trials are essential for the evaluation of the safety and efficacy of new products.  The placebo control group in a clinical trial provides the means of establishing any specific safety issues with a product, as well as the effectiveness of the product at preventing HIV transmission.  In terms of determining efficacy in microbicide studies, or in studies of other HIV prevention products, the trials are set up so that one group receives the treatment product and the other group uses the placebo product.  The number of participants in each group that is necessary to establish the effectiveness of a product with a high degree of certainty can be calculated, and this establishes the size of the trial population.  At the end of the study, the number of seroconversions in each group is established and a mathematical comparison between the two groups is conducted.  If the number of new infections in the treatment group is lower than the number in the placebo group such that a predetermined statistical threshold is met, the drug can be defined as effective with a certain level of certainty.  This type of calculation would not be possible without the placebo group in the trial. 

MP: What do we learn by including placebos? 

Joseph Romano: The placebo group is necessary to establish the safety of a product.  Even if a product is shown to be highly effective relative to a placebo, the product cannot be used if it also produces a significant number of side effects or adverse events relative to the placebo group.  In the case of HIV prevention products like microbicides, the importance of the placebo group to establishing safety goes beyond adverse events.  The people who will use these products are HIV negative.  Thus, it is crucial to show that the use of these products in no way enhances the potential for acquiring an HIV infection during the course of the trial.  One of the very early clinical trials of an N-9 based microbicide product demonstrated that use of this product led to an enhanced risk of HIV infection relative to people who used the placebo.  This was particularly important since the product used in this study was present in many over the counter products.  Thus, the placebo control not only served to show that this product could not protect against HIV infection, it was also the means by which this product was shown to have an increased risk of enhancing HIV infection.  The placebo control also allows for comparisons to be made during the course of the trial, prior to its completion.  Most trials are designed to have blinded review of the data from the treatment and placebo groups during the course of the study.  Again, by using certain calculations, it can be determined whether or not a product will likely be shown to be effective in a trial based on the analysis of data obtained partially through a study.  If these types of interim evaluations of a product relative to placebo show that it is highly unlikely for a product to be effective against HIV transmission by the end of the study, a trial can be stopped.  This early termination of a trail will obviously save significant amounts of money and resources, but more importantly, it will prevent continued experimentation in subjects with a product that is not likely to be of any benefit.  This use of the placebo group has been used to stop a number of HIV prevention trials, including specific microbicide trials.

MP: What is meant by the term “placebo window?”

Joseph Romano: The “placebo window” refers to the time period during which it will be feasible to conduct placebo controlled efficacy studies.  This period typically exists during the time when approved products for the intended indication are not yet available. Currently, there are no approved microbicide products available for HIV prevention.  Consequently, there is no established “standard of care” for this indication.  Without an established way of providing people with a product that is known to work for the indication, it is ethical to use placebo controlled trials since the placebo should provide no additional risk relative to people who are not part of the trials.  However, once a microbicide product has been adequately shown to prevent HIV infection, there will then be a standard of care available that provides more protection to people using that product, as opposed to people who would use a placebo.  With the availability of a product with well-established efficacy, it would then be unethical to enroll people into studies that involve a placebo product since people receiving the placebo product would essentially be denied access to something that affords some level of protection.  So, once a microbicide product has been adequately shown to prevent HIV transmission, it will no longer be possible to run placebo controlled trials, and the “window” will be closed.  It may even be the case that once any HIV prevention strategy is shown to prevent HIV transmission, it will be necessary to use that effective strategy in a trial designed to evaluate an alternative prevention strategy.  For example, if an oral PrEP strategy is shown to be effective at preventing HIV transmission before an effective microbicide product is available, it may be necessary to run future microbicide studies in comparison to the oral PrEP product. 

MP: Is the field adequately prepared for the day when the placebo window closes?  What needs to be done to prepare? And how will it be decided when that day comes? Who gets to decide? 

Read more »

On the Ground with Brian Kanyemba: A snapshot of advocacy in Africa

It’s one thing to read about HIV advocacy and prevention and another to experience it first-hand, on the ground, day to day. That’s how Brian Kanyemba experiences it. He is the research assistant at the Desmond Tutu HIV Foundation, a Mapping Pathways partner organization. A core part of Brian’s job involves traveling through South Africa’s villages and cities, talking to people about issues surrounding men who have sex with men (MSM), and what the prevalence of HIV means within this group of people. Of late, his focus has been on putting forward the “meaningfulness of Pre-Exposure Prophylaxis (PrEP)” within the South African context, especially for the MSM community. This is no easy task.

Let’s talk about sex
“South Africa is a really interesting and dynamic place,” says Brian. “We might have gay rights and rights access of services across all sexual orientations, but when you start to talk about MSM, or about PrEP as an intervention among MSM, this is faced by a huge mental wall.” This wall extends to talking about rectal microbocides as well, mostly due to the taboo against anal sex. Currently in development, rectal microbocides, or “topical PrEP”, are ARV-based products that might reduce the risk of HIV infection when used topically in the rectum during anal intercourse. These are in phase II, with an expected phase III to be carried out in Africa and possibly Cape Town (to learn more about rectal microbocides and PrEP click here and here). “No one will come forward to talk about this openly,” says Brian, “because in Africa, anal sex is associated with homosexuality, and homosexuality in Africa is not okay.”

One way Brian goes around this taboo is by using a simple game about sexual pleasure called “Mapping the Body”. While talking to people, he introduces the discussion on rectal microbicides by drawing three images on the board: a simple figure of a man, a woman, and another man. “I say, ‘Guys let’s put stars on areas where one can be sexually stimulated’,” says Brian. “You get amazing ideas from the group. And some people will say to put a star on the anal area, and then from there it is easier to link to PrEP and to introduce rectal microbocides.” By conducting a matter-of-fact discussion focused on pleasure and the body, Brian finds the group is much better able to accept the idea of rectal microbocides as a form of protection.

“Heck no… I am not interested.”
Despite his innovative methods, Brian has run into some pretty big walls where the topic of MSM and PrEP is concerned, especially within the healthcare sector and even the government. At a meeting with a parliament member who represents HIV issues, Brian recalls that when he brought up the topic of MSM and PrEP, she said, “’Oh no, can you please stop there because that doesn’t exist in my frame of mind.’” Says Brian, “This was a woman in the parliament whose job was to discuss issues of HIV. So, I’m talking to her about MSM being a group of people who have a high prevalence of HIV infection and she just says, ‘Heck no, we’re not going to talk about that topic now. I am not interested.’”

Brian clearly remembers his most unexpected encounter with homonegativity – it was at a focus-group PrEP presentation that he conducted in Durban, the third-largest city in South Africa. Recalls Brian, “I put the word MSM on the board, and do you know what one woman participant said? She said, ‘By MSM do you mean men who have sex with men? Yes, they must die; and if not, they must be killed!’” The woman participant who said this was on the community advisory board for one of the major HIV trials in South Africa, which made the statement all the more startling for Brian. “I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’”

A personal quest and mission
For Brian, the advocacy began many years ago in Zimbabwe, when he was just 19 and right out of college. He says, “As I was growing up, it was just accepted that being gay is bad. That is one of the reasons I left Zimbabwe, because of the way gay people are treated, are not spoken about.” He vividly remembers the moment that he began on his path as an HIV advocate, “A very close friend of mine was diagnosed with HIV and he was gay and, at the end of the day, he committed suicide. He didn’t understand HIV, he didn’t understand that it’s not a death penalty, he didn’t know that you can access treatment, he didn’t know that ARV treatment and care is available… and so advocacy become a passion, it was so personal to me.”

Despite the intense societal taboo, Brian worked in Zimbabwe on HIV and gay rights issues for almost a decade. His first job was with the National Army, working at the provisional hospitals on HIV and AIDS issues, ARV rollout, and providing counseling services for homosexuals. Says Brian, “I was working in the psychiatric department of the hospital… they realized I was gay, so they sent me to the lunatic asylum!”

Brian’s journey hasn’t been easy, and yet he continues with dedication, enthusiasm and hope. Why? Why not choose an easier job, an easier path? Brian’s response is prompt, “They say in my culture that when a funeral happens next door, you say ‘Ah ok, there is a funeral.’ But when a funeral happens in your house, it becomes a personal issue. When my friend passed away, I thought, ‘Ok, I need to put on my armour and start fighting this war now. I am going to stop this. I am going to stop thinking like a young person, and I am going to fight and go forward fighting for all my friends and for my community.’ It was very early in my life that I decided this, and I am not going to stop.”

Brian is a research assistant with the Desmond Tutu HIV Foundation, a Mapping Pathways partner organization. He is also an advocate fellow with the AIDS Vaccine Advocacy Coalition (AVAC), and is an active member of the International Rectal Microbicide Advocates (IRMA). He has been very involved with IRMA's Project ARM - Africa for Rectal Microbicides, and is an integral member of the Project ARM video working group, which is producing an African-focused video on anal sex and rectal microbicides.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]