Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

27 April 2011

In the Pipeline: Lab-on-a-Chip that Could Diagnose HIV in Minutes

Last month brought a potentially path-breaking announcement from an international team of researchers. The team has developed a self-powered blood-analysis chip (see Ivan Dimov's photograph on the left), which can process blood without the assistance of external tubing and other components. This means that it could be used to detect diseases like HIV and TB within minutes, revolutionizing the way these diseases are tested for.

The implications are exciting: The portable nature of the device would make it easy for field workers to it use for diagnosis, and the fact that it is made of plastic components means it could be manufactured in bulk at comparatively low prices.

Read more about this recent development here.

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

Highlights from the National Transgender Health Summit (U.S.)

"Transgender people experience significant health disparities in this country. In fact, regardless of socioeconomic status, transgender people are the most medically underserved population in the U.S."
- JoAnne Keatley, Director of the CoE for Transgender Health and the lead conference organizer (pictured)

via, by Jennie Anderson and Mindy Nichamin

What do empowerment, discrimination, data, and health have in common? They are several of the many themes we heard throughout the National Transgender Health Summit that took place in San Francisco earlier this month. The Center of Excellence for Transgender Health (CoE) organized this groundbreaking two-day Summit that brought together healthcare providers, health profession students, researchers, and other health leaders. In past posts we've discussed the disproportionate impact of the HIV epidemic on the transgender community, and so this Summit was an important opportunity for us to learn from and engage with experts on this topic. As the White House National HIV/AIDS Strategy states, "Some studies have found that as many as 30 percent of transgender individuals are HIV-positive. Yet, historically, efforts targeting this specific population have been minimal."

Read the rest.

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

26 April 2011

In Conversation with Jim Pickett: 'Success! Now What?'

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.

How was the Mapping Pathways initiative conceived?

JP: It’s a really exciting time for prevention. We have had some good theories and, now, initial data that we can safely and effectively use antiretroviral (ARV) therapies in the service of prevention, but our understanding is still evolving. While we’re researching and developing new tools (microbicides and PrEP) that we desperately need, and gaining new insights into how treatment for people living with HIV can also mean community prevention, there’s still a lot of confusion and debate surrounding these tools. So our team thought, ‘How do policymakers and programmers in all these different countries, how do they make sense of all of this complex, evolving data?’ Mapping Pathways is about trying to synthesize everything we know in the research arena with what community folks are saying, and doing some cost and evidence-based analysis to help come up with recommendations, or paths, to follow. 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.

Why is Mapping Pathways launching now versus 10 years later or 10 years earlier? Why now?

JP: In all the years of doing research into new prevention technologies – vaccines, microbicides, PrEP – we have not had anything show a glimmer of what we all could agree was ‘success.’ Results have tended to be flat. In this last year, we now have proof of concept that we really can create new ways to protect ourselves from HIV; in the field of biomedical prevention, the results from the IPrEx and CAPRISA trials are seen as the first real ‘win.’ So the second half of 2010 was the first time that we found strategies that actually could work. It was a momentous, revolutionary year for prevention, and we can now start building on that.

This is huge. Are people jumping up and down with excitement about the results from the IPrEx and CAPRISA trials?

JP: Yes, we are jumping up and down! In some ways, it’s been like Christmas every day since July at the International AIDS Conference in Vienna when the CAPRISA study results came out. But, jumping aside, we also are being very realistic. We’re saying, ‘Well, yes, so all these years we’ve been preparing ourselves for failure, and managing disappointment after disappointment, now we have success. And now that we have success, we have another 110% to do.’ We’ve gotten over this first hurdle; we’ve proven that we can create new ways to prevent HIV through the use of ARVs taken orally or applied topically but now we have to figure out how to get that pill, or gel, or whatever into the right hands in the right place at the right time. We’re grappling with all the problems that come with success. We’re certainly very excited to have these ‘problems’ – these are wonderful problems to have! Much better than flat results that haven’t allowed us to move forward. Now we’re over this hill and we’re moving forward and there’s another mountain to climb to address the next set of issues. But it’s a mountain we’re very happy to climb.

Could you spell out some of the main concerns or questions policymakers and communities are grappling with?

JP: Yes, first of all, this is new research… most folks, community people, program implementers want more information before moving into licensing and regulatory issues. Many policymakers are also reticent about PrEP because of cost, and they want to know more. But cost is a huge issue. In each of the countries where Mapping Pathways is focused – India, South Africa, and the United States – everyone who needs prevention does not have access. Not everyone who needs treatment is able to get on treatment. In many cases it is simply because there just aren’t enough resources. So where are they going to find the money? Where are these resources going to come from? What are they going to need to do to reprioritize their budgets and find the resources if they do think any of these interventions should be prioritized?

There are other concerns beyond fiscal issues. What’s going to happen to behavior in the community if we roll out PrEP? Will people stop using their condoms and will we actually have a bigger problem on our hands, since these tools as they are now (microbicides and PrEP) are less effective than condoms? Major ethical questions have also arisen over the use of ARV medications by healthy individuals when people living with HIV do not have access to treatment. In the US, we have an HIV drug waiting list right now – around 8,000 individuals. They are living with HIV and don’t have access to treatment. How do we provide PrEP to HIV-negative people in that context? How do we get those folks on treatment AND provide PrEP to those most in need, most vulnerable?

These are big questions that all of us (communities, policymakers, program implementers, donors) are going to need to answer. This discussion is of the moment, everything has just coalesced now, everything is happening now, and communities across the world are grappling with these strategies, wondering, ‘How in the world do we do this when we have all these other struggles? But on the other hand, how do we ignore it; how can we possibly ignore a new tool that could reduce so much suffering?’ And we have to realize that there are going to be different answers for different places in the world, or even in different parts and populations of one country. We’re hoping that the Mapping Pathways initiative will be able to provide some guidance to help figure all this out. There are so many complex issues to unravel and it is our duty to weed through all of these challenges, all of the promises, and all of the potential perils of these new strategies.

It sounds like you have quite a task ahead of you. How will Mapping Pathways know it has succeeded? How will you measure success?

JP: We will have succeeded if we’re able to provide analysis that is a blend of academic and scholarly work along with the wisdom from the folks on-the-ground delivering services and the people making policies at the government level. If we can bring together all of that knowledge and create tools that are usable for the various stakeholders, we will have succeeded. 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 and take it 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.

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

22 April 2011

Cambodia’s Doomed PREP Trial: What Happened Next?

via Speaking of Medicine, by Gavin Yamey

Remember the doomed PREP (pre-exposure prophylaxis) trial, examining whether tenofovir protects female sex workers (FSWs) from HIV, which was shut down by Cambodia’s Prime Minister in the face of pressure from activist groups? The serious public health implications of the trial’s termination were discussed in a 2004 PLoS Medicine essay:

“Speculation, unwarranted criticism, overreaction, or sensationalizing facts risk stigmatizing tenofovir and could jeopardize future attempts to find an efficacious PREP. This is in nobody’s interest.”

Last week, one of the Principal Investigators of that trial, Kimberly Page, gave a fascinating lecture at the University of California San Francisco, in which she told the audience how she turned the crisis of the trial’s shutdown into an opportunity.

The trial was literally shuttered overnight, said Dr Page, an epidemiologist who studies sexually transmitted infections (STIs). Fortunately, she said, “the NIH,” which funded the trial, “let me keep the money.”

A new research partnership was formed, which included community partners. Out of the ashes of the terminated PREP trial was born a new project, the Young Women’s Health Study (YWHS), which examines HIV risk factors among Cambodia’s FSWs.

Read the rest.

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

21 April 2011

Discontinuation of the FEM-PrEP Trial - a quick round-up

This week saw a major development in the HIV prevention field: the Independent Data Monitoring Committee (IDMC) for the FEM-PrEP trial  concluded that it would be unlikely to prove the effectiveness of Truvada in preventing HIV infection among the study population, i.e., HIV-negative women who are at risk of infection through sexual transmission. As a result, Family Health Iinternational (FHI) – which is implementing the trial with research centers in Africa – has decided to discontinue the study.

Get the details as well as FHI’s perspective on the FHI website.

The CAPRISA group thanked FHI for carrying out the study and providing extremely significant interim results, and the iPrEx team stated that they look forward to working with the FEM-PrEP team to understand the results better. NIAID (National Institute of Allergy and Infectious Diseases) released a statement expressing disappointment at the halt of the trial, emphasizing the need for continuing research, and confirming that it will continue with the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study while informing all current  VOICE participants about the FEM-PrEP results as early as possible.

The Microbicide Trials Network, the group conducting the VOICE study, issued a statement saying, "While it is disappointing that FEM-PrEP will not be able to provide information about Truvada for preventing HIV in women, the decision to stop the study should have no immediate impact on the VOICE study. VOICE is an ongoing trial involving women in Uganda, South Africa and Zimbabwe testing Truvada as well as the ARV tablet tenofovir and a vaginal microbicide containing tenofovir in gel form. VOICE will help determine which approach – daily use of the gel or tablet – is safe, effective and preferred by women for preventing HIV."

In The Wall Street Journal, Mark Schoofs outlined various possible explanations for the disappointing results, including potential adherence issues, as well as the physiological differences between men and women (essentially, these differences could mean a pill like Truvada may work better at preventing HIV infection among gay men or women with rectal exposure to HIV, than heterosexual women exposed vaginally.)  The New York Times deemed the termination of the trial “an unexpected setback” while the Washington Post discussed preliminary data.

South Africa’s Mail & Guardian presented the views of Dr. Khatija Ahmed of the Setshaba Research Centre in Pretoria. Dr. Ahmed led the research at one of the FEM-PrEP trial sites, and she points out that the halt of the trial “shows that you can't extrapolate that what happens in one population group will give you the same results in another population group.” She also stresses the need for ongoing research into HIV prevention options, given the high prevalence of HIV in sub-Saharan Africa.

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

Mapping Pathways at a Glance

What’s our mission?

Mapping Pathways aims to provide the research and analysis which communities and policymakers need in order to formulate coherent, evidence-based decisions for HIV/AIDS treatment and prevention strategies in the 21st century.

Who’s involved?

Mapping Pathways is a unique collaboration between six organizations:
  • The AIDS Foundation of Chicago
  • AIDS United
  • Baird’s CMC
  • The Desmond Tutu HIV Foundation
  • The Naz Foundation (India)
  • RAND Europe

How does this initiative work?

We will provide data and recommendations to policymakers, community leaders, and activists (and those who advise them) about the use of antiretroviral medicines to limit the number of new HIV infections by:
  • Finding out which information would be most helpful in making decisions about setting priorities and allocating health resources;
  • Conducting health economic analyses and secondary research to provide data;
  • Using sophisticated systems to establish an expert consensus on the relevance and reliability of the available analyses and information;
  • Providing its findings in forms that will be immediately useful, as well as choices and recommendations based on the findings.

Where are we focused, what’s our timeline, and who’s funding us?

Mapping Pathways is focused on the US, India, and South Africa. The findings could be adapted to other countries.

The program has already begun. Some preliminary findings and a progress report will be presented at regional AIDS meetings in Africa and North America in the fourth quarter of 2011. The work should be finished and ready to present at the 2012 International AIDS meeting in Washington DC.

Funding for the first year of Mapping Pathways is provided by Merck & Co. The project will need additional funding for its second phase.

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

The Big Picture: Pay off the Mortgage Early for Big Savings Later on

The hottest topic in HIV prevention these days is the use of antiretroviral (ARV) therapies to prevent transmission of the disease. These drugs are typically used to treat people living with HIV, but are being studied for ways in which they can actually prevent HIV as well.

There are several ways in which ARVs can be harnessed to prevent onward transmission. The first is getting more people living with HIV tested and into treatment. This approach, known as Test and Treat, Treatment as Prevention, and TLC+ (test, linkage to care, plus treatment) has been gaining currency in the last several years. Since people on treatment with undetectable viral loads are less likely to transmit HIV, it stands to reason that testing and linkage to care and treatment can reduce new infections in a community. The lower the “community viral load”, the much less likely an individual will come into contact with someone who could pass on HIV infection.

At the recent American Conference on Treatment for HIV, Julio Montaner, MD, of the University of British Columbia in Vancouver, likened putting people living with HIV on treatment as a mortgage – the more you pay now, the less you pay later. And researchers in San Francisco, where an aggressive new “Test and Treat” policy has been underway, have predicted they could reduce the infection rate among gay men and other men who have sex with men (MSM) by more than 60% over the next eight years if everyone diagnosed with an HIV infection began taking ARV drugs right away.

The other two methods utilizing ARVs as prevention involve providing the drugs to HIV-negative people, either orally, or through topical application in the vagina or the rectum. Oral prevention is known as PrEP (pre-exposure prophylaxis) and the topical application is known as a microbicide.

Two clinical trials testing these strategies – one in which women tested an ARV-gel vaginally and the other where gay men and other MSM took an ARV tablet by mouth – showed significant efficacy and reported their findings in the second half of 2010.

In July 2010 at the International AIDS Conference in Vienna, the Centre for AIDS Programme of Research in South Africa (CAPRISA) announced ground-breaking results from the first clinical trial to show that a microbicide could prevent HIV infection. The findings demonstrated that women who used a vaginal gel containing an ARV called tenofovir were 39% less likely to be infected with HIV compared to those using a placebo gel. Among women who were most adherent, the tenofovir gel decreased the chances of HIV infection by more than 50%. Interestingly, tenofovir gel also reduced a woman’s risk of contracting herpes simplex virus type 2 (a permanent and incurable infection that can increase the risk of HIV infection) by more than half. The trial’s findings need to be confirmed. A large multinational trial among 5,000 African women in Zimbabwe, Uganda, and South Africa called VOICE is currently comparing ARV oral tablets (Truvada and tenofovir) to ARV vaginal gel (tenofovir) formulations and could report results in 2012.

The second trial, a large multinational trial known as iPrEx, was “aimed at determining whether two ARV medications used to treat HIV/AIDS help prevent HIV acquisition in HIV-uninfected people at high risk of infection” ( In results published in the New England Medical Journal in November 2010, the iPrEx trial reported a 43.8% reduction in HIV acquisition by gay men and other MSM who took a Truvada tablet daily, compared to a placebo. Truvada is a combination product comprised of two different ARVs. Other PrEP trials among women, sero-discordant heterosexual couples, and injection drug users will report their data in the next couple of years.

So what exactly do these studies mean, and why are their findings significant? It is nothing short of a prevention revolution. The field has discovered two new strategies for preventing sexual transmission of HIV, and a future where individuals have more options to protect themselves beyond condoms is no longer just a theory, or a dream. ARVs, whether in the form of microbicides or pills, can be used as a strategy for prevention as well as treatment. Equally promising, treating people right after diagnosis (as opposed to waiting) will have a clear impact – it is unclear how big that will be – on the future of the epidemic.

While these findings are hopeful, they are still very preliminary and further testing is needed to confirm the results. Therefore, communities and policymakers are grappling with how they will incorporate this new information into their existing HIV/AIDS programs, systems, and structures. Complex questions around cost, accessibility, acceptability, resistance, long-term side-effects, infrastructure, and implementation remain to be answered.

This is where the Mapping Pathways initiative enters the picture. We feel that there is a clear and pressing need to provide these key stakeholders with the analysis and research that they need to form a well-rounded response to the rapidly changing scientific, socio-economic, and socio- political contexts in which intervention initiatives occur. In this way, we hope to map pathways to good decision-making for HIV prevention, intervention, and treatment options.

This blog is a space to record our journey as we gather information and, more importantly, to capture and encourage conversations about the challenges, successes, and debates that are shaping this pivotal crossroads in HIV/AIDs prevention and eradication history.

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