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
Highlights from the National Transgender Health Summit (U.S.)
- JoAnne Keatley, Director of the CoE for Transgender Health and the lead conference organizer (pictured)
via AIDS.gov, 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?'
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
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
- The AIDS Foundation of Chicago
- AIDS United
- Baird’s CMC
- The Desmond Tutu HIV Foundation
- The Naz Foundation (India)
- RAND Europe
- 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.
The Big Picture: Pay off the Mortgage Early for Big Savings Later on
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” (http://www.iprexnews.com/). 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.