AVAC Updates: Newest Issue of Px Wire and M2012 Road Map are Now Available!

via AVAC.org

This update provides a summary of and link to download the newest issue of Px Wire, as well as a roadmap for advocacy and communications-related sessions at the upcoming International Microbicides Conference (M2012).

Px Wire

Download the current issue of Px Wire (Volume 5, Issue 2), a quarterly update on biomedical HIV prevention research worldwide.

In this issue of Px Wire, we are excited to showcase a new ARV-based prevention timeline graphic, just in time for M2012. The timeline shows estimated efficacy trial end-dates, related confirmatory studies and dates of possible regulatory submission for a range of prevention options including oral PrEP with TDF, oral PrEP with TDF/FTC, vaginal and rectal formulations of tenofovir gel and the dapivirine-containing vaginal ring.

We also hope you enjoy reading the feature story in Px Wire where we describe the ongoing work of advocates who are working to influence PEPFAR Country Operating Plans.

Other highlights in this issue of Px Wire include:

• Information on how advocates can contribute their voices to the US FDA’s May 10 public meeting on Gilead Science’s submission for TDF/FTC (Truvada) as PrEP for HIV-negative adults

• Summaries of new AVAC resources: PrEP Using Daily Oral TDF/FTC or TDF in Women (and Men) — What the science tells us in March 2012, and new advocacy resources for voluntary medical male circumcision

• Upcoming events

2012 International Microbicides Conference (M2012)

Next week advocates, policy makers, researchers and funders will meet at the 2012 International Microbicides Conference taking place April 15-18 in Sydney, Australia. Building on past conferences, M2012 is a platform to discuss the latest in microbicides, PrEP and other ARV-based prevention research, as well as the basic science, structural, social and community issues that affect research and eventual rollout of these new tools. M2012 will feature several sessions that focus on advocacy and the role community advocacy and communication plays in the field. Our online conference “roadmap” highlights a number of these sessions. If you will be attending the conference, we invite you to join us at these events. Please visit the AVAC M2012 page for updates on these activities.

If you are not able to participate in M2012 in Sydney, please watch out for information on special AVAC post-M2012 webinars covering critical issues that emerge at the conference. For key updates during the conference visit NAM/AIDSMAP.

As always, if you have any questions please contact us at avac@avac.org.


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

Attitudes and acceptance of PrEP among key populations

via PLoS ONE, by Andreas B. Eisingerich, Ana Wheelock, Gabriela B. Gomez, Geoffrey P. Garnett, Mark R. Dybul, Peter K. Piot

Background

The use of antiviral medications by HIV negative people to prevent acquisition of HIV or pre-exposure prophylaxis (PrEP) has shown promising results in recent trials. To understand the potential impact of PrEP for HIV prevention, in addition to efficacy data, we need to understand both the acceptability of PrEP among members of potential user groups and the factors likely to determine uptake.

Methods and Findings

Surveys of willingness to use PrEP products were conducted with 1,790 members of potential user groups (FSWs, MSM, IDUs, SDCs and young women) in seven countries: Peru, Ukraine, India, Kenya, Botswana, Uganda and South Africa. Analyses of variance were used to assess levels of acceptance across different user groups and countries. Conjoint analysis was used to examine the attitudes and preferences towards hypothetical and known attributes of PrEP programs and medications. Overall, members of potential user groups were willing to consider taking PrEP (61% reported that they would definitely use PrEP). Current results demonstrate that key user groups in different countries perceived PrEP as giving them new possibilities in their lives and would consider using it as soon as it becomes available. These results were maintained when subjects were reminded of potential side effects, the need to combine condom use with PrEP, and for regular HIV testing. Across populations, route of administration was considered the most important attribute of the presented alternatives.

Conclusions

Despite multiple conceivable barriers, there was a general willingness to adopt PrEP in key populations, which suggests that if efficacious and affordable, it could be a useful tool in HIV prevention. There would be a willingness to experience inconvenience and expense at the levels included in the survey. The results suggest that delivery in a long lasting injection would be a good target in drug development.

Read the full study here.


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

Mapping Pathways South Africa: What we’re hearing so far

Original content from our Mapping Pathways blogs team

An important part of the Mapping Pathways project is to learn what people think and feel about ARV-based prevention strategies (such as PrEP), not just through academic streams and studies but also through everyday experience and wisdom. What do the people who work daily with treatment and prevention and/or have first-hand experience of living with HIV think? What are their concerns? What information do they need about PrEP, TLC+ (testing, linkage to care, plus treatment), and microbicides? Do they think these prevention tools can be useful for their community or country? Would they use them or prescribe them?

The Mapping Pathways online survey and in-depth stakeholder interviews are important ways for us to gain knowledge on these questions. Both processes took place over the year, and we’re starting to unpack a number of some interesting observations and ideas now that the interviews have finished and the survey is closed. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from South African doctors, policymakers, and activists on the ground.

Thoughts on the Mapping Pathways project
Although each person we spoke with had very different views on ARV-based strategies and HIV prevention within the South African context, most agreed that Mapping Pathways was an excellent and timely initiative. People thought the project was “inclusive”, “collaborative”, “captures everything that’s going on at the moment”, “well thought through”, “urgently needed”, “spot on”, and “a project worth doing”. One South African researcher felt it “hits the nail on the head about what needs to be done in the field”, and a South African policymaker said research like this is “the only way forward”. Concerns included the fact that only three countries are participating and that the field may be moving too fast to document everything effectively.

Thoughts on TLC+
Nearly everyone we spoke with agreed that TLC+ was scientifically valid – that is, to expand treatment access for people living with HIV as a way to reduce onward infections to others. “The prevention benefits of treatment are absolute,” said one South African clinician. However, some felt that it was tough to implement TLC+ in a resource-limited setting like South Africa, and there were concerns about infrastructure, cost, staffing, and sustainability. One South African pathologist said it was “a quantum leap”, a policymaker mentioned it was “operationally far away”, and an activist said that “financial sustainability in this context is unlikely”.

Others thought it could be done. “The programme will pay for itself,” stated a South African pathologist. Another added, “Keeping patients well is always a good thing financially.”Many people felt more research still needed to be conducted on such as side-effects, resistance, drug delivery, and adherence/acceptability. One South African epidemiologist pointed out the importance of operational research: “We do know enough to start finding out how we can do it.”

Thoughts on oral PrEP
There was a fair amount of concern about how oral PrEP could work within the South African context, especially given the country’s limited resources and high incidence rate. People were also confused by the seemingly conflicting results from various trials. (Read Daniella Mark’s thought-provoking interview on this here and here.) One South African researcher said, “The iPrEx and FEM-PrEP results have left us wondering.” Some people felt rolling out oral PrEP to high-risk populations was the right step; however, there were concerns expressed on how these populations would be defined and traced, e.g., adolescent girls, sex workers, and truckers.

Thoughts on microbicides
Microbicides evoked interesting and varied reactions from the people we spoke with. Most agreed that there still needs to be more evidence on their efficacy. “We’re not there yet,” said one South African epidemiologist. Some people felt a microbicide might be easier to implement than oral PrEP. One South African activist felt microbicides have the potential for much greater use. “If they’re like condoms and can be handed out freely to everyone, it would be easier,” said a South African policymaker.

Others thought differently, saying that a microbicide might be more difficult to implement than oral PrEP since it is a new modality and people are not used to topical prevention. “It might be difficult to know if you’ve put on enough,” said one South African pathologist. There were also concerns about acceptability and adherence. Read more about this here and here. What was also interesting was the view that a vaginal microbicide is female-controlled. “We’ve been seeking a female-controlled prevention methodology for a long time,” said a South African activist. “It is some small degree of female empowerment,” added a South African policymaker.

[Editors note: the VOICE trial announced November 25 the closure of its study arm testing tenofovir gel. The decision was made due to futility – while tenofovir gel was found to be safe, the trial was not able to prove the gel worked to prevent HIV. See the statement from the Microbicide Trials Network for more information. The Truvada tablet arm in the trial is continuing.]

Thoughts on HIV prevention funding allocation
The consensus on funding seemed to be that there was no “silver bullet” and South Africa should focus on multiple, concurrent strategies. “A one-size-fits-all approach won’t work,” said one South African researcher. There was also a general feeling that funds should go into proven, effective strategies. “Funders should think about where they will get the ‘biggest bang for their buck,’” said a South African policymaker. One South African activist remarked that the country doesn’t yet have a proper prevention strategy or prevention targets, which “leads to a scattergun approach and we miss people”. Some people strongly felt that the focus should be on treatment first. Others felt that funds should go to strategies that are female-controlled.

For more analysis on South African reactions towards ARV-based prevention  and HIV prevention in general, read our two-part interview with Daniella Mark from the Desmond Tutu HIV Foundation, a Mapping Pathways partner organisation: In Conversation with Daniella Mark: It’s a question of “how” in South Africa and In Conversation with Daniella Mark – Part 2: Climbing “Mount Everest”.

Mapping Pathways is presenting two posters at the ICASA 2011 conference showcasing some of the data collected. Stay tuned to this blog to see the actual posters – next week.

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

Tricky Terminology in HIV Prevention – Part 2: “Microbicides” and “Oral PrEP”

“I think elegance must take second seat to being clear and helping people absorb vast amounts of new information.”

We recently blogged about the terms “abstinence” and “being faithful” – words that have caused a great deal of controversy in the HIV prevention arena. In this post, we discuss another instance of tricky terminology – the need to maintain the distinction between “oral PrEP” and “microbicides,” a difference that is extremely important in the context of the rapidly changing face of HIV prevention.

Lori Heise of the London School of Hygiene and Tropical Medicine has some thoughts on this matter. “In the next few years, as policymakers, providers, and potential users are trying to get their minds around all this new research and the expanding array of prevention options” she says, “it is absolutely essential that we stick to the language of ‘oral PrEP’ and ‘microbicides’ (for instance: ‘oral tenofovir’ or ‘tenofovir gel’).”

There has been a move within scientific circles to shift the language toward PrEP and ARVs, just making distinctions between mode of delivery (topical, oral, systemic), and there are supporters of this formulation. “However, as we shift from clinical trials into introduction and use,” she says, “we need every means at our disposal to help people make appropriate distinctions among methods.”(See this Mapping Pathways blog post for a snapshot of the various ways in which antiretrovirals can be used to prevent new HIV infections.)

Clear and accurate terminology help policymakers, advocates, and other stakeholders engage in rational discussions about which methods might best suit the needs of different individuals at different moments in time and with which types of partners or sexual settings. Substituting words or using umbrella terms tends to cloud clarity and cause confusion. “Over the last several months, I have sat through a number of presentations that combine information about oral PrEP and microbicides, but use the language of PrEP to describe both.” Lori recounts. “Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions that mostly apply to microbicides or to oral PrEP, to both.There is a tendency to talk about PrEP and topical PrEP – but people don't register the ‘topical’ and so important nuances are lost.”

Indeed, these different products have critical distinctions to keep in mind. For instance, oral PrEP may potentially protect a wider range of users than microbicides, such as in the case of injection drug users (IDUs) whose primary risk of HIV infection is from tainted syringes, not unprotected sexual intercourse (though we are still waiting on data on the efficacy of PrEP among IDUs. Then, the license to develop tenofovir gel as a microbicide is held by the public sector, while the licenses for oral tenofovir and Truvada – both of which are already available for treatment – are controlled by Gilead. This dual-use issue where ARVs taken orally can be used for either treatment or prevention doesn't exist for any microbicide.

“These distinctions are important, and I think we need to use terminology that helps people keep them in the forefront of their minds – at least for the next few years, as we broaden the circle of discussion to add groups that as yet know very little about PrEP or microbicides....In this case,” says Lori, “I think elegance must take second seat to being clear and helping people absorb vast amounts of new information.”


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