New International Report on HIV Prevention Urges Localized Consideration of Antiretroviral Strategies

First Report on Antiretroviral Drugs for HIV Prevention to Bring Science Together with the Wisdom of Communities

June 19, 2013 – To make an impact on new HIV infections globally, antiretroviral (ARV)-based HIV prevention strategies need to be closely tailored to local contexts and cultures, according to a new report released today by RAND Europe and AIDS Foundation of Chicago.

“‘Mapping Pathways: Developing Evidence-Based, People-Centred Strategies for the Use of Antiretrovirals as Prevention’ [available by open access online on the RAND Europe website, and on the Mapping Pathways blog] provides an important resource to help communities, prevention programmers, funders and policymakers decide whether, and how, an ARV-based strategy could work in their locality,” said Jim Pickett, director of prevention advocacy at AIDS Foundation of Chicago and project director.

Last year, more than 2 million people globally became infected with HIV suggesting current prevention strategies are not doing enough to halt HIV transmission. Research suggests that some of the most promising prevention strategies are based on ARV drugs, such as pre-exposure prophylaxis (PrEP) and treatment.

“However, just because we know that ARVs can prevent HIV infection does not mean that we will, in practice, successfully implement their use in communities that need them,” said lead author Molly Morgan Jones, research leader at RAND Europe in Cambridge, UK.

Mapping Pathways is a community-led research project on the strategic use of ARV drugs for HIV prevention, involving RAND Europe, AIDS Foundation of Chicago and other partners in India, South Africa and the United States.

The group engaged more than 1,000 community respondents with an online survey and interviewed several dozen key stakeholders, including policy experts, program implementers, health care professionals and advocates. Participants rated the importance of various ARV-based prevention strategies, shared their perspectives regarding barriers to implementation and suggested the kinds of information they needed to make informed decisions about whether to implement any ARV-based strategy.


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Additionally, an extensive literature review was conducted during 2011 and 2012 to assess the published scientific evidence. Detailed snapshots from these activities are highlighted in the report and provide rich, localized context that reveal the opinions and concerns of a wide array of individuals and underscore important gaps in the evidence.

Community members and key stakeholders in each country consistently agreed they must address three key challenges in order to maximize the prevention potential of ARV drugs:

• First, structural issues such as community-level living conditions that affect access, such as proximity to appropriate health care and other social determinants of health, are as important as individual-level behaviors.

• Second, more information about implementation is needed by policymakers, funders and prevention programmers in order to determine what mix of ARV-based prevention strategies, if any, are appropriate.

• The third challenge is to adapt ARV-based prevention strategies for local contexts, as reflected in the book’s foreword written by Archbishop Desmond Tutu (“All science is local”).

The research found that within each country, and among varied types of people, the same sets of scientific data were interpreted and framed in different ways depending on the local context and perspectives. For instance, participants in South Africa and India tended to view the scientific data with more skepticism than individuals from the United States, so the successful adoption of ARV-based prevention strategies, such as PrEP, requires consideration of both the science and the local context.

 “It is important to marry the published evidence with the wisdom of communities to make decisions on prevention programming that make sense locally, for communities to map out their own, unique pathways,” Jones said.

Moving forward, there are many considerations for the use of ARVs as prevention in localities.

“Different countries and communities are at different places,” said Dr. Linda-Gail Bekker, deputy director of the Desmond Tutu HIV Foundation in South Africa and a Mapping Pathways partner. “We all have to ask policymakers, funders, and ourselves a host of questions. How will we implement a certain strategy? How will we pay for it? Is it for the generalized epidemic or is it only for certain key populations? What are the social factors that make certain populations vulnerable? Is this strategy ethical? Does it make sound public health sense? What won’t be afforded if we go this route? Who will benefit if we do?

“Meanwhile, we must continue to advocate and conduct implementation science so that we can show policymakers what is feasible and what the impact in the public sector could be.”


[Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

Big pharma is cut out by India's plan to bring medicine to masses

via The Independent, by Nikhil Kumar

India is planning a multibillion-dollar push to bring free medicines to the hundreds of millions of its citizens who, despite the country's economic revival, still languish without access to the very basics of health care.

The $5bn initiative, which is slated to be rolled out by the end of this year, will offer 348 essential drugs to patients across the country. In a blow to the West's big pharmaceutical firms, the planned scheme will largely cut out branded drugs, opting instead for cheaper generic alternatives.

News of the plan comes as the Congress-led administration in Delhi attempts to shore up public support after a raft of corruption scandals and crushing electoral losses in state polls. A recent report confirming a slowdown in economic growth has only served to sharpen criticism of the government.

Now, Delhi is plotting a multi-billion dollar health-care drive, using its network of government-funded hospitals and clinics to deliver free drugs across a country where, despite the much-vaunted boom of recent years, more than two million young children die every year from preventable infections, according to Unicef.

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.]

Views of policymakers, healthcare workers and NGOs on HIV pre-exposure prophylaxis (PrEP): a multinational qualitative study

[This is of great interest to the Mapping Pathways team as our work is quite similar. Very interesting!]


via British Medical Journal, by Ana Wheelock, Andreas B Eisingerich, Gabriela B Gomez, Emily Gray, Mark R Dybul, Peter Piot

Abstract

Objectives To examine policymakers and providers' views on pre-exposure prophylaxis (PrEP) and their willingness to support its introduction, to inform policy and practice in this emerging field.

Design Semistructured qualitative interview study.

Setting Peru, Ukraine, India, Kenya, Uganda, Botswana and South Africa.

Participants 35 policymakers, 35 healthcare workers and 21 non-governmental organisation representatives involved in HIV prevention.

Results Six themes emerged from the data: (1) perceived HIV prevention landscape: prevention initiatives needed to be improved and expanded; (2) PrEP awareness: 50 of 91 participants had heard of PrEP; (3) benefits of PrEP: one component of the combination prevention arsenal that could help prioritise HIV prevention, empower key populations and result in economic gains; (4) challenges of PrEP: regimen complexity, cost and cost-effectiveness, risk compensation, efficacy and effectiveness, stigmatisation and criminalisation, information and training and healthcare system capacity; (5) programmatic considerations: user eligibility, communication strategy, cost, distribution, medication and HIV testing compliance and (6) early versus late implementation: participants were divided as to whether they would support an early introduction of PrEP in their country or would prefer to wait until it has been successfully implemented in other countries, with around half of those we spoke to supporting each option. Very few said they would not support PrEP at all.

Conclusions Despite the multiple challenges identified, there was general willingness to support the introduction of PrEP. Yet, strengthening existing HIV prevention efforts was also deemed necessary. Our results suggest that an effective PrEP programme would be delivered in healthcare facilities and involve non-governmental organisations and the community and consider the needs of mobile populations. Comprehensive information packages and training for users and providers would be critical. The cost of PrEP would be affordable and possibly segmented. Extensive counselling and innovative monitoring measures ought to be considered.

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.]

Find Mapping Pathways at AIDS 2012

Original content from the Mapping Pathways blog team

The Mapping Pathways team will be participating in a number of sessions at the International AIDS Conference (AIDS 2012) in Washington, DC this July. Please check out our list of activities below, and join us!

We will be sharing data we collected in 2011 from India, South Africa and the United States - all related to the utilization of ARVs as HIV prevention. Community and stakeholder perspectives from the "grassroots" and the "grasstops" will be highlighted in each of our focus countries, and sharing an analysis of an extensive literature review conducted by RAND.

Mapping Pathways at AIDS 2012

Click on "View on slideshare" to download the PDF. We hope to see you in DC!

[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.]

Mapping Pathways Presents on PrEP Community Perspectives at IAPAC Summit

Original content from the Mapping Pathways blog team

Click below for slides presented by Mapping Pathways' Jim Pickett (AIDS Foundation of Chicago) today in London at IAPAC's Evidence Summit on TasP and PrEP. Several members of the Mapping Pathways team have been participating in the Summit as well, helping to disseminate our findings from data collection activities we undertook in 2011.

The full program from the June 11 - 12 meeting in London, and all slides presented, are available on the IAPAC website now. They are a fantastic resource for individuals and organizations who are following these issues.

IAPAC Summit on TasP and PrEP Jim Pickett Mapping Pathways

View more PowerPoint from Jim Pickett

Click on "slideshare" to download the slides.

[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.]

Reuters: India Should Tax Air Tickets to Pay for AIDS Drugs - U.N.

via Reuters.com, by Nita Bhalla

Millions of the world's poorest people could have easier access to life-saving drugs if India introduces an air ticket tax to help fund purchases of cheap medicines for HIV/AIDS, malaria and tuberculosis, a senior U.N. official said.

UNITAID, a U.N. agency which negotiates for cheap medicines from pharmaceutical manufacturers to treat deadly diseases, is lobbying countries such as India to join its air ticket levy initiative which began in 2006.

Under the program, countries put a nominal amount on the cost of air tickets which funds UNITAID to buy drugs for patients in the developing world. Ten countries have imposed the levy, generating $200 million annually for cheap medicine.

"What we want in India is a similar system by which a very small contribution which is painless to the traveler can be applied to large numbers of travelers," UNITAID Executive Director Denis Broun told AlertNet in an interview.

"Since air traffic is very high in India, the small amount of levy makes a huge difference to the amount of drugs that we can purchase and the number of poor who can benefit from them."

HIV/AIDS, malaria and tuberculosis kill 4.4 million people each year, UNITAID says. Approximately 14.2 million people are in need of anti-retroviral drugs globally, yet more than half cannot afford them.

India's airlines are reeling under a debt load of $20 billion and lost $2 billion last year, as high fuel prices, a weakening rupee and competition kept fares low and costs high.

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.]

India's Involvement to the Change of HIV/AIDS

via the Hindustan Times, by Sanchita Sharma

A decade ago, New Delhi’s The Ashok turned away a dozen gay men who wanted to book a conference room at the hotel for a think-in on AIDS, which was still labelled a gay man’s disease. It took several phone calls from the senior bureaucracy at the Union Health Ministry’s National AIDS Control
Organisation (NACO) to get them a 12x12 conference room for one day.

“Five years ago, the same group of men who have sex with men (MSMs, the politically correct term for homosexuals) organised a huge convention at The Ashok, with 700 MSM and transgender participants overrunning the hotel for days. Laws may not have changed in the courts or in the books, but the law in the streets has changed, and this amazing turnaround in society’s attitude has happened because of AIDS,” says JVR Prasada Rao, former Union health secretary and National AIDS Control Organisation (NACO) chief, who was appointed the UN Special Envoy for AIDS in the Asia Pacific region this week.

Safe and sound, legally

 Change in social attitude is fantastic, no doubt, but it is not enough to keep new infection down. Legal environment around people most at risk — homosexuals, injecting drug users and sex workers — has to change to encourage them to seek HIV-prevention and treatment services that have been proven to cut down new infections dramatically, not just in India but everywhere around the world.

Last year, the HPTN052 study — HIV Prevention Trials Network’s study that was declared the Breakthrough of the Year 2011 by the journal Science — showed that if an HIV-positive person adheres to antiretroviral therapy (ART) used to treat AIDS, the risk of transmitting the virus to their uninfected sexual partner is reduced by 96%.

In March this year, the Africa Centre for Health and Population Studies reconfirmed the HPTN findings by presenting data showing that in areas where ART uptake is high (greater than 30%) people who do not have HIV are 38% less likely to get infected with the virus as compared to areas of low uptake (less than 10%).

With 7.4 million on HIV treatment globally, new HIV infections have fallen in 33 countries since 2001, though mostly in Africa and Asia. UNAIDS credits the halving of India HIV-infected people to 2.39 million to both improved data collection methods and an actual fall in new infections because NACO provides 4.48 lakh people free anti-retroviral therapy (ART), which lowers the HIV load in the body and lowers the risk of infecting partners while helping the infected live healthier and longer.

Read the Rest.


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

The Influence of India's New Ruling on HIV/AIDS Pharmaceuticals

via Reuters.com, by Kaustubh Kulkarni and Henry Foy

"India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say."

On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India.

It is only the second time a nation has issued a compulsory license for a cancer drug after Thailand did so on four drugs between 2006 and 2008, also on affordability grounds. Thailand also issued licenses for HIV/AIDS and heart disease treatments.

"This could well be the first of many compulsory rulings here," said Gopakumar G. Nair, head of patent law firm Gopakumar Nair Associates and former president of the Indian Drug Manufacturers' Association.
"Global pharmaceutical manufacturers are likely to be worried as a result ... given that the wording in India's Patent Act that had been amended from 'reasonably priced' to 'reasonably affordable priced' has come into play now."

The new wording is seen as a lower threshold for compulsory licenses, which can be issued under world trade rules by nations that deem major life-saving drugs to be too costly. The licenses allow them to authorize the local manufacture or importation of much cheaper, generic versions.

Global drugmakers see emerging markets such as India as key growth opportunities, but remain concerned over intellectual property protection. Nair said HIV-related medicines were likely to be the most at risk by compulsory licenses in the future.

India has one of the world's fastest-growing rates of HIV and heart disease is also the country's biggest killer, but widespread poverty in Asia's third-largest economy makes many non-generic drugs unaffordable for millions.

Read the Rest.


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

In Conversation with Nomita Chandhiok: Exploring the ‘tool box’ of HIV prevention strategies

Original content from the Mapping Pathways blog team

“If a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with – something that can help put her in control.”

Doctor Nomita Chandhiok is one smart lady. A gynaecologist by training, she is a scientist and researcher in the Division of Reproductive Health at the Indian Council of Medical Research (ICMR), the premiere research body of the government of India. Her job is to identify issues related to women’s health, sexual reproductive health, women’s infection, and HIV prevention that are relevant to India, and then conduct and coordinate studies that push forward research on these issues.

“HIV is a high priority for the Council,” says Dr. Chandhiok. “ARVs as prevention have really evolved.” She explains that all HIV prevention and treatment policies fall under the Indian government’s NACO programme. “As part of this programme, we would promote HIV prevention strategies such as PrEP or microbicides. Our focus so far has been on promoting condom use and safe sex practices, but now there could possibly be these new tools as well.”

Creating the toolbox
In particular, the ICMR is currently running a number of pre-clinical trials for product development and screening for microbicides. The organisation recently finished a Phase 1 trial that looked at an indigenously produced microbicide called Basant (the product is curcumin/turmeric based). The product was tested on 30 women and was found to be safe, says Dr. Chandhiok. Further studies would explore the post-coital efficacy of Basant and its male tolerability in 30-40 men. A study is also ongoing to identify and prepare six sites in the country for phase III microbicide trials. Dr. Chandhiok explains that these sites are located in three high-prevalence Indian states – Maharashtra, Andhra Pradesh, and Karnataka. The ICMR is seeking to determine the HIV incidence and prevalence rate amongst 9000 commercial sex workers in six districts in these areas. “Once we know the incidence rate, and if it is high enough (say 3-4% or more), we will then develop these sites for future HIV prevention trials.”

An empowerment tool for Indian women
Dr. Chandhiok has been working in this area for almost a decade. In 2003, she received a Fogarty Fellowship at Brown University, where she was exposed to research on microbicides as an HIV prevention tool.  “In early 2000, people thought HIV was going to spread like wildfire in India,” explains Dr. Chandhiok. As a result, the ICMR was looking ahead to find new prevention tools that they could possibly add to the government’s existing arsenal of HIV prevention strategies. As it turns out, the epidemic did not spread as imagined. “HIV is still a big issue in our country, but our numbers are better now… We don’t have a general epidemic. So, given the nature of the epidemic in India, any tools we develop will be for specific populations.”

Dr. Chandhiok explains further, “We talk in terms of a prevention toolbox. We don’t talk about one general tool. The aim is to provide several options that a person could  use through their entire sexual life. So, for example, you have a choice – if you can use a condom, great; if not, then you have the option of using a microbicide also.”

Dr. Chandhiok feels that prevention tools such as microbicides, once their efficacy has been proven and effective products created, could serve to empower Indian women. “As an empowerment tool for women these prevention tools need to be developed.” She explains, “These are very important for us to look at because if a woman, for whatever reason, is unable to negotiate the use of a condom during sex, at least she can have something else to protect herself with—something that can help put her in control.”

Concerns and challenges
Dr. Chandhiok is quick to point out that a lot of this discussion, though, is still theoretical. “At this point, we don’t have enough data to roll out tomorrow. There are still questions to be answered. We’re not at the point of saying we are ready to roll.”

For instance, she explains that oral PrEP, even were its efficacy to be proven, would still run into a huge implementation challenge in India. “In India, we don’t have strong regulation. You could be able to buy an ARV without prescription. So for something like PrEP, which is pill based, you don’t want people using it just like that without a proper prescription or a trained professional administering it and providing proper information and counselling.”

Dr. Chandhiok also feels that because HIV isn’t seen as such a priority issue amongst the majority of the population, adherence issues are another challenge, “Prevention is different from treatment. Only if I perceive myself at risk, only then will I think of preventing it.” And, as Dr. Chandhiok explains, in India most people do not perceive themselves as being at risk – HIV is perceived as a problem relegated to those at the margins of society, commercial sex workers or men who have sex with men. “Basically, for us to be able to roll out something like PrEP, we need government commitment, we need the funds to procure it, and we need a system to reach all the people who require it.” And, as it stands now, all three of these factors remain unclear.

The first and most important hurdle, however, is to prove the efficacy of these new prevention tools, says Dr. Chandhiok. “Only once efficacy is proven, can we even begin to think of all the implementation issues. And as it stands now, the trial results are contradictory; so we are still not too certain about how to proceed.” (Learn more about the various HIV prevention trials here).

Particularly disappointing was the closure of the VOICE trial’s study arm testing tenofovir gel last November, says Dr. Chandhiok. “I’m a little confused because of all the conflicting results. There is no one direction as yet, so we don’t know the clear path ahead. We can’t move forward until we have clear-cut evidence that these tools work.”

Note: The VOICE trial announced on November 25, 2011 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. Previously, the trial had to drop its tenofovir tablet arm due to futility as well. The Truvada tablet arm in the trial is continuing.

Nomita Chandhiok is the Deputy Director General in the Division of Reproductive Health at the Indian Council of Medical Research, the premiere research body of the government of India.



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

Misconceptions surrounding HIV problematic in India

via The Times of India

Twenty-five years after the first case of HIV/AIDS was reported in the country, experts say the main target in the fight against the disease is misconceptions. After releasing the 13th Behaviour Surveillance Survey Round XIII for 2011, experts in the field said that awareness among the public had gone up but awareness without misconception was low.

Many believe that healthy-looking people have a good immune system and may not test positive for HIV/AIDS. Doctors have been trying to tell people that antiretroviral drugs - the medicines of choice for HIV/AIDS - will only keep the viral load low, but many assume they are safe after taking them. "We require schemes to target misconceptions. Only awareness without misconceptions will strengthen the fight against HIV," said AIDS Prevention And Control (APAC) project director Dr Bimal Charles.
Dr Charles said that in the surveys, people had said cleaning the vagina with vinegar or having sex with monkeys would keep out the infection.

The annual survey report, by APAC project along with Tamil Nadu State AIDS Control Society (TANSACS) and USAID, has been prepared since 1996. The survey is conducted among high-risk groups like female sex workers, gays and injecting drug users and bridge population groups such as truckers and migrant workers.

With a sample size of 5,000, the field work was done in November and December 2011 across 15 towns in Tamil Nadu. The results showed a significant improvement in the behaviour among targeted groups where NGOs were working.

Read the rest.


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

Migrant population bears highest burden of HIV in India

via The Times of India, by Kounteya Sinha

Migration is fuelling India's HIV epidemic. National AIDS Control Organisation's latest figures show that besides high risk populations like sex workers, the highest burden of HIV is among migrants - 3.6%, which is 10 times the HIV prevalence among the general population.

With migration rates increasing, the prevalence will only get worse. According to the 2001 census, 30.1% of the population was considered to have migrated (314 million) - a considerable increase from 27.4% in 1991. NACO has, therefore, identified 108 railway stations - which are both source and destination of migrants travelling in search of work. These are now the focus of the country's anti-HIV fight.

Red Ribbon Express (RRE), which chugs out of Delhi on Thursday, will stop at most of these 108 identified stations to test migrants for HIV besides carrying out counselling and spreading anti-HIV messages. During it's year-long journey, RRE will traverse through 23 states, cover 30,000 km and stop at 162 stations.

Speaking to TOI, a NACO official said, "Migrants are one of the major focus areas this time with the RRE. Last year, RRE stopped at 152 stations and reached out to 8 million people directly. This time, around 30-40 stops will be to mainly address migrants."

NACO has identified 122 districts with high out-migration across 11 states which are on priority for starting up community level interventions. Another 75 important transit locations have been identified across these 122 districts from where these migrants usually board long distance trains/buses to reach their destinations.

Studies on the relationship between migration and HIV conducted by NACO in three popular migration corridors - Ganjam-Surat, Darbhanga-Delhi and Azamgarh-Mumbai - threw up shocking findings. It showed that two to four times more number of informal workers had non-regular partners or visited sex workers with only 25% using condoms. Around 5% male migrants and 13% female migrants reported sexually transmitted infections, nearly double the national average.

Read the rest.


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

Mapping Pathways 2011: The year in voices

Original content from the Mapping Pathways blog team

“We are on the verge of a significant breakthrough in the AIDS response. The vision of a world with zero new HIV infections, zero discrimination, and zero AIDS-related deaths has captured the imagination of diverse partners, stakeholders and people living with and affected by HIV. New HIV infections continue to fall and more people than ever are starting treatment. With research giving us solid evidence that antiretroviral therapy can prevent new HIV infections, it is encouraging that 6.6 million people are now receiving treatment in low- and middle-income countries: nearly half those eligible.” - Michel Sidibe, UNAIDS Executive Director, World AIDS Day report


Earlier this month, WHO and UNAIDS released a World AIDS Day report providing a snapshot of goals and progress made in 2011 toward HIV/AIDS prevention. We thought we’d provide a snapshot of the Mapping Pathways project as well – but through the voices of some of the most memorable and inspiring people we spoke with this year.

APRIL:
“It’s been like Christmas every day since July at the International AIDS Conference in Vienna when the CAPRISA study results came out… 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.” - Jim Pickett: ‘Success! Now what?’
   
MAY:
“There is a threat – still distant but definitely visible – that we will lose this astonishing success through complacency… We can make AIDS rare – and eliminate it entirely from rich countries – using technologies that we already have. The question is whether we have the will to do it.”  - Mark Chataway: Using antiretrovirals to prevent new infections

“There’s still so much we don’t know, and these are open questions rather than being settled questions… we can’t prove that the intervention worked, and we can’t prove that the intervention didn’t work … There are still things to be learned.”  - Julie Davids: FEM-PrEP closure update – What does ‘futility’ mean exactly?

“I think whenever the field starts to go on emotion, we get into trouble… Human behavior keeps messing up the plot.”  - Dr. Linda-Gail Bekker: Of Mice, men, and microbicide trials   

JUNE:
 “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!’ I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’” - Brian Kanyemba: A snapshot of advocacy in Africa

“The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts. First, in terms of the potential of this strategy to reduce transmission, it is clearly an effective option… Of course, there are some issues associated with this strategy as well.”  - Dr. Joe Romano: Thoughts on the microbicide pipeline and the recent HPTN 052 results

“I believe that it is a political, economic and human tragedy that the first time our country has had a national HIV/AIDS strategy is exactly at the same time that we’re being told there are no resources to put it fully into place... We are, in significant ways, being restrained from putting our best minds and hearts at the forefront of this effort. When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded.”  - Julie Davids: The economic effect of HIV/AIDS in the US

JULY:
“Sex sells. People in the commercial world use sex to sell things like cars, toothpaste, pens…almost anything! Why not use sex to sell safer sex?”  - Anne Philpott: How sexy sex can help prevent HIV transmission

“Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against. Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.”  - Dr. Sonali Kochhar: PrEP in India

AUGUST:
“My sense is that many people are still very uncomfortable and not quite able to figure out why we’re talking about PrEP in the Indian context. Many senior people in the field feel the focus needs to be on TLC+.”  - Anjali Gopalan: Notes from India – concerns and challenges around PrEP

“The matchmaking started because people living with HIV don’t disclose their status to their parents. In India, when the boy is 30 or the girl is 24-25, the parents want them to get married. They start looking for partners and the person who is infected is unable to talk freely to them and say, ‘Look, I have HIV and I can’t get married.’ That’s when they come to me and ask, ‘My parents are planning to get me married to an HIV-negative person – now what do I do?’ So we say okay, we’ll look for someone for you."  - Dr. Suniti Solomon: A modern-day HIV love story

“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.” - Dr. Linda-Gail Bekker: Safe-sex education – too little, too much?

“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… 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."  - Dr. Joe Romano: What happens when the ‘placebo window’ closes?

SEPTEMBER:
“It boggles me that I still have to make the case for understanding the relational and contextual nature of HIV transmission and the need to recognize that people and technologies are interactive and interdependent."  - Judith Auerbach: Addressing social drivers of HIV/AIDS

“Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions...”  -  Lori Heise: Tricky Terminology in HIV Prevention – Microbicides and Oral PrEP

“Giving gay men more information about their health only empowers them to make informed decisions. The fear that gay men will take PrEP, forego condoms and become out of control disease spreaders, harkens to the days when men feared women would become crazed nymphomaniacs thanks to the new birth control pill.” -Alex Garner: Open letter Urges that PrEP debate should be based on ‘facts not misinformation’

OCTOBER:
“Firstly, we need to work out whether this result is true or not. But even if it is true, it’s quite possible that we need to balance the benefits of avoiding an unwanted pregnancy against the small increased risk of acquiring HIV infection.”  - Dr. Tim Farley: Hormonal contraceptives and HIV – the grey area

“It’s really critical we know what research is and is not being done, what evidence does and does not exist, so that we have a solid understanding of the implications of these technologies in various social, economic, cultural, and political contexts that exist in different countries. It’s only then that we can begin to think about investing in them and the best ways to implement them."  - Molly Morgan Jones: Mapping Pathways so far – the ‘literature review’

NOVEMBER:
“If you’re talking about early treatment, you’ll have one person saying, ‘This is a quantum leap from where we are now, and it’s operationally impossible.’ And then you’ll have another person saying, ‘Well, if you have cancer, the doctor doesn’t wait till you’re half dead to give you the treatment, and so we should have been doing this years ago.’ And both are very valid points; it’s just how do you get those two people, who are equally important in making this happen, make it happen?” - Daniella Mark: It’s a question of ‘how’ in South Africa Part 1 & Part 2

DECEMBER:
“PrEP … is hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers.” - Jim Pickett: Triumphs and Trials in 2011


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

Five hundred twenty-five thousand six hundred minutes: How do you measure a year?

Original content from the Mapping Pathways blog team

Another year winds down, and it is time to take stock, to reflect on all the moments that have made 2011 an important year for the HIV prevention community – and for all those of us who hope for and work toward the end of the HIV/AIDS epidemic.

The year began on a high note: the extremely encouraging results from the IPrEx and CAPRISA trials, announced in 2010, had us “jumping up and down” as 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) says in his memorable interview, Success! Now What? These results were the long-awaited proof of concept for new prevention technologies – the “first real ‘win’” after many years of hard work.

The first bump in the road was the discontinuation of the FEM-PrEP trial in April due to futility, when the trial’s Independent Data Monitoring Committee concluded that the study would be highly 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.

The unexpected development had everyone expressing their opinions and wondering about the implications – after all, what does “futility” mean exactly? Dr. Linda-Gail Bekker (an expert in the field of biomedical trials and research) cautioned against knee-jerk reactions to the trial closure in her interview with Mapping Pathways: “Wait for the evidence, I think that is the message. Extrapolate at your peril. We know only what we know, and we need to just work within that.”

Then came the HPTN 052 results – and we were jumping with excitement again! The study demonstrated that initiation of ART by HIV-infected individuals substantially protected their HIV-uninfected sexual partners from acquiring HIV infection, with a 96 percent reduction in risk of HIV transmission. In an interview with Mapping Pathways, microbicides expert Joe Romano captured the overall sentiment, saying, “The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts.”

There was good news for India (a Mapping Pathways target country) too: a UNAIDS report stated that the rate of new HIV infections fell by more than 50% in India between 2001 and 2009, double of the average decline in the world. The PrEP debate in India continued through the year. “There is a lot of concern in the country, especially with global funding not available right now,” explains Anjali Gopalan (Executive Director of NAZ India, a Mapping Pathways partner organization), in Notes from India: Concerns and Challenges Around PrEP. Mapping Pathways also published a short post on what we’ve been hearing in India so far.

Soon after the HPTN 052 results, the FACTS 001 trial was announced in South Africa – a follow-up study to confirm the effectiveness of tenofovir and to verify the CAPRISA 004 results in “larger, more diverse populations.”

Around this time, Mark Chataway (co-chairman of Baird’s CMC, a Mapping Pathways partner organization) was in South Africa (a Mapping Pathways target country). “My visit to the country once again brought into sharp focus for me just how significant South Africa and the rest of the southern African region are in the context of HIV treatment and prevention strategies,” writes Mark in his insightful post about South Africa and the HIV epidemic.

July brought bad news: the drought in the Horn of Africa began, bringing the region into international focus as an estimated 11.6 million people struggled for basic nutrition and sanitation in the humanitarian crisis – experts have warned that this situation could have a serious effect on the health of people undergoing HIV treatment.

Prevention trials continued to stay in the news. The Partners PrEP study and the TDF2 Botswana study both showed that taking antiretrovirals can reduce the risk of HIV infection through sexual intercourse by 62-73 percent among heterosexual individuals and heterosexual couples.

As heartening news continued to pour in, the UK’s House of Lords Select Committee on HIV & AIDS gave us another reason to celebrate as they called for greater emphasis and funding toward prevention. “Prevention must be the key policy,” remarked Lord Fowler, chairman of the committee.

In the US, dollars-and-cents issues remained a key factor. “The entire HIV prevention and treatment landscape overall is also in a state of flux in the US … When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded,” explains Julie Davids (Director of National Advocacy and Mobilization at AIDS Foundation of Chicago, a Mapping Pathways partner organization) in The Economic Effect: HIV/AIDS in the US.

October brought news that rekindled an old debate: the Lancet published the results of a study conducted in Africa, which seemed to suggest that hormonal methods of contraception could lead to increased risk of HIV infection. “Now whether this is a disaster or not, that needs to be considered very carefully in context. There are huge benefits, particularly in the African region, of avoiding an unwanted pregnancy, not only for the morbidity issues but also for mortality reasons … Firstly, we need to work out whether this result is true or not,” points out Dr. Tim Farley (an expert in HIV and sexual and reproductive health) in Hormonal Contraceptives and HIV Prevention: The Grey Area.

Recently, the VOICE trial hit a speed bump: the oral tenofovir arm and the tenofovir vaginal gel arm were dropped from the study. Both decisions were based on reviews of study data, which concluded that they would not be able to demonstrate effectiveness in preventing HIV among the women in the trial (although both products were found to be safe). The reasons for this are still unclear and will be fully investigated when the trial concludes in the middle of 20112. The study continues to examine the oral Truvada tablet to determine whether it’s effective in preventing HIV in the trial population.

A recent highlight was US Secretary of State Hillary Clinton’s speech on HIV/AIDS – one that earned her both bouquets and brickbats from the HIV prevention community. On the upside, Secretary Clinton focused on scientific evidence and called for immediate action to take advantage of the “historic opportunity” to create an “AIDS-free generation.” Unfortunately, she completely omitted any reference to PrEP and rectal microbicides. The speech also failed to mention gay and MSM populations, two groups that are experiencing catastrophic rates of HIV globally.

The year wound up with IRMA’s rectal microbicide African strategy meeting and the big ICASA conference in Addis Ababa, Ethiopia in December. (Click here and here to read about some of the important developments at these events.)

All in all, 2011 has been a dynamic year: lots of excellent news as well as some troubling developments. From the Mapping Pathways blog team, here’s to celebrating our achievements, learning from our failures, and working to address the challenges.

Happy New Year!

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

Mapping Pathways presents two posters at ICASA 2011 in Addis Ababa

Original content from our Mapping Pathways blog team

On December 5 Molly Morgan Jones and Jim Pickett from the Mapping Pathways project (left, top picture) presented two posters on our findings at the ICASA 2011 conference taking place now (through December 8) in Addis Ababa, Ethiopia.

The world has made great progress in fighting HIV/AIDS since the late 1990s. While incidence rates in sub-Saharan Africa have fallen, most of the world's new infections still occur there. A portfolio of approaches – or 'pathways' – to prevention is needed. Recent trial data shows great promise in four antiretroviral (ARV) prevention strategies.

The Mapping Pathways project used four separate methodologies to access diverse stakeholder perspectives and assess the evidence base, looking specifically at South Africa, India and the USA. 

We employ an adaptive approach to policy development around ARV-based prevention strategies. The project has engaged various stakeholders from India, South Africa and the United States in surveys, interviews and iterative exchanges to understand local perspectives and the empirical evidence needed to develop appropriate policy pathways for different contexts.

What will these pathways look like, how do we navigate them and where will they lead?

Please check out our posters - below - to learn more. And let us know what you think. You may leave a comment here, or send us an email at mappingpathways@gmail.com.

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

Mapping Pathways to Prevention

via AIDS Foundation of Chicago, by Gregory Trotter

There are many people talking about PrEP (pre-exposure prophylaxis) in the HIV/AIDS community. Some are all for it, others not so much.

“The conversations are happening but not in any focused way,” said Jessica Terlikowski, director of regional organizing for the AIDS Foundation of Chicago and AIDS United.

That’s the gap that Mapping Pathways intends to fill. The two-year multinational study is researching the efficacy and varied perceptions of oral PrEP, equally alongside other antiretroviral (ARV) prevention methods, such as testing and linkage to care plus treatment (TLC+), post-exposure prophylaxis (PEP), and vaginal and rectal microbicides.

At USCA on Thursday, Terlikowski and AIDS United’s Bill McColl presented early results of a 500-person survey on attitudes toward the various prevention methods.  It’s too early to draw conclusions from the data, Terlikowski said, but the study could ultimately be a difference maker. The HIV/AIDS epidemic is not identical from country to country and a one-size-fits-all prevention strategy is unlikely to work everywhere.

“This is about thinking about the full range of prevention tools and creating a space for community dialogue. … Mapping Pathways is not about promoting one strategy over another,” Terlikowski said.

The survey began in May and reflected perspectives from the United States, India and South Africa.
One interesting piece of data was nearly half of survey respondents felt that oral PrEP was very important – but an almost equal number had concerns.
In contrast, about 70 percent said they favored the use of microbicides.

Read the rest.


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

Aurobindo Pharma uses patent pool for generic AIDS drugs

via Reuters, by Ben Hirschler and David Holmes

India's Aurobindo Pharma has become the first major generic drugmaker to join a patent pool designed to make HIV/AIDS treatments more widely available to the poor, paving the way for it to sell cheap medicines in many countries.

The Medicines Patent Pool said on Tuesday the agreement would allow Aurobindo to make a range of AIDS drugs licensed to the pool by Gilead Sciences, the leading maker of HIV drugs, in July.

Aurobindo has also elected to take advantage of a key provision in the pool's licenses in order to sell one drug, tenofovir, to a wide range of countries without paying royalties. These could include several middle-income countries such as Argentina, Brazil, Chile, Colombia, Malaysia, the Philippines, Ukraine and Uruguay.

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Most live in Africa and Asia, where medicines have to be very cheap to allow those who need them to be able to afford them.

The Medicines Patent Pool, launched by the UNITAID health financing system that is funded by a tax on airline tickets, aims to address the problem by creating a system for patent holders to license technology to makers of cheap generics.


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

Gates Foundation’s AIDS Program in India Has Made Uneven Progress Over 8 Years

via The New York Times, by Donald G. McNeil, Jr.

A large and costly AIDS prevention program that the Bill and Melinda Gates Foundation pioneered in India eight years ago has had mixed results, according to a preliminary analysis published on Monday in The Lancet.

 

The foundation spent $258 million on the program from 2003 to 2008. It has since put in $80 million more, but is shifting responsibility to the Indian government.

The program, called Avahan, focuses on high-risk groups, like drug addicts, gay and bisexual men, and prostitutes and their clients, including truckers. It pays for education campaigns, safe-sex counseling, syringes, condoms and treatment for other venereal diseases. (Above, a sex worker at a prevention meeting.)

When the program began, it was assumed that India, with its huge population and government officials reluctant to discuss the problem, would quickly surpass South Africa as the country with the most AIDS cases. A 2007 household survey allayed those fears; the epidemic had stayed largely within the risk groups. India is now thought to be in third place, behind Nigeria.

Read the rest.


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

MSM in South India

via Deccan Herald, by Kalyan Ray

In what can emerge as a fresh public health challenge, literate young men in southern India are increasingly getting involved in high-risk activity of having sex with men without protection, making them vulnerable to HIV/AIDS. 

Though there is barely any reliable statistics available on the MSM (Men having Sex with Men) prevalence, as many as 8,615 members of the MSM community were interviewed in a new behavioural survey carried out in 15 districts of Andhra Pradesh, Karnataka, Maharashtra and Tamil Nadu.

In majority of the districts, HIV prevalence ranged from 5 to 30 per cent among high risk men while prevalence of other sexual diseases in the same community vary from 2 to 20 per cent.

The researchers claimed that actual numbers of the MSM population could be more because it was “representative sample”, which means only about 700 MSM people from each districts were interviewed for the study conducted between 2006 and 2010. The scientists took care to ensure that the same person is not interviewed twice.

Read the rest.


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

An integrated structural intervention to reduce vulnerability to HIV and sexually transmitted infections among female sex workers in Karnataka state, south India

via BMC Public Health, by Vandana Gurnani, Tara S Beattie, Parinita Bhattacharjee , Cfar Team, H L Mohan , Srinath Maddur, Reynold Washington, Shajy Isac, B M Ramesh, Stephen Moses and James F Blanchard

Abstract

Background:

Structural factors are known to affect individual risk and vulnerability to HIV. In the context of an HIV prevention programme for over 60,000 female sex workers (FSWs) in south India, we developed structural interventions involving policy makers, secondary stakeholders (police, government officials, lawyers, media) and primary stakeholders (FSWs themselves). The purpose of the interventions was to address context-specific factors (social inequity, violence and harassment, and stigma and discrimination) contributing to HIV vulnerability. We advocated with government authorities for HIV/AIDS as an economic, social and developmental issue, and solicited political leadership to embed HIV/AIDS issues throughout governmental programmes. We mobilised FSWs and appraised them of their legal rights, and worked with FSWs and people with HIV/AIDS to implement sensitization and awareness training for more than 175 government officials, 13,500 police and 950 journalists.

Methods:

Standardised, routine programme monitoring indicators on service provision, service uptake, and community activities were collected monthly from 18 districts in Karnataka between 2007 and 2009. Daily tracking of news articles concerning HIV/AIDS and FSWs was undertaken manually in selected districts between 2005 and 2008.

Results:

The HIV prevention programme is now operating at scale, with over 60,000 FSWs regularly contacted by peer educators, and over 17,000 FSWs accessing project services for sexually transmitted infections monthly. FSW membership in community-based organisations has increased from 8,000 to 37,000, and over 46,000 FSWs have now been referred for government-sponsored social entitlements. FSWs were supported to redress >90% of the 4,600 reported incidents of violence and harassment reported between 2007-2009, and monitoring of news stories has shown a 50% increase in the number of positive media reports on HIV/AIDS and FSWs.

Conclusions:

Stigma, discrimination, violence, harassment and social equity issues are critical concerns of FSWs. This report demonstrates that it is possible to address these broader structural factors as part of large-scale HIV prevention programming. Although assessing the impact of the various components of a structural intervention on reducing HIV vulnerability is difficult, addressing the broader structural factors contributing to FSW vulnerability is critical to enable these vulnerable women to become sufficiently empowered to adopt the safer sexual behaviours which are required to respond effectively to the HIV epidemic.


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

Mapping Pathways India: What We’re Hearing so Far

“Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” ~ Indian Activist

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.” ~ Indian PhD and Consultant

An important part of our project is to really learn what people think and feel about PrEP, not just through academic streams and studies but also through everyday wisdom and experience. 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? Do they feel it can be a useful prevention tool in their country? Would they use it or prescribe it?

The Mapping Pathways online survey and in-depth stakeholder interviews are important ways for us to gain knowledge on these questions. Both are well underway, and already we’re hearing some interesting observations and ideas. Of course, this data is still preliminary but we thought we’d share some snapshots of what we’re hearing from Indian doctors, policymakers, and activists on the ground.

Some of the overall concerns about PrEP that we’re finding in India as well as the other countries are questions about how these strategies will be rolled out and made accessible and affordable. There is also worry that other preventions strategies such a condom promotion will be neglected and unintended consequences, like an increase in risky behavior, might occur. Many of the individuals we’re speaking with want to see more evidence on these strategies, and there are huge concerns about resistance to ARVs and their safety.

One Indian respondent said, “At the moment not even all the HIV infected people needing ARV's are receiving it and adding more numbers to these will only strain the healthcare system in the country more.” Another observed, “PrEP seems to negate moral changes that need to be made within society which is the only ultimate ‘cure.’”

When some of the respondents were asked what types of information they’d like Mapping Pathways to provide to help them when considering PrEP as a strategy for their country, there was real curiosity about finding out how acceptable the strategy is for people living with or at risk for HIV; data on the real cost and cost effectiveness, and more information on clinical trial results; and how to translate all this knowledge into behavior changes.

Other comments and observations so far include:

“It is an assumption that MSM and sex workers are at high risk of getting HIV/AIDS, but women in monogamous relationships are also at high risk.  Nobody can be excluded completely from being at risk.” – Indian politician and policy maker

“It is important to invest in a range of prevention efforts, not simply switching focus from one to another.  Individuals should have a right to choose how they want to protect themselves, and different tools for prevention should be made available.” – Indian activist and HIV consultant

“Global funding for HIV is shrinking, and if a person starts ARVs there is a cost to keeping them on ARVs.” – Indian PhD and consultant

“Oral prevention is an irresponsible approach that would hurt overall prevention efforts.  The HIV epidemic has forced the promotion for overall safe behavior, especially condom promotion and family planning.  These are integral not just for HIV prevention, but for general public health in India.”– Indian PhD and consultant

“From a women’s perspective any prevention tool that gives an individual control over preventing infection is important ...PrEP is a way for a person to take responsibility for their own health.” – Indian activist and HIV consultant

“There is an economic impact that the government needs to acknowledge.  Appropriate funding needs to be allocated to secondary care.” – Indian doctor

For some more insights on Indian reactions toward PrEP and HIV prevention, read our blog posts Notes from India: Concerns and Challenges Around PrEP and A Modern Day HIV Love Story.

We also encourage all Indian citizens who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!
 
Take the survey now.

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