A Modern Day HIV Love Story

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Dr. Suniti Solomon, a veteran in the HIV/AIDS prevention field and one of the doctors credited with diagnosing the first case of HIV infection in India in 1986, recently took a special interest in an unconventional Indian wedding. The bride was from Delhi and the groom from the South – but it was not the unconventionality of this North/South love story (in an otherwise highly caste-conscious Indian society) that made this wedding special to Dr. Solomon. Unknown to most of the friends and family celebrating this happy occasion, the bride and the groom were both patients of Dr. Solomon’s – both of them HIV positive and under treatment[1] at her clinic, Y.R. Gaitonde Center for AIDS Research and Education (YRG CARE), in Chennai. In fact, Dr. Solomon introduced them earlier this year, and they fell in love almost instantly. Their love story is going to be featured in a documentary film called Match+: A Story About Love In The Time Of HIV. Learn more about the film here (scroll down and click on the tab titled “Match +”).

We caught up with Dr. Solomon (who is also known as “the HIV matchmaker” in some circles) and Ann Kim, one of the filmmakers behind the film, to learn more about this story, their views on HIV, and their thoughts on love.


MP: Please introduce yourselves and what you do.

Dr Solomon: I’m Dr. Suniti Solomon and I’m the director of Y.R. Gaitonde Center for AIDS Research and Education. I’ve been working with HIV right from the beginning for the last 25 years, doing prevention, care, and research work.

Ann: I’m a producer/journalist, focused mainly on global health as well as US health issues. My film partner Priya Giri Desai and I have been working on a film about Dr. Solomon for the last three years. 


MP: Dr. Solomon, you have been referred to as an HIV matchmaker by some. How did that come about?

Dr Solomon: 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. It so happened that the first young man who came to us was an engineer. We arranged a match for him with a girl in Maharashtra, and we told him to tell his parents that he fell in love with her when he went for a meeting in Bombay (which he used to do often for work). That’s how they got married, and now their families are happy. Both the boy and girl have kept their HIV-positive status only between themselves, it has not been disclosed to anyone else besides us.

 
MP: And how long have you been doing this?

Dr Solomon: The first match, they now have a child who is around 10, so we started about 10 years ago. And now we get a lot of inquiries. We get emails, we get people from Canada and Australia writing to us saying they want to get married.


MP: If you were to describe this documentary, what would you say is its message or what it’s about?

Dr Solomon: I would say the message is that HIV has become a chronic disease today, almost like diabetes or hypertension. People think if you’re HIV-positive, that’s it – now you sit in the corner of the room. But that’s not the case anymore. With the correct treatment, you can still continue to work, to live, to get married, to have children – if you want to. And in India, culturally, it is so important to get married and have children.

Ann: I would say it’s also about Dr. Solomon. She’s a pioneer in her field, and she’s a remarkable person who has lived an unconventional life. I’ve learnt a lot by watching her work, especially in the face of stigma not only to her patients, but also potentially to herself. This documentary also explores what Dr. Solomon touched upon – in India, where the expectation is that you get married, how do you handle that when you’re living with HIV? How do you satisfy these cultural expectations as well as your own hopes of finding a partner and companionship if you have this issue that you can’t even talk about? For many HIV-positive people here, if somebody finds out about their status, they could lose their jobs, they could get kicked out of their communities, their homes, their families… This was something that, for both myself and my film partner Priya, was really compelling to explore and bring to light.

 
MP: You both alluded to the documentary also being a modern love story.

Ann: Yeah, I think so…

Dr Solomon: Yes… but in reverse. Although marriages are made in heaven, we make them happen at our center – sometimes, we arrange the marriage first and then the couple falls in love. We have a boy and girl who were recently married at the center. They are so in love – she can’t wait for her husband to come back from work each evening. During their courtship, they would both sms each other every night, reminding the other to take their respective pills. And now that they are married, they take their pills together in the evening.[2]


MP: And how did they get infected?

Dr. Solomon: The boy had a blood transfusion. And the girl got it from her first husband, which was an arranged marriage.


MP: That’s exactly what you try to prevent by doing this matchmaking.

Dr. Solomon: Exactly.


MP: Ann, you and Priya have been on this journey for the past three years, traveling between continents, relying on grants as well as your own personal funds… Why does this documentary matter to you so much?

Ann: Well…

Dr Solomon: Because she’s not married (whispers). That’s why she’s so interested. Once you get married, you settle down in life, you don’t think of all this.

Ann: (Laughing) Well… At the end of the day it’s really about getting these unknown stories told. While MATCH+ is about the lives of a handful of HIV-positive individuals searching for companionship in a particular social context, the themes are universal. And, ultimately, very human. I think there is much to be learned from them. Besides, who doesn’t like a love story?

Match+: A Story About Love In The Time Of HIV is currently in final production. In order to protect the identity and wishes of the people participating in the documentary, names have been changed and faces obscured at the request of participants. You can read more about the film here (scroll to the bottom and click on the tab titled “Match+”).

---

[1] Dr. Solomon’s HIV+ patients are given an antiretroviral (ARV) regime as a way of managing their disease, an approach that she and other HIV/AIDS specialists have been following and advocating for many years. The approach, which is known as TLC+, stands for Testing, Linkage to Care, plus Treatment. The strategy includes voluntary counseling and HIV testing with a direct link to care and treatment (taking antiretroviral medications) for those who test HIV+.

[2] Dr. Solomon is referring to the antiretroviral (ARV) regime her clinic prescribes to HIV+ patients as a way of managing their disease.



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

HIV Surveillance, Public Health, and Clinical Medicine — Will the Walls Come Tumbling Down?

Perspective by Amy L. Fairchild, Ph.D., M.P.H., and Ronald Bayer, Ph.D. via New England Journal of Medicine

The centrality of antiretroviral therapy for people with human immunodeficiency virus (HIV) infection is an established feature of the clinical response to HIV–AIDS. Now there is compelling evidence that such treatment can have a profound impact at the population level by reducing viral loads and hence infectivity.1 As a consequence, important ethical and operational questions about the relationship between clinical medicine and public health are surfacing. Perhaps the most fundamental of these centers on the uses of surveillance.

More than two decades of battles over HIV surveillance yielded a comprehensive public health surveillance system — along with robust firewalls to protect confidentiality. Many surveillance personnel and advocates for people with HIV asserted that such registries should be used for epidemiologic purposes only — that data should go in but not come out.

Despite such deep resistance, pressure began to mount to ensure that surveillance data were used to serve public health ends. In 2007, a report from the Centers for Disease Control and Prevention (CDC) bluntly stated that “once the data are in hand it is the failure to use those data for public health purposes that must be justified.”

Read the rest.


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

AIDS stalks gay and transgender Indians

via AFP

India's success in slashing HIV/AIDS infection rates by 50 percent in the last decade masks a high rate of infection among homosexual and transgender people, experts say.

This anomaly was highlighted last month by the country's Health Minister Ghulam Nabi Azad in a now notorious speech at an AIDS conference that will be remembered for other reasons.

Azad went on to call homosexuality "a disease which has come from other countries" and "unnatural", in comments widely condemned by gay rights activists and AIDS workers.

At the Pahal Foundation in the northern state of Haryana, which provides free HIV tests, condoms and counselling services to gay and transgender people, project manager Maksoom Ali says he faces a constant battle against ignorance. Most gay men, fearing homophobia, are forced to hide their sexual activity, and others have no idea about the dangers of unprotected intercourse, he said.

"Many people think that men having sex with men cannot get HIV and that's one reason why (homosexual and transgender) people have a lot of unsafe sex," Ali told AFP.

The country's National AIDS Control Organisation (NACO) estimates that 7.3 percent of India's homosexual population lives with HIV, compared with 0.31 percent of the total adult population.

The UN AIDS agency estimated that around a third of men who have sex with men in India fail to access services like HIV testing, sex education and free condom supplies.

Read the rest.

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

HIV Experts Create the Roadmap for Providing PrEP to Uninfected Individuals to Reduce the Risk of HIV Infection

Press release via Forum for Collaborative HIV Research

To stem the estimated 2.6 million new HIV infections that occur worldwide each year, more than 200 representatives from the scientific and HIV/AIDS communities took an important step in assessing the safety and public health implications of providing antiretroviral drugs to uninfected men and women exposed to HIV through sexual contact – a strategy called pre-exposure prophylaxis, or PrEP.

Assembling August 19 at an open public meeting and interactive webcast convened by the Forum for Collaborative HIV Research, these researchers, HIV/AIDS advocates, members of industry and representatives from National Institutes of Health, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and state public health departments applied the findings from a number of large trials to discuss a roadmap for FDA and CDC to develop guidance on the safe use of PrEP in otherwise healthy individuals at high risk of acquiring HIV. Held with the encouragement of FDA, this meeting has important implications for medical practice in the U.S. because recent data strongly support the efficacy of antiretroviral intervention for this purpose.

Although FDA has not yet approved PrEP to reduce HIV acquisition in uninfected individuals, one form of PrEP recently studied for use in healthy men or in couples where one partner is HIV positive –a daily pill containing tenofovir plus emtricitabine (TDF/FTC) – is FDA-approved for the treatment of HIV infection. In women, studies have also demonstrated the efficacy of prophylactic treatment with tenofovir applied as a vaginal gel.

“We now have findings from large studies that support a conclusion that PrEP is effective in gay and bisexual men, who represent more than half of new HIV infections in the U.S., and now, there is evidence that PrEP may reduce HIV infection in heterosexual men and women, the population hardest hit by HIV worldwide,” said Jur Strobos, MD, Deputy Director of the Forum. “We must however, apply these promising data to develop workable strategies that mitigate risk that may be associated with the prophylactic use of antiretrovirals. These include both medical and socio-behavioral risk. We must ensure that people at greatest risk for acquiring HIV receive a comprehensive package of prevention services, including regular HIV testing, condom provision, risk reduction counseling and management of other sexually transmitted infections. The purpose of our meeting was to help identify what the components of a complete package should be.”

Read the rest.

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

Safe-Sex Education: Too little, too much?

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

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

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


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

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


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

Mapping Pathways at the CDC's National HIV Prevention Conference

via AIDS United (a Mapping Pathways partner), by Jessica Terlikowski

Clinical trial results over the last year have demonstrated that new prevention approaches such as ARV-based microbicides, pre-exposure prophylaxis (PrEP), and expanded treatment of people living with HIV can significantly reduce a person’s risk of contracting or transmitting HIV. The findings give the HIV community new hope, but also raise new and critical questions of how, if, where, when, and to whom these new strategies will be made available.

To ensure sound decisions that best address the epidemic, being careful to preserve human rights and improve the health of those living with and at risk to HIV, AIDS United, AIDS Foundation of Chicago, Desmond Tutu HIV Foundation, and NAZ India are asking a number of questions regarding the multiple uses of ARVs for prevention. People living with HIV/AIDS (PLWHA), policymakers, government officials, advocates, clinicians, researchers, industry experts, and other stakeholders have important perspectives to share and must be at the table to discuss the complexities of these new strategies. This collective effort to create and support a research-driven, community-led global understanding of the emerging evidence around adoption of ARV-based prevention strategies is Mapping Pathways.

As part of this unique project, AIDS United and the AIDS Foundation of Chicago hosted a lively community input session at the National HIV Prevention Conference last week to learn what HIV prevention leaders think about implementing the diverse range of ARV-based prevention tools. The group generally agreed that we are in an exciting time, but also questioned how the HIV community and the U.S. government could even consider implementing a strategy that provides medications to HIV-negative people when tens of thousands of people with HIV in the U.S. cannot access the drugs they need to stay healthy. Various participants also noted that not all PLWHA are ready to start treatment. Some individuals expressed concern that the rights of PLWHA could be compromised in favor of the public’s health and stated that systems must be instituted to mitigate coercion and protect the rights of the individual. Advocates were equally concerned that interventions such as PrEP would only succeed in worsening HIV-related health disparities in the U.S. since the cost is so great, treatment access is already limited, and both state and federal governments continue to cut HIV programs. One advocate observed that the ARV-focused discussion has resulted in the marginalization of other bio-medical strategies including vaccines and non-ARV based microbicides.

We also asked participants to share their thoughts on the types of data, tools, and information they believe are needed to help answer the more complicated questions and better address the community’s concerns. Several suggestions were made, but common to all of them was a request that tools be simple, accessible, and useful for community stakeholders and decision makers, including:

• Simple factsheets explaining the various ARV strategies, how they work, and the outcomes of each of the clinical trials;
  
• An if-then tool to help stakeholders better understand the potential implications of trial results; and
  
• A voice of the community document that includes statements from diverse individuals explaining why access to a broad range of HIV preventions, including those that are ARV-based, are important.

AIDS United and its partners look forward to continuing these conversations with our stakeholders around the country. You can stay connected to Mapping Pathways and all the latest ARV-based prevention news through our blog, Facebook, and Twitter. We invite you to join the dialogue and contribute YOUR thoughts by taking the Mapping Pathways survey.




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

What Happens When the "Placebo Window" Closes?

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

MP: Why do we have placebo-controlled trials?

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

MP: What do we learn by including placebos? 

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

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

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

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

Read more »

Lancet Editorial: Treatment as Prevention for HIV

 via The Lancet Infectious Diseases

SNIP> The findings of these studies are certainly encouraging and the addition of antiretroviral drugs to the armamentarium of approaches to prevent the transmission of HIV is to be welcomed. The past 30 years have shown that reductions in HIV transmission and the burden of AIDS rely on a combination of approaches that need to be tailored, adapted, and selected on the basis of the specific situations and populations. Already, successful treatment to control viral load is helping to prevent transmission, and the role of antiretrovirals will grow as the results of the new trials inform future programmes.

 

Enthusiasm generated by these results must be tempered with caution. A shortfall exists in access to antiretroviral drugs for populations in need of treatment to prolong their lives. In the face of the current global economic situation, how can these drugs be provided as prevention to those high-risk populations, while people with the disease in need of treatment continue to go without?

 

Expanding the use of antiretrovirals to include pre-exposure prophylaxis will increase the risk of resistance, which is already a serious problem. HIV is a rapidly evolving virus and development of resistance creates the need for ever changing regimens of drugs in various classes. The current dire situation with antibiotics should serve as a lesson to initiatives seeking to increase the ways in which we use antiretroviral drugs.

 

Furthermore, although some of the trial results have been very impressive, the protection with pre-exposure prophylaxis is unlikely to be 100%, and making drugs available as prophylaxis could encourage high-risk sexual behaviour among those who believe themselves to be protected.

 

Integration of antiretroviral prophylaxis into HIV prevention strategies must not be at the expense of tried and tested behavioural interventions, and care must be taken to safeguard the usefulness of these drugs for treatment in the future and to encourage a healthy drug-development pipeline. The fight against HIV/AIDS is a long-game, and current enthusiasm for positive results must lead to approaches that are sustainable in the long-term.

Read the rest.

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

From iPrEx to TDF2: A Quick Look at the Prevention Journey this Past Year

Starting in July 2010, encouraging results from a number of HIV prevention studies have revolutionized the HIV prevention landscape over this past year – from using oral PrEP and microbicides among HIV-negative people to reduce the risk of infection, to providing early antiretroviral treatment to people with HIV to reduce the risk of transmitting the infection to their uninfected partners.

Here is a quick look at six of the most significant trials: CAPRISA 004, iPrEx, FEM-PrEP, HPTN 052, Partners, and TDF2 that, together, are radically changing the way we look at prevention.

July 2010: CAPRISA 004 – a microbicide study

Background: Conducted by the Centre for the AIDS Programme of Research in South Africa (CAPRISA), Family Health International (FHI), and CONRAD. Funded by the United States Agency for International Development (USAID) and Technology Innovation Agency (TIA).

Who: 889 sexually active women.

Where: South Africa.

What: 1% tenofovir vaginal gel, applied within 12 hours before and after sexual intercourse.

Key results: The microbicide provided 39% protection from HIV acquisition. In women who used the gel more than 80% of the time, there was 54% efficacy. The gel also halved the women’s risk of acquiring HSV-2, the virus that causes genital herpes and also increases the risk of contracting HIV.

To know more about this study, click here and here.

November 2010: iPrEx – a large-scale, Phase III PrEP study

Background:Funded by the U.S. National Institutes of Health (NIH) through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California at San Francisco (UCSF). Additional funding provided by the Bill & Melinda Gates Foundation.

Who: 2,499 men who have sex with men and transgender women who have sex with men.

Where: Peru, Ecuador, South Africa, Brazil, Thailand and the US.

What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as monthly HIV testing and risk-reduction counseling.

Key results: PrEP provided 42-44% protection from HIV acquisition. The protective effect was even higher among those with good pill adherence. According to the initial findings, with 50% adherence reported, the efficacy was 50%; with 90% adherence reported, there was 73% efficacy. Updated findings were presented at the International AIDS Society conference in Rome: the drug had 92% efficacious in preventing HIV infection amongst those who had detectable drug levels; overall efficacy was 42%.

To know more about this study, click here and here.

April 2011: FEM-PrEP – a Phase III PrEP study

Background: Implemented by Family Health International (FHI) in partnership with research centers in Africa. Funded by the United States Agency for International Development (USAID), with early funding from the Bill & Melinda Gates Foundation.

Who: 1,951 sexually active women.

Where: Kenya, South Africa, and Tanzania.

What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as HIV testing and counseling.

Key results: The interim FEM‐PrEP study results were inconclusive. As determined by a preliminary data review, the study would not have been able to demonstrate whether or not Truvada was effective in preventing HIV in women in this study. FHI, therefore, decided to close the trial early due to futility.

To know more about this study, click here and here.

May 2011: HPTN 052 – a Phase III antiretroviral study

Background:Conducted by the HIV Prevention Trials Network (HPTN). Funded by the National Institute for Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH). Additional support provided by the NIAID-funded Adult Clinical Trials Group.

Who: 1,763HIV serodiscordant couples, in which the HIV-infected partner had a CD4+ cell count of 350-550 cells/mm^3.

Where: Botswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, United States and Zimbabwe.

What: Initiation of early antiretroviral treatment, as well as regular counseling.

Key results:The interim review showed that antiretroviral treatment reduced the risk of HIV transmission from treated partner to uninfected partner by 96%.

To know more about this study, click here and here.

July 2011: Partners – a Phase III PrEP study

Background: Funded by the Bill & Melinda Gates Foundation.  The University of Washington International Clinical Research Center is the study sponsor and coordinated the trial in collaboration with investigators at the study sites.

Who: 4,758 heterosexual African HIV serodiscordant couples, that is, in which one partner had HIV and the other did not. 

Where: Kenya and Uganda.

What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate) or tenofovir (oral TDF), as well as HIV testing and counseling.

Key results: The risk of infection was reduced by 73% in those who received Truvada, and by 62% in those who received tenofovir alone. Adherence was extremely high: more than 97% of doses dispensed were taken, and 95% of participants stayed in the study.

To know more about this study, click here and here.

July 2011: TDF2 – a PrEP study

Background: Conducted by BOTUSA, a partnership between the Botswana Ministry of Health and the US Centers for Disease Control and Prevention.

Who: 1,200 sexually active men and women.

Where: Botswana.

What: Once-daily does of Truvada (oral FTC-TDF – emtricitabine and tenofovirdisoproxilfumarate), as well as HIV testing and counseling.

Key results: In the primary analysis, it was seen that Truvada reduced the risk of infection by 63%. In the secondary analysis, excluding infections that occurred amongst people who had run out of their Truvada pills and had not taken one for at least 30 days, there was 78% efficacy.

To know more about this study, click here and here.

To stay abreast of research into new prevention technologies, check out AVAC and IRMA.

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

Human behaviour complicates prophylactic measures

Public-health workers in Thika, Kenya,

perform a skit to advertise a prophylactic

HIV drug trial

Via Nature News, by Erika Check Hayden.

When the US Food and Drug Administration approved Viagra in 1998, officials never considered one possible side effect of the drug: higher rates of sexually transmitted diseases among men who, thanks to Viagra, would become more sexually active. A powerful tool in the fight against HIV is raising similar questions about the possibility of unintended public-health consequences if drugs are approved for use in healthy people and cause them to alter their behaviour.

Several studies in the past year have reported that the very drugs used to treat people with HIV can also stop healthy people from becoming infected (see table). But people taking the drugs may adopt riskier behaviours because they feel protected — a phenomenon known as 'risk disinhibition' — undermining the benefit of the drugs and potentially infecting others. Moreover, those who become infected while taking the preventive regimen might develop drug-resistant viruses that they could then transmit to others. "You have this wonderful scientific breakthrough," says Kevin Frost, chief executive of the Foundation for AIDS Research in New York City. "But what are the practical implications?"

Researchers will mull over these issues on 19 August at a meeting convened by the Forum for Collaborative HIV Research in Washington DC. The questions have become more urgent since January, when the drug firm Gilead of Foster City, California, announced that it plans this year to ask the Food and Drug Administration (FDA) to approve its HIV drug Truvada for use in healthy people — in what is known as pre-exposure prophylaxis, or PrEP. Truvada, which contains the antiretroviral drugs tenofovir and emtricitabine, has been used in many of the PrEP trials. In the three clinical trials that have reported benefits for PrEP so far, once-a-day pills have cut a person's risk of acquiring HIV by between 44% and 73%, a variation that is due primarily to differences in how strictly patients stuck to the daily regimen. Although the need for PrEP is greatest in poor countries, approval in the United States could greatly expand the market for Truvada, which generated US$2.65 billion in sales last year.

Read the rest here.

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

Kaiser/UNAIDS study finds drop in overall disbursements for AIDS response in 2010, seven out of 15 governments report reductions

Via the Kaiser Family Foundation.

Funding disbursements from donor governments for the AIDS response in low- and middle-income countries fell in 2010, dropping 10% from the previous year’s level, according to an annual funding analysis conducted by the Kaiser Family Foundation and the Joint United Nations Programme on HIV/AIDS (UNAIDS).

The study found that donor governments disbursed US$ 6.9 billion in 2010 for HIV prevention, treatment, care and support--US$ 740 million less than in 2009. The decrease was due to a combination of three main factors: actual reductions in development assistance, currency exchange fluctuations, and a slowdown in the pace of U.S. disbursements, which was not a budget cut.

Of the 15 governments surveyed, seven--Australia, Germany, the Netherlands, Norway, Spain, Sweden and the United States--reported a year over year decrease in their disbursements as measured in their own currencies. The figures presented in the report are in US dollars, consistent with international standards and other reporting mechanisms.

Due to currency fluctuations, when measured in US dollars, Australia showed a slight increase in its AIDS funding contribution even though it contributed less in its own currency. Conversely, there was a slight decrease in Denmark’s contribution despite the country’s increased funding level in its own currency.

"AIDS is a smart investment even in this difficult economic environment. We have to look beyond the near-term costs and recognize the long-term benefits," said Michel Sidibé, Executive Director of UNAIDS. "Donors need to make and follow through on commitments today to reduce costs in the future."

The overall drop in disbursements was primarily attributed to a reduction in disbursements by the United States, the largest donor nation, which accounted for 54% of total donor disbursements in 2010. While the United States Congress appropriated similar levels of funding for the AIDS response in 2010 as in 2009 (approximately US$ 5.5 billion in each year), disbursements from the United States declined from US$ 4.4 billion in 2009 to US$ 3.7 billion in 2010. This slowdown stems from new requirements established by Congress for the United States President’s Emergency Plan for AIDS Relief (PEPFAR). Some funds appropriated in 2010 will be disbursed in later years.

"With U.S. funding delayed but not eliminated to this point, this year’s drop in spending may be a temporary blip, though its impact on services may be real," said Drew Altman, Kaiser Family Foundation President and CEO.

Read the rest here.

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

Tricky Terminology in HIV Prevention: "Abstinence" and "Being Faithful"

In the HIV/AIDS prevention world, terminology can be a tricky thing. Over time, certain words have taken on different implications and nuances across various communities.

Take “abstinence” and “being faithful” – two conventional HIV-prevention methods that have been the subject of a long-running debate in the public health community. These terms were at the forefront of discussion once again last month, sparked off by NAM’s new HIV prevention resource where they were at the top of the non-alphabetical list of HIV-prevention methods. NAM swiftly clarified that the order was the same as in previous printed editions, with newer sections being added in later. An organizational representative emphasized that NAM has tried to capture the pros, cons, and complexities of each prevention method and that the organization stays away from editorializing.

The debate, however, continues. Many see “abstinence” and “being faithful” as loaded with sexual morality, inextricably tangled up with conservative ideas of virtue and marriage, and reinforcing social taboos against pre-marital sex and polygamous relationships. On the other hand, in many patriarchal cultures, postponing sexual activity can actually be seen as empowering for women who are often pressurized into early sex. Similarly, remaining unmarried is not a realistic choicefor women in many countries – in such a context, reducing unsafe sex with multiple, concurrent partners would be an important aspect of HIV prevention.

A great step would be promoting the usage of alternative terms that focus on behavior rather than “values”. For instance, why not replace “being faithful” with a more neutral phrase, one that brings open, honest non-monogamous relationships within its ambit? Unfortunately, “monogamy” seems to have supporters and detractors in equally large numbers, and the same goes for “mutual fidelity”. While some see these options as objective behavioral descriptors, others perceive them as morally loaded phrases. It seems almost impossible to come up with a term that works for everyone – this is perhaps inevitable considering the widespread geographic and cultural differences within the HIV prevention community!

Of course, many people in the HIV prevention field question the very effectiveness of both these measures, making the debate even more heated. Abstinence is commonly perceived as a “failed” method, and being faithful/monogamy/mutual fidelity seems like a non-option when being married is often an independent HIV risk factor for women in many communities (conversely,others point out that the latter takes place precisely because the women’s husbands may have multiple,concurrent relationships).

The majority point of view, however, seems to be that no single option is equally valid for every person, community, or country. Offering these conventional prevention methods as part of a bouquet is valuable: they can work for people who are ready, prepared, and happy to use them consistently (like any other prevention option).

Coming soon: another “Tricky Terminology” post on the important distinction between “oral PrEP” and “microbicides” in HIV prevention discourse.

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

PrEP acceptable to gay men and few report that it would change their risk behaviour

via aidsmap, by Michael Carter.

Approximately 50% of gay men said they were likely to use pre-exposure prophylaxis (PrEP), but few reported that it would lead to a change in their risk behaviour, according to data presented to the International AIDS Society conference in Rome.

Nevertheless, the investigators were concerned that even minor increases in rates of unprotected anal sex could offset the benefits of pre-exposure prophylaxis.

The IPrEX study showed that PrEP significantly reduced the risk of infection with HIV for gay and bisexual men. Overall, men who took PrEP had their risk of HIV reduced by 44%. If adherence was high, the risk was reduced by 73%.

“PrEP offers much promise as the first biomedical intervention to have success in at-risk men who have sex with men,” comment the researchers.

They therefore undertook further analysis to see how likely the men who participated in the study were to use PrEP and if its availability would change their HIV risk behaviour.

They undertook a survey in December 2010, immediately following the release of the IPrEX results, using Facebook and Black Gay Chat to recruit participants. A total of 1155 gay and other men who have sex with men were recruited to the study.

Participants completed a questionnaire about their knowledge and willingness to use PrEP; perceptions of the risk of HIV infection from unprotected anal sex with or without PrEP; perceptions of sexual pleasure; and perception of likelihood to experience sexual pleasure with or without a condom and with or without PrEP.

The men had an average age of 33 years, 75% were white, and 51% reported unprotected anal sex at least once in the last twelve months.

Only a third of men had heard of PrEP before the release of the study results. Just under half of individuals reported that they were “very” or “extremely” likely to use PrEP.

Unprotected anal sex without a condom was widely considered to involve a high risk of HIV.

The availability of PrEP did not alter the perception of the risk associated with HIV in the majority of men, regardless of whether they were the insertive (75%) or receptive (60%) partner in anal sex.

Three-quarters of men stated that the 44% efficacy of PrEP in the IPrEX study would not affect their use of condoms. However, 7% reported that they would use condoms less frequently.

Read the rest here.

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

Notes from India: Concerns and Challenges Around PrEP

At present, India has approximately 2.4 million people living with HIV out of its total population of approximately 1,210 million people (a prevalence of 0.03%). In 2009, close to 1.2 million people were newly infected. According to a recent United Nations report, there has been a 50 percent decline in the number of new HIV infections in the country over the last decade.

India has made significant strides in tackling HIV/AIDS in recent years, with the government’s efforts actively being supported by the Bill & Melinda Gates Foundation, the World Bank, and the United States Agency for International Development. Many Indian NGOs work to provide care facilities, ARV medicines and education for people living with HIV. There has also been consistent work towards spreading awareness, from communicating key messages though concerts, radio shows, and TV spots with famous Bollywood stars to innovative initiatives such as promoting condom use through kite flying during popular festivals.

However, much remains to be done. “Most importantly, the government needs to step in because we need better laws – laws that will enable behavior change and help us fight HIV effectively. There are some draconian laws that stigmatize sex workers and intravenous drug users, making life very unsafe for them. MSM community building is nearly impossible due to the hostile environment. Sex education also needs to be made legally mandatory in the school system. These steps would help bring about real change,” says Anjali Gopalan, Executive Director of NAZ India, a Mapping Pathways partner organization.

How is India responding to pre-exposure prophylaxis (PrEP)? Says Anjali, “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+.” There could be a few reasons for this view. First, India is a low-prevalence country, and people in the HIV prevention field believe this makes it very different from places like South Africa where the prevalence among the general population is very high. Second, there have been great difficulties in procuring ARV drugs for people living with HIV recently. “There are massive stockouts – the government is saying they don’t have the money to buy more drugs – we’re trying to move drugs from centers where they are less utilized to others where they are needed more. There is a lot of concern in the country, especially with global funding not available right now,” explains Anjali.

When it comes to PrEP, the common view in India (and elsewhere) appears to be that to take away dwindling funding and hard-to-get ARV drugs from HIV-positive people and directing them toward HIV-negative people is not a realistic or justifiable step. Of course, others are quick to point out that it is not a case of either/or – PrEP is simply one more new tool with which to prevent HIV infections. The public health community is still in the phase of gathering data on PrEP and figuring out the best possible way to utilize this new option in a variety of regions with different target populations.

Cultural differences may also play a part. For instance, homosexuality is still largely taboo in India and drug users are commonly seen as people who “knowingly put themselves at risk”. Discordant couples face a similar issue: No-one sees a problem with giving ARV drugs to people who are infected. But some doctors and social workers have indicated an aversion to giving drugs to those who are not infected on the assumption that they may indulge in high-risk behavior.

There are other significant questions for India, and for other countries contemplating whether they will implement PrEP or not: How does one ensure compliance among people who are healthy?  How does one ensure that side-effects, if any, are taken care of? How would one follow up? Will private practitioners be involved? India is still grappling with basic infrastructural and supply-chain issues, which makes these extremely important concerns.

“The Mapping Pathways team is trying to help answer these very questions,” says Jim Pickett, Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago, chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. “It’s time to gather all of this new data that’s pouring in and make sense of it, see how it can be applied in real scenarios. PrEP might make sense for some communities and situations, and it might not for others. Our end goal is to give decision-makers all the information they need to make informed decisions.”


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

Special Prevention Conference Session: Where Should ARV-based Strategies be on the HIV Prevention Map?

Special Mapping Pathways Input Session at the 2011 National HIV Prevention Conference in Atlanta: Where Should ARV-based Strategies be on the HIV Prevention Map?

The results of recent clinical trials demonstrate that anti-retroviral based prevention strategies hold great promise for ending the HIV epidemic, while simultaneously raising important and challenging questions for the HIV community.

A research-driven, community-led global understanding of the emerging evidence based around the adoption of ARV-based prevention strategies is essential to answering these questions and in deciding where, how, and if these strategies are on the prevention maps of cities, states, and/or countries.

Join AIDS United and the AIDS Foundation of Chicago- two members of the international Mapping Pathways team - at the 2011 National HIV Prevention Conference, Monday, August 15 5:30-7:00 p.m. in the Hyatt Regency Hotel Roswell Room, to share your perspectives and concerns in this facilitated open discussion and help map pathways to sound decision making.

SPACE IS LIMITED. Email zfellows1@aidsunited.org to RSVP and secure your spot.


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

Antiretroviral prevention methods 'not in competition' with each other

Via AIDSMap, by Keith Alcorn.

Antiretroviral prevention methods are not in competition, and policy makers and providers need to start to thinking about how antiretrovirals, pre-exposure prophylaxis and microbicides will be provided as part of a combination prevention package – and who will benefit most from each method, delegates heard at a satellite meeting on the opening day of the Sixth International AIDS Society Conference (IAS 2011) in Rome.

“You don’t want to have the family planning clinic here, the pills clinic here, the injections clinic here, and the microbicides clinic over here,“ said Dr Stephen Becker of the Bill and Melinda Gates Foundation.

Delegates were discussing the rapidly changing landscape of HIV prevention methods that use antiretroviral drugs. One year ago, at the International AIDS Conference in Vienna, the world heard the results of the CAPRISA study, which showed that a microbicide gel containing tenofovir halved the risk of HIV infection in women who used the vaginal gel consistently.

Since then results from four studies have added to the array of prevention methods that exploit antiretroviral drugs to prevent transmission or acquisition of HIV infection:

• The iPrEx study showed that taking the antiretroviral combination Truvada (tenofovir and emtricitabine (also known as FTC) reduced the risk of HIV infection in men who have sex with men by 44%.
• The HPTN 052 study showed that early treatment reduced the risk of HIV transmission to an uninfected regular partner by at least 96%.
• The Partners study showed pre-exposure prophylaxis with Truvada or with tenofovir alone reduced the risk of HIV infection by between 62% and 73%.
• The TDF2 study showed that  pre-exposure prophylaxis with Truvada reduced the risk of infection by between 62% and 78%.

The first tenofovir-containing microbicide could receive regulatory approval by the end of 2013, subject to positive results from a confirmatory trial now taking place in South Africa. That study is testing exactly the same dosing regimen as that used in the CAPRISA study, the so-called BAT 24 dosing schedule: one dose Before, one After, and no more than Two doses in 24 hours.

A second CAPRISA study (008) is testing the roll-out of tenofovir gel through family planning clinics in KwaZulu-Natal, comparing the monthly testing and follow-up schedule used in the original CAPRISA study with a three-monthly schedule, in order to examine the feasibility and acceptability of providing a microbicide through existing health services that target sexually active women.

Although the South African government has already begun investing in the scale-up of production facilities to manufacture the gel, the extent of demand for the microbicide is still unclear. Studies of women’s’ attitudes towards the microbicide will be needed to gauge demand, but a lot of work will also be needed to develop demand – and to make sure that women understand how they could benefit from using the microbicide.

“We need to reach out to women who don’t perceive themselves to be at risk, and we should be getting communities to rally round to be early adopters of tenofovir gel,” said Samu Dube of the Global Campaign for MIcrobicides.

“We need to get the product to the places where women are: the family planning clinics, the immunisation centres, antenatal clinics. We also need to target the school health system.”

However, work will also be needed to convince the providers of those services that they have a role to play in expanding women’s opportunities to protect themselves from HIV infection.

Read the rest here.

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

Safety Issues in PrEP: A Public Meeting

 You are invited to a public meeting with the Forum for Collaborative HIV Research in Washington D.C.:

Safety Issues in Pre-exposure Prophylaxis for HIV negative individuals, proposals for management of safety concerns, and pending plans for scale-up

Forum for Collaborative HIV Research

1608 Rhode Island Avenue, NW

Washington, DC 20036

August 19, 2011

8:30am - 4:00pm

The Forum for Collaborative HIV Research has been tasked by our collaborators in the public health community, including the US Food and Drug Administration, to convene an open public meeting to address safety issues that may surround the introduction of biomedical approaches to prevent HIV infection. Recent data from the iPrEx, Partners PrEP and CDC’s TDF2 studies support a conclusion that pre-exposure prophylaxis (PrEP) with antiretrovirals may be effective at preventing transmission of infection in otherwise healthy, vulnerable individuals upon exposure to HIV. This important finding may lead to scale-up, broad use of PrEP and, potentially, approval of a PrEP indication.

Recently, the drug development paradigm has also shifted with more focus on safeguarding individuals on medications. Premarket studies can miss important safety signals, either because the patient population is different and limited by enrollment criteria, too small to see low incidence events, or exposure is not long enough to identify latent effects. Compensatory behavioral issues may also be a concern upon scale-up. Appropriate communication strategies to reach the intended healthcare provider and the intended vulnerable populations must be identified and formulated. Mechanisms to anticipate and/or control the development of resistant HIV are also important. Finally, public focus as a result of our meeting may identify additional public health issues that should be addressed as well.

The Forum meeting will follow our usual format of panel discussions featuring stakeholders, including academics, trialists, clinicians, community advocates, public health professionals, and others. Each will be asked by a moderator to address a set of pre-prepared questions. Four panels are planned: (1) What are the safety issues of concern with pre-exposure prophylaxis?; (2) what are potential remedies to control safety risks and their pros and cons?; (3) what are the public health implications?; and (4) finally, a panel will summarize and identify next step.

Because of limited space, public participation in the meeting room will be limited to one participant per organization. An overflow room will be available for attendees on an as-needed basis. The meeting will be webcast to enhance national dissemination. Written supplementary questions can be directed to the panels. Webcast attendees can also submit written questions via instant messaging.

Registration: Register online at http://prep-reg.com/ to attend the public meeting or to view the live webcast.

Location: 1608 Rhode Island Avenue NW, Washington, DC 20036
Date and Time: August 19, 2011 8:30 AM-4:00 PM

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Forum Announcements

Studies show new progress in HIV testing in emergency departments

July 29

A CDC sponsored supplement released in the Annals of Emergency Medicine details new HIV testing efforts in Emergency Departments. "Emergency departments play a critical role in helping people learn their HIV status, connecting them to life-prolonging care, and helping them avoid transmitting the virus to others"said Jonathan Mermin, MD, Director of CDC's Division of HIV/AIDS Prevention. Click here to read more

Controlling the HIV Epidemic - The Promise of ARV-Based Prevention: Presentations now available

July 28

Presentations made at the Forum co-sponsored IAS Satellite Symposium "Controlling the HIV Epidemic - The Promise of ARV-Based Prevention" are now available. Click here to read more

Statistical Methods for Causal Inference in Observational and Randomized Studies: Course fees increase on August 1

7/26/11 This course concerns statistical methods for causal inference using observational and experimental longitudinal data. The course will focus on the application of methodological advances in statistical and causal research to improve the design and interpretation of safety analyses. These analyses will become increasingly important in the post-marketing safety environment for new drugs.

Dates: September 26-28, 2011.
Location: UC Washington Center, Washington, DC.

To register, please use the following link: www.hivforum.org/stats2011

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