World Health Organization Latest Statement on the Link Between Hormonal Contraceptives and HIV

via Plus News

Four months after a study suggested women on hormonal contraception may be at an increased HIV risk, the World Health Organization (WHO) has reaffirmed the birth control method's safety, but strongly recommends that women on progesterone-only injections, like Depo-Provera, also use condoms to prevent HIV infection.

In October 2011 the British medical journal, The Lancet, published the findings of a study showing that women who relied on hormonal shots to prevent pregnancy doubled their HIV risk. They also found that women on this type of birth control and living with HIV doubled the chances that they could transmit HIV to their partners.

Although the women in the study did not identify their birth control methods, most were probably using the progesterone-only, depot medroxprogeterone acetate shot. More commonly known by the brand name, Depo-Provera, this drug is the backbone of most African family-planning programmes.

The study prompted WHO meetings in late January and February 2012, during which experts and civil society representatives reviewed research on hormonal contraception and HIV risk. However, because no clinical trial has ever looked specifically at this potential link, including the October 2011 study, evidence remains largely inconclusive.

In the absence of a proven link between hormonal contraception and HIV infection, the WHO issued a statement on 16 February standing by current guidelines that allow women living with or at high risk of HIV to use hormonal contraception. However, the body has recommended that current guidelines be amended to advise women using progesterone-only injections be strongly advised to use condoms concurrently to prevent HIV infection. 

The need for future research into the matter was discussed at side meetings, said Dr Jared Baeten of the US University of Washington, one of the authors of the 2011 study. Although no decision was taken, he added that conducting such a trial would pose serious challenges. About 12 million women in sub-Saharan Africa are estimated to be on injectable contraception.

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

South Africa's Health Services: An Interview with CAPRISA's Dr. Quarraisha Abdool Karim

via AllAfrica.com, interview with Dr.Quarraisha Abdool Karim

Dr. Quarraisha Abdool Karim is an infectious diseases epidemiologist and associate scientific director of the Centre for the Aids Programme of Research in South Africa (Caprisa). AllAfrica's Julie Frederikse spoke to the 51-year-old and asked her about the challenges facing her team as they search for effective ways to prevent HIV and other sexually transmitted infections.

We appreciate that there are many challenges. To simply walk in and say, doctors and nurses, you must now provide this or that - it won't work. We are aware that services are very strained in the public health sector. Morale is low, staff feel overwhelmed, and nurses often don't get sufficient support in the implementation of policy decisions.

So we have been working with the family planning nurses, using a Quality Improvement Strategy model that's been used extensively to improve the quality of health care delivery and access to important health interventions. It's similar to Paolo Freire's work in education, in that we aim to work with health care staff using empowering and enabling approaches.

How would you assess the government's sexual and reproductive health services in South Africa?

This country has one of most enviable lists of contraceptive methods available at no cost, yet the main method used is Depo Provera (which a recent study has shown to double the risk of transmission of HIV to women). There are IUDs and implants, which may be much better, safer options. So why are they not being promoted? Even with the injectables, there is NET-EN (norethisterone enanthate), which has a lower dose of progesterone and has a favourable safety profile for use by young people.

The point is that we have as policy on our essential drug list an extensive group of fertility control methods, so why is this not translated into access at point of delivery? The answer relates to the fact that the normal interaction time between a health professional and a client is very short, sometimes as short as 30 to 40 seconds. This doesn't leave time to consider other contraceptive options. We know you can't change people overnight, especially when their prescribing patterns are limited to just giving an injection, and perhaps asking a question like, 'do you know your HIV status?' But we know that we've got to change health care provision - to include HIV testing, screening for STIs and cervical cancer, just to mention a few. It's got to be part of a comprehensive model for prevention and treatment - but the challenges are in how to integrate this in over-stretched clinics.

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[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.]

Hormonal Contraception and HIV: A New Study Rekindles the Debate

* Original content from our Mapping Pathways blog team

Earlier this month, 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. The New York Times published a story on the study soon after, one that many HIV/AIDS experts are calling “alarmist”. There has been a great deal of press coverage on the study since then. As Dr. Adolfus Muyoti from the George Washington University said in a discussion on the IRMA (International Rectal Microbicide Advocates) listserv, “The news is all over Africa.”

The study, supported by the US National Institutes of Health and the Bill & Melinda Gates Foundation, followed 3,790 heterosexual HIV-1-serodiscordant couples across seven African countries. According to the Lancet, the aim of the study was to determine if hormonal contraceptive use had any effect on the risk of HIV acquisition by women as well as the risk of transmission from HIV-infected women to their male partners. As the below diagram used in The New York Times article illustrates, at first glance the results looks fairly disturbing.

However, as Heather Boonstra, Senior Public Policy Associate at the Guttmacher Institute, points out on the IRMA discussion listserv, “The study is less conclusive than at first appears, and leading experts in the field agree that, by itself, it does not warrant changes to current programs on the ground.”

Isobel Coleman from the Council of Foreign Relations echoes similar sentiments, “The study … adds urgency to a long-simmering debate over whether there is a link between hormonal contraception and HIV … no conclusive work has been done. The Lancet study is also not conclusive due to small sample sizes, and because the study was not specifically designed to examine contraception use.”  She does, however, add that, “The doubts raised are sufficient that a full-blown, conclusive study should be launched as soon as possible.”[1] (To read the complete write-up on the Council of Foreign relations website, click here.)

In Sub-Saharan Africa, where more than 60% of HIV infections occur in women, the ramifications of this link, if confirmed, would be huge. A hormonal shot every three months is the most popular contraceptive method in the region – about 12 million women between 15-49 years of age use these injectable hormones. If hormonal contraception suddenly became less acceptable, Africa would have to deal with the problems of affordability and access that surround other contraceptive methods.

Most healthcare professionals and researchers working in the field agree on the importance waiting for the results to be confirmed and not spreading large-scale panic. Says Mary Lyn Gaffield, an epidemiologist in the World Health Organization’s department of reproductive health and research, “We want to make sure that we warn when there is a real need to warn, but at the same time we don’t want to come up with a hasty judgment that would have far-reaching severe consequences for the sexual and reproductive health of women.”[2]

Perhaps it is Dr. Muyoti sums up the issue best and most succinctly: “This has the makings of a problem that will be highly contentious and will not be resolved in the short term.”

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[1] http://blogs.cfr.org/coleman/2011/10/04/long-lasting-hormonal-contraception-and-the-hiv-epidemic/ 

[2] http://www.nytimes.com/2011/10/04/health/04hiv.html?_r=1&pagewanted=all

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