Will 2015 be the year for PrEP and women?

In the run-up to the busy holiday season here in New York, a number of great pieces focusing on women and PrEP came out, including new data on PrEP knowledge and attitudes, a video depicting one of our favorite stories of early PrEP use in the Bay Area, another great webinar from the US Women and PrEP Working Group, and a piece from a freelance journalist who took on the question of why so many women are still being infected with HIV when there’s a pill to prevent it. Check it all out below!

In late December 2014, data on knowledge, attitudes and likelihood of PrEP use in US women was published in the journal AIDS Patient Care and STDs. The study was conducted by AIDS United and included focus group discussions with 150+ women from across the United States. Key findings include women’s interest in PrEP as an additional prevention tool and identification of potential barriers that to be addressed to provide access for women in the US. Download the article here.

This Pill Prevents HIV, So Why Are So Many Women Still Being Infected?” is a piece that features commentary from a range of advocates and PrEP users, including the story of sex-positive advocate Julie Lynn and her decision to begin taking PrEP. The article reminds readers of the need to ensure the conversation on—and implementation of—PrEP in women includes all women at risk, not just those who are part of serodifferent couples and want to use PrEP for safer conception.

The idea of “PrEP-ception” has been pioneered by women’s health and HIV advocates and has been advanced largely due to early efforts from those at the Bay Area Perinatal AIDS Center (BAPAC) in San Francisco, California. One of the first couples to use PrEP to safely conceive worked with BAPAC. The story of “Poppy” and “Ted” (pseudonyms used to protect their privacy) is one of an HIV-serodifferent couple—Poppy is HIV-negative and Ted is HIV-negative—who wanted to get pregnant without the expense of sperm washing, one of the options used by HIV-negative women looking to get pregnant by their HIV-positive partners. Poppy went on PrEP and had condomless sex with her husband for the first time, which happily led to the birth of her adorable—and HIV-negative—daughter Macey. Check out the Fusion TV segment on their wonderful story.

Circling back to the idea of risk and how to do a better job at ensuring all women at risk know about and have access to PrEP, if desired as an HIV prevention option, the US Women & PrEP Working Group recently hosted a webinar: How Do Women Think about HIV Risk? The conversation around women’s perception of HIV risk and how this perception impacts care providers and PrEP as a prevention option is critical. Sign in here to access slides from the webinar and the recording.

Resources, articles and discussions on PrEP are on the rise, and we’ve highlighted just a few of them here. New usage data show that PrEP use in the US among some populations and communities is going up and one has to imagine that it is partly due to increased, accurate coverage and awareness. But, as described in the article above, the conversation around PrEP and women has not experienced the same amplification effect as that of gay men and PrEP over the last year. More women (and men) can benefit from PrEP than are currently accessing it. We—providers, advocates, public health agencies and anyone who talks to a woman about her health—have to do better.

Will 2015 be the year for PrEP and women? And not just in the US but globally? We sure hope so.

Want more information on the US Women and PrEP working group and its activities? Check it out here. Interested in working with us on this issue in 2015? Drop us a line.

Biomedical HIV Prevention Efficacy Trials, 2014–2016

Prepping Gay Men for PrEP

Adebisi Alimi is an LGBT advocate, former AVAC PxROAR Europe member and a 2014 Aspen New Voices Fellow. This article first appeared in Project Syndicate.

In October, two groups researching the effectiveness of a potential breakthrough drug in the fight against HIV did something unusual. They announced that the therapy they were testing, an antiretroviral drug called Truvada, had proved effective enough to end the randomized phases of the trials, and that they were offering the pill to all of the studies’ participants.

The researchers found that gay men who take Truvada, in addition to using condoms when they have sex, were significantly less likely to contract HIV. This is further evidence of the effectiveness of pre-exposure prophylaxis (PrEP), a technique by which people who are HIV-negative use antiretroviral drugs to protect themselves from infection. In 2011, a trial funded by the Gates Foundation found that straight couples using Truvada reduced the risk of transmitting HIV by 73 percent.

Those fighting to prevent the spread of HIV/AIDS thus have a new tool in their arsenal. The question now is how best to deliver it to those who need it most: gay men in developing countries.

This summer, the World Health Organization took an important step to that end, recommending PrEP for all gay men and men who have sex with men, making it the first major international health organization to do so. The WHO estimates that increased use of PrEP could reduce HIV infections by up to 25 percent over the next decade among men who have sex with men (this category includes anyone with elevated risk, not just those who identify as gay).

But an important obstacle remains: the legal predicament of gay men in much of the developing world. In countries like Nigeria, where anti-homosexuality legislation has recently been approved, those following the WHO’s new PrEP guidelines could find themselves subject to imprisonment.

The climate of officially sanctioned homophobia in Nigeria has already set back the fight against AIDS. In 2006, a study found that 13 percent of men who have sex with men in Nigeria were HIV-positive, compared to 4.5 percent of all Nigerians. By 2012, the HIV rate among men who have sex with men had jumped to 17 percent. Meanwhile, an increasing number of men reported encountering homophobia at healthcare centers, making them less likely to seek help.

The consequences could not be more serious. Two years ago, a young HIV-positive Nigerian man contacted me on Facebook to tell me about his monthly ordeal at the clinic. The nurse at the hospital spent more time lecturing him on the evils of homosexuality than telling him about the drugs he was taking and their possible side effects. The man, a third-year medical student, told me that he had decided to stop going to the clinic. When I asked how he would continue treatment, he said that he had a friend abroad who could get him the drugs. Less than two years later, I saw a Facebook update announcing his death.

My Facebook friend is not the only one who has paid the price for Nigeria’s homophobia. A preliminary report from the Solidarity Alliance Nigeria, a coalition of gay, lesbian, bisexual, and transgender (LGBT) organizations, details a huge decrease in the use of HIV services by men who have sex with men in the six months following the enactment of the anti-gay legislation. The decrease ranges from 40 percent in Lagos – Nigeria’s most cosmopolitan city – to 70 percent in Kano, a predominantly Muslim state.

Nigerians living with HIV must do more than just fight the infection; they also must brave social stigma, weather discrimination by secular and religious institutions, and now, potentially, face threats from the legal system. In this environment, the promise of PrEP begins to dim, as the risks of seeking treatment outweigh the potentially life-saving benefits.

The story is similar in Uganda. Last spring, as legal persecution of gays there mounted, the government raided an HIV clinic and withheld its operating license for providing care and support to HIV-positive men who have sex with men.

As an African activist with more than ten years of experience in the fight against HIV, I hope that the WHO will build on its important first step of advising the use of PrEP. That means initiating a public conversation with countries like Nigeria, Uganda, Gambia, and Russia on the importance of inclusion in the battle against HIV.

The WHO should make it clear that while it may not be advocating for LGBT political rights, it is determined to ensure that all those who can benefit from PrEP are able to access the necessary drugs, without fear of legal consequences. Researchers, drug companies, and human-rights campaigners must take up the fight to ensure that PrEP is made available – without risk – to those who need it most.

UNAIDS Report has Bold Vision, Key Messages—But Needs More Precision on HIV Prevention

UNAIDS recently released Fast Track: Ending the AIDS Epidemic by 2030, its report for World AIDS Day (December 1, 2014). Coming nearly two weeks early, the launch was, itself, fast-tracked—and there’s plenty of “we can’t wait” urgency within the pages of the report, starting with the first page (that does more, typographically, with red ribbons than you might believe is possible). It reads:

“We have bent the trajectory of the AIDS epidemic. Now we have five years to break the epidemic or we risk the epidemic springing back even stronger.”

This is on target and a message to convey urgently and with clarity. UNAIDS has its work cut out as an agency that can provide leadership, mobilize resources and push for the shift to community-based service delivery that emerges as one of the core recommendations in the report.

In broad strokes, it’s the right message, with the right vision, at the right time.

But an effective response depends on strategy, details, milestones, resources and specifics—and these are still lacking. This is to be expected, as the UNAIDS Prevention and Non-Discrimination Targets are still in draft form.

The Fast Track World AIDS Day report is clear on what needs to happen to achieve the “90-90-90” goal that calls for 90 percent of people living with HIV to know their status, 90 percent of those to be on antiretroviral therapy (ART) and 90 percent of those to be virologically suppressed by 2020.

It also suggests the components of prevention programming that should also come on line—listing, in various places, male and female condoms, voluntary medical male circumcision, oral pre-exposure prophylaxis (PrEP) for sex workers, men who have sex with men, serodiscordant couples and adolescents, as well as cash transfers for young girls, harm reduction, structural interventions, mass media and behavior change. These prevention elements appear in different subsets throughout the document, leaving some confusion about what, exactly, is essential.

Everything that the UNAIDS report lists is important. But the details of what goes where—which packages, in which places—and what specific terms mean are missing. Cash transfers, for example, can be delivered in a range of ways, with different objectives and different outcomes.

There are also some elements that receive considerably less emphasis. Research and development of more potent ARVs for treatment and prevention, new prevention options for women and other key populations, vaccine and cure strategies, are fundamental to long-term success in “breaking the epidemic”. Within the five-year timeframe set by UNAIDS, there are short-term milestones to set and achieve in each of these areas, even though the ultimate goals may not be reached for many years.

The good news is that this is a solvable problem. We as advocates and activists must use our impatience and collective wisdom to fast-track a process to ensure that clear targets, resources and messages are developed with the same strategy, rigor and urgency as 90-90-90.

AVAC is working with many of our partners to inform this process. This new report adds urgency to this task and clarity to the questions we need to address. As the report stresses, we must all “hold one another accountable for results and make sure no one is left behind.”

In the coming days, AVAC will release “Prevention on the Line”—a briefing paper with core recommendations for effective target-setting across the research-to-rollout continuum. This will summarize core messages and analysis that will be expanded in AVAC Report 2014/15. To receive the Report and other updates in your inbox, please join our Advocates’ Network. Stay tuned—and stay in touch.

Click here to download the new UNAIDS report.

PrEP by the Numbers: Efficacy, regulatory approval and more

PrEP works if you take it. The figures on this graphic show the relationship between PrEP efficacy and adherence and the status of regulatory action on PrEP worldwide. It also shows other potential new formulations of ARV-based prevention being evaluated as additional options in the future.

Evidence for PrEP builds

Over the last few weeks the PrEP for HIV prevention field has been boosted by positive news from two ongoing research studies in Europe: PROUD and IPERGAY. In each study, use of TDF/FTC (brand name Truvada) for PrEP reduced risk of HIV acquisition. The exact numbers behind the recent announcements are not yet available (in each case the data was reviewed by the trial’s independent data safety and monitoring board and will not be available more widely until published or presented, which is expected in early 2015 for both), but daily and “on-demand” (taken before and after sex) TDF/FTC as PrEP were effective at reducing risk in gay men and other men who have sex with men.

A lot has been written about these promising advances and what the announcements mean for regulatory approvals and PrEP access in Europe, the effectiveness of “on-demand” versus daily PrEP and the mounting evidence of PrEP’s utility as an important HIV prevention option. 

Aidsmap.com editor and long-time writer and activist Gus Cairns penned a piece for Huffington Post, D-day for the Pill for HIV, noting how these two studies and their show of PrEP effectiveness together mark a turning point in HIV prevention. His cogent analysis is a must-read. 

The US Centers for Disease Control and Prevention notes that the trial announcements are “encouraging” and that they look forward to seeing trial data for more information, particularly from IPERGAY, on dosing and timing required for protection. 

From the HIV R4P conference “live blog”, Emily Bass writes on PrEP for a New Era, describing the new data and the energy around PrEP exhibited at the conference.

PROUD study team statement is available here and the ANRS’ statement on IPERGAY is here.

For the latest on PrEP, visit avac.org/prep.

Why we young women had to resort to putting up the Visible Panty Line

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

Wednesday was the day we were finally going to be seen and heard: the day that young women from Burundi, South Africa Uganda and Kenya were going to make it all about us. While everyone was in plenary session, we young women plotted to get the most attention when researchers, policy makers and the conference elite walked out of the plenary. Well, we did succeed in catching their collective eye with our visible panty line (VPL)—a clothes line with colourful, sexy lingerie clipped to it. This attracted scores of conference-goers to our corner. But while everyone was curious, not everyone wanted to participate in the activity—which involved writing messages and clipping them to the line. Instead, I watched as the usual suspects wrote messages about issues affecting young women and a few wrote about strategy ideas to improve the young women’s agenda. I was secretly waiting for a researcher to prove me wrong.  None did.

This was disappointing because we young women have a lot to say to researchers about the prevention options we want – if only they would listen. For instance, we know that PrEP works. We know young women between the ages 19-24 are most affected in many parts of the world. We also know this group hasn’t been a priority for demonstration projects of PrEP (pre-exposure prophylaxis).

I attended two oral poster presentations on PrEP and microbicides adherence in women. Speaker after speaker explained that they had gathered evidence about how women lie in about product use (aka adherence) trials. I wanted to say to them: “We do not lie as a choice but as a negotiation. Women lie to their partners, to their family, to their community and in trials because we prioritize other people and not themselves. Some of reasons given to explain that “the lies” were – “I did not use the gel because my partner does not like the slipperiness”, “My partner felt it and I had to remove it.” Women who didn’t use a PrEP or microbicide containing an ARV had their samples measured for detectable drug in the blood. They were told their pharmacokinetic levels that indicated no product use. “I beg you to forgive my PK levels,” was one of the responses I observed. Why do we do it?

After all these lies, I rush back to the Advocates Corner and our Visible Panty Line.

Phew, these young women, like our mothers, have submissively found their space on the floor. And then the old women came and the heterosexual man came: again they wanted to help young women. This is what they should do or shouldn’t do. But why don’t they want to listen to the women themselves?

I am livid: they are doing it again! They are gagging young women.

Arm advocates with the appropriate facts so that they can drive change in their own countries

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

Maureen Milanga, a staffer at Health GAP in Kenya and an alumna of the AVAC Advocacy Fellows program, presented a poster demonstrating how advocates from Kenya, Zimbabwe and Nigeria were able to influence their countries by strategically raising their voices to increase demand for key interventions. Their work has helped secure a number of significant changes—including global WHO guidelines that recommend early ART initiation for sero-discordant couples regardless of CD4 counts. Demand is also driving expanding attention to the need to deliver post exposure prophylaxis (PEP – ARVs given after a person suspects they have been exposed to HIV) for key populations like sex workers in Zimbabwe and South Africa. There has also been increased effective engagement of communities in trials.

However, a lot still needs to be done to scale up pre-exposure prophylaxis, or PrEP (programs that provide ARVs to HIV-negative people to reduce their risk of HIV infection). This includes additional research, demonstration projects and large scale roll out programs.

It is important to note that advocacy requires appropriate strategy for each country in order to create meaningful change. They need to be given basic facts about the research and the prevention/treatment options for them to influence policy makers. Advocates can then frame arguments that help the policy makers see themselves as beneficiaries of the action—whether by saving costs, lives or earning the respect and alliance of the key constituencies driving change.

PrEP for a New Era

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

It was an exciting morning for pre-exposure prophylaxis (PrEP) using daily oral TDF/FTC (brand-name Truvada). In the morning plenary session, Chris Beyrer, of Johns Hopkins University and president of the International AIDS Society, spoke about HIV prevention in sex workers, gay men and other men who have sex with men. Beyrer pointed out that there is only one country implementing PrEP—the United States—at a national level.

“I can’t wait until the PrEP era begins,” Beyrer said. “Hopefully it is going to be soon.” Beyrer is a staunch human rights advocate—founder and director of the Center for Health and Human Rights at Johns Hopkins—and it is good to hear support for PrEP in the context of a rights-based response. As he noted, there are many concerns in civil society about biomedical interventions like PrEP and ART for treatment and prevention, since the medical establishment is, often, linked with the state—eg governments that may be actively criminalizing and persecuting the very populations who are being targeted with new biomedical strategies. Beyrer’s embrace of both rights and biomedical interventions is exactly what’s needed—and it will be exciting when the PrEP era, as he defines it, begins.

Speaking of the PrEP era, it took a leap forward while the plenaries were taking place, as the French research agency ANRS released a press release announcing that its IPERGAY trial, which had been designed to evaluate intermittent PrEP use, had found evidence of efficacy and was going to end its randomized, placebo-controlled design.

Briefly, this trial was launched after the iPrEx trial of daily oral PrEP showed efficacy in gay men, other men who have sex with men and transgender women. It sought to test intermittent use and had a placebo arm—a design decision that raised ethics questions from the outset, given the evidence of efficacy from iPrEx. The investigators had explained that since PrEP was not available or evaluated in France, the design was warranted. Plenary speaker Brigid Haire, who gave a compelling, nuanced talk on trial ethics and biomedical prevention, mentioned these questions specific to IPERGAY—perhaps at the precise moment that the press release was being released announcing the changes in the trial. (Kudoes to Haire and indeed anyone who isn’t checking email compulsively during conferences…)

In a delicious turn of phrase, Haire referred to the “tantalizing whiff of data” from the UK PROUD study of PrEP in gay men and other MSM. This trial found compelling evidence of efficacy earlier this month—a finding that triggered a review of the IPERGAY protocol. It’s exciting when a field evolves in real time—let’s hope it keeps happening, as fast as Beyrer suggests it should.

Young women influencing the agenda

This was originally published on the What’sUpHIV blog that provided live coverage during HIV R4P 2014.

In a session on Reproductive hormones and HIV risks, the data showed the need for the ECHO trial, which is a proposed trial that would evaluate three different contraceptive methods (DEPO-provera, the Jadelle implant and the copper IUD) in relation to HIV acquisition. There’s been a lot of debate and discussion about ECHO recently.

The presentation by Christine Wall on hormonal contraception use and the risk of female to male HIV transmission in a Zambian Cohort showed no HIV risk for men in discordant relationships. Elizabeth Byrne’s presentation showed there is some risk of HIV acquisition among injectable progestogen contraceptive (IPC) users in South Africa compared to women who were not using hormonal methods. Byrne also looked at why this might be. She looked at both the natural hormone, progestogen and progestin (the synthetic form of the hormone). Women who are not using hormonal contraceptive and are ‘cycling naturally’—getting their periods—have regular changes in levels of progestogen. IPC users have high levels of progestin due to the contraceptive. In both of these groups of women, elevated hormone was linked to elevated levels of HIV target cells in the cervix.

At the end of this session, Helen Rees, one of the principal investigators of the proposed ECHO trial spoke to the continued need for this trial. She remarked that the data—including presentations from this session—were confusing and/or contradictory, thus the need to get adequate and accurate answers from ECHO as to to whether hormonal contraception increases the risk of HIV. She spoke to the real possibility of the ECHO trial happening noting that it “appeared” it would move forward. This wasn’t a firm confirmation—an important clarification since the session chair suggested that it was certain.

In a lunch-time session at the Advocates Corner, young women advocates and researchers had a dialogue on young women’s access to HIV prevention: past, present and future. Young women from Uganda, Kenya, Burundi, South Africa, Zimbabwe and other regions, raised issues of lack of sexual and reproductive health (SRHR) access, including family planning and information. One participant noted that the young women want to use pre-exposure prophylaxis (PrEP) but it is not available. American advocate Anna Forbes stressed that the initial demonstration projects have not targeted young women even though they are more at risk for HIV infection. Plans are underway for demonstration studies for young women in South Africa and Kenya that will answer if PrEP is feasible among young women. There is therefore a need for young women to start influencing the agenda to address their specific needs.

During a presentation today on PrEP and Microbicides adherence in women, extensive evidence was presented on why some women were not using the products. There was evidence presented on why some women did not use the product. Reasons ranged from having non -supportive partners, fear of possible side effects to peer pressure. The researchers described the impact of discussing “PK” data with participants in VOICE. PK stands for pharmacokinetics, and in this case it refers to the presence of detectable drug in the women’s blood (both the gel and the oral pill in VOICE had tenofovir-based drugs). Adherence to the products was very low in all the VOICE arms—and there was no evidence of protection in any arms.

In a follow up protocol known as VOICE-D, study sites talked to women about their product use, and then also shared the PK data for individual women. Women who said they had adhered very well sometimes changed what they disclosed when their PK data was shared—showing that they had not It was exciting to hear that giving women P.K results initiated discussion on product use. One of the interesting points in the session seemed to be that there is a difference in how long it takes for PrEP to begin to provide protection in women versus men—we’d like to follow up and learn more. Very little was presented on why some women did use the microbicide products in the VOICE trial.