Women and PrEP: A Q&A with Dr. Judy Auerbach
Clinical trials evaluating oral Truvada for PrEP in women have had mixed results, with some (Partners PrEP and TDF2) showing efficacy among women in African countries and others (FEM-PrEP and VOICE) finding none due to lack of adherence, leading to confusion around whether daily oral PrEP is a viable HIV prevention tool for women.
What these PrEP trials have shown is that adherence—taking PrEP daily as directed—is both critical and complicated: PrEP works in people who take the pills as directed, but not everyone in every community and social environment will choose to (or be able to) take a daily pill. As Dr. Judith D. Auerbach of the University of California at San Francisco puts it, “the issue is really that certain women don’t take pills, period.”
To understand how women in the United States view daily oral PrEP and its relevance to their lives, Dr. Auerbach and fellow investigators with nonprofit policy and advocacy group AIDS United are conducting qualitative research—that is, research that gathers data on opinions, attitudes, and knowledge about an intervention such as PrEP.
Dr. Auerbach sat down with BETA at the 21st Conference on Retroviruses and Opportunistic Infections to share updates on this research and offer her take on PrEP for U.S. women.
Given what you know from your own qualitative work and from clinical trials to date, what do you think is most important for people to understand about women and PrEP?
Dr. Auerbach: I think the most important thing for people to know is that PrEP probably works very well for women who actually take it.
iPrEx, the initial study of PrEP efficacy, was done primarily with gay men and a smaller number of transgender women, so PrEP very quickly became understood—at least in the U.S.—as a gay men’s HIV prevention strategy, and a lot of straight women just never thought it was something they should be considering.
Also, the early trials of PrEP that did focus on women—I mean the trials that enrolled women who were perceived to be at high risk for HIV infection in settings in sub-Saharan Africa, not the ones that included women as part of serodiscordant partnerships—did not show efficacy, for reasons to do with adherence. Women were not taking the drugs as prescribed, and consequently the trials did not show PrEP to be an efficacious strategy. But for the women who did take the drug, it was as efficacious for them as it was for any gay man or any individual in a serodiscordant couple.
So I think what we need to do is reverse the lack of consideration of PrEP as something relevant for women, and reverse the sense that PrEP doesn’t work for women. Even at this conference, I’ve heard people say, “We know from the trials that oral PrEP doesn’t work for women,” and I think, “Really?” So I believe that’s our starting point for any discussion about women and PrEP.
You have been working with AIDS United on a focus group project around what U.S. women know and think about PrEP. Where does that research stand?
Dr. Auerbach: We’ve just done a second round with AIDS United; data from the first round were presented at AIDS 2012. This is qualitative research with HIV-negative women whom we defined as “at risk” based on some of their own characteristics, such their use of drugs, engagement in commercial sex, sexually transmitted infection service-seeking, etc., and also their risk environment, such as high HIV prevalence in their communities and networks. The idea was to find out whether women have heard about PrEP and what they know about it—because nobody else is doing this kind on qualitative work independent of a clinical trial or a specific PrEP product. Most of the qualitative work in PrEP trials to date has been done after the trials have concluded.
Women in the first round of our focus groups were predominantly African-American and Latina; in the second round, 91% are African-American. We visited ten U.S. cities total, with two focus groups in each city. Our sample includes over 230 women: 92 in the first group, 144 in the second. The first round was done in Memphis, Oakland, San Diego, and Washington, DC, before oral Truvada was approved for PrEP in the U.S.; the second round was done after the Food and Drug Administration [FDA] approved it for both women and men.
The first thing we learned from the second set of focus groups in six cities—Atlanta, Chicago, Dallas, Newark, New Orleans, and New York—was that almost none of the women had even heard of PrEP. After we talked about PrEP and the fact that the FDA had approved it more than a year earlier, the women’s reaction was, “Why haven’t we been hearing about this? Why are they withholding this from us?”
What we’ve found from the focus groups is that when women learn about PrEP and how it works, they find it a very attractive option for a number of reasons. A number of women in the focus groups said, “This is lifesaving! This is something that could save our lives, so why aren’t we hearing about it? We really need access to PrEP.”
What did women cite as appealing about PrEP?
Dr. Auerbach: The idea that they could just take the pill on their own and help prevent HIV infection, and that it could be lifesaving. There was a little bit of the “stealth” factor, although they didn’t use that word: the idea that you could take it and your partner wouldn’t have to know. They also liked the idea of PrEP because they felt they couldn’t trust their male partners. We asked, “Why might women use PrEP?” and a lot of women answered, “Because you don’t know what your partner is doing.”
When we asked which women might use PrEP, they named every category, from young to old, in prison and out of prison, women who use substances, sex workers, women with multiple partners—but then they’d say something to the effect of, “In the end, pretty much any woman who’s having sex, because you don’t know what your partner’s doing. Even married women.”
The women did talk about the potential drawbacks of and barriers to using PrEP—things like side effects, cost, and mistrust of government-funded research—but overwhelmingly, the response was positive.
Also, a few women said that if someone were seen taking a drug that is recognizable as an “AIDS drug,” that might be a problem. There’s still a lot of confusion about PrEP, PEP (post-exposure prophylaxis), and antiretrovirals for therapy—and the differences are hard to explain to somebody who is looking through your medicine cabinet and asking, “What’s this?”
What does your focus group research tell us about what PrEP means for U.S. women compared with women in clinical trials?
Dr. Auerbach: The big take-home message about talking with U.S. women is that American women may be very different from women in African countries who participated in the trials, in significant ways. In the U.S., lots of women have been taking oral contraceptives for years and are familiar with preventive medicine. We’re also much more of a pill-taking culture. People are so used to taking pills that PrEP isn’t that weird an idea.
That’s not true for everybody, of course, but a big take-home is that we have to understand, going in to these large-scale studies, that not everybody is the same in their experience of preventive medical technologies. For the most part, women in these African studies contracept with injectables, so taking a pill every day for prevention purposes is not something they would necessarily see as “normal.” A lot of people don’t like to take pills.
Also, we asked women in our focus groups for their thoughts about other PrEP formulations, such as injectables, rings, films, and gels. Interestingly, generally speaking, the vaginal ring was the least attractive and the injectable was the most attractive, if it were to have a monthly or less frequent dosing schedule. But there were women who said they would use any of the formulations, so in the end, it was “different strokes for different folks”—which is just like contraception.
U.S. women are used to having a range of options for contraception, so having a range of options for PrEP makes a lot of sense. Different women will use different forms of PrEP at different times in their lives and in the context of different relationships.
Adherence has been called the “Achilles’ heel” of PrEP studies. Did your focus groups address issues around adherence?
Dr. Auerbach: For the second round, we explicitly told the women in the focus groups about the FEM-PrEP and VOICE findings that women weren’t taking the drug. We asked, “Why do you think the women in the studies didn’t take the drug even though they told the investigators they were taking the drug?” We got a range of responses, but mainly they were: Life gets in the way, people don’t like taking pills, and there were incentives and compensation in the trials that were attractive to women even though they did not want to take the pills.
We also asked what level of efficacy would be needed for them to feel comfortable taking PrEP, and their responses ranged from 50% to 90% efficacy. Overwhelmingly, these women really felt that PrEP should be seen as auxiliary to and not as a replacement for condoms, so virtually any level of efficacy was acceptable for adding another layer of protection against HIV. They were also aware of other sexually transmitted infections [STIs] and that PrEP doesn’t protect against them. That said, they also recognized that a lot of women—and men—aren’t going to use condoms if they are taking PrEP.
How do women perceive their own risk for HIV? Risk perception factors in to who is going to ask their doctor about PrEP.
Dr. Auerbach: We kept running into these questions: Who’s at risk, and what perceptions of risk are operating, and in what ways? In our focus groups, we spoke with women in communities with high HIV prevalence, and we recruited women from organizations that serve women in relation to HIV/STI prevention, family planning, housing insecurity, substance use, mental health issues, and social support. We understand from social science research that those are the factors that fuel HIV risk in this country; however, that’s very different from self-perception.
But it was clear that women in the focus groups recognize the “risk environment” as a real factor in their lives. Risk oftentimes resides outside the individual, rather than being just a property of our own behaviors. The groups talked about things like housing insecurity, having sex for money or to survive, and having partners coming out of prison. And they had a sense that we are all at risk in some way.
Women in serodiscordant couples are also a really interesting category of women in PrEP research. We do see women being very aware of their own HIV risk and very adherent to PrEP in trials with serodiscordant couples. Fertility and pregnancy concerns have also become part of the U.S. conversation. PrEP is enabling women in serodiscordant couples (where the man is HIV positive) to have babies without having to go to extraordinary measures to protect themselves from HIV infection.
Also, it’s become really apparent that the field absolutely needs to get information about transgender women and how PrEP is relevant for them. At a recent forum in San Francisco, transwomen from the community made it clear that this is something they should be part of developing and implementing, and that it has great promise for them. One of their main concerns is drug-drug interactions, specifically how hormones might interact with PrEP drugs. This was also found in an informal survey conducted by the U.S. Women and PrEP Working Group, in which 39% of respondents were transwomen. The epidemiology of HIV in transwomen argues for them being a really important population for PrEP.
Based on what you’ve learned from women in the focus groups, what guidance would you offer to providers around talking with their patients about PrEP?
Dr. Auerbach: That’s a challenging question; the answer really depends on who the provider is and what kind of setting and venue they work in.
We asked women in both rounds what they thought would be the best venues or most appropriate sources of information and PrEP services for women. Some thought women would be more inclined to go to a family planning clinic, like Planned Parenthood, where they already have those conversations about reproductive health. But we were surprised to learn that many of the women had very good relationships with their primary care providers and could imagine having a conversation with their provider about PrEP.
But also interestingly, they said, “We can’t trust that providers have all the information. We’re not hearing about PrEP. And if we’re not hearing about it, it means the community-based organizations aren’t hearing about it, because they would be telling us about it if they knew about it.”
The only city where more than one or two women knew about PrEP was Atlanta, with women from SisterLove, because the executive director, Dazon Dixon Diallo, is very active around women and PrEP. Everywhere else, women weren’t hearing about it. So they were extrapolating that the doctors, then, must not know about PrEP, either.
So at the most basic level, providers have to get educated about PrEP and not have a negative view of it. They have to know it has been approved for women and is a reasonable strategy, and that the adherence data from international trials doesn’t mean it doesn’t or won’t work for U.S. women.
When do you expect to present the results from the focus group project?
Dr. Auerbach: We hope to present data from the second round of focus groups at AIDS 2014 in Melbourne, and we are also planning a manuscript for publication.
I presented some preliminary data earlier this week at a meeting among HIV prevention researchers and pharmaceutical industry representatives whose companies are involved in PrEP and microbicides research. I was invited because our project is the first to examine qualitatively what the women to whom they’re going to be marketing their products actually think about PrEP. I think the pharmaceutical reps left with the sense that PrEP may be more attractive to women than they had believed.
Actually, what we anticipated going in to our focus group research was similar to what was discovered in a Gilead study presented at ICAAC [the Interscience Conference on Antimicrobial Agents and Chemotherapy] last September, about who is actually getting prescriptions for PrEP in the United States: They found that nearly half of people prescribed Truvada for PrEP were women. The rest of the field was taken aback, but I think those of us who have been paying attention to women and PrEP weren’t surprised.
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To take a look at Dr. Auerbach’s work and keep tabs on developments around women and PrEP, visit the U.S. Women and PrEP Working Group online and access audio, slides, and other resources.
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Reilly O’Neal is a freelance writer and former editor of BETA.