In 2012, the Food and Drug Administration (FDA) approved the use of the antiretroviral medication Truvada as the first form of PrEP (pre-exposure prophylaxis), a pill to protect against getting HIV. To date, the United States is the only country to give regulatory approval to PrEP for HIV prevention. The Centers for Disease Control and Prevention (CDC) then issued clinical guidelines for prescribing PrEP to adults at risk of HIV. PrEP has been proven to reduce the risk of acquiring HIV equally well in both men and women—with a protection rate of up to 96 percent when taken daily without interruption or missed doses. Yet three years later, PrEP-centric media campaigns and clinical prescriptions continue to primarily target men who have sex with men.
We at the U.S. Women and PrEP Working Group, a national advocacy coalition of more than 100 women’s health advocates, health-care providers, researchers, policymakers, and industry partners, believe that everyone has the right to affordable access to the tools they need to implement their sexual and reproductive choices. Full PrEP availability—for both cis and trans women—is both a reproductive justice and human rights issue. March 10 is National Women and Girls HIV/AIDS Awareness Day. So it’s a good time to ask the question: Why are women being excluded from this potentially life-saving medication?
Of the six oral PrEP studies completed to date, only one took place in the United States. It only enrolled men and a few transgender women who have sex with men. Two international studies that only enrolled women did not show PrEP as successful, but researchers attributed this to the fact that most of the participants did not take the pills daily as instructed. In still other studies involving heterosexual couples, women who did take PrEP consistently achieved a high level of protection—showing that PrEP does work well across the gender spectrum.
Even so, the success of the trial involving American men, combined with the lack of positive data from the trials enrolling women, generated domestic press coverage that generally implied PrEP is “for men,” thus making women invisible as potential PrEP users.
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In the United States, about one in four people living with HIV is a woman. Black women, who make up only 13 percent of the female population, comprise nearly two-thirds (64 percent) of new HIV infections among U.S. women. Yet when sociologist Judith Auerbach conducted focus groups in six U.S. cities among 144 women at high risk of HIV on their thoughts about PrEP, she discovered they were overwhelmingly unaware of the effectiveness of the medication for women.
Fewer than 10 percent of the women had even heard about PrEP; those who had thought it was only a tool for men, not for women. The remaining 90 percent were “upset, frustrated, and even angry that they had not learned of it before.” They saw the failure of health professionals to reach out to them with information about PrEP as a “societal devaluation” of their lives.
In addition to human rights concerns, this kind of low awareness of PrEP’s availability is also highly problematic for practical reasons. Gender-based differences in social and economic power can sometimes make it difficult or impossible for many women to insist on condom use, and consistent condom use is infrequent overall. In a 2010 national probability study, only 22 percent of men and 18 percent of women reported using male condoms during the last ten times they had vaginal intercourse—and cis women are twice as likely to acquire HIV during heterosexual vaginal intercourse without condoms than are their male partners. Finally, women with HIV in the United States are more likely to be living in poverty and have less access to health care than men living with HIV. All of these factors make access to effective HIV prevention, including the option of PrEP, crucial for women.
Advocates are, however, making inroads in ensuring that PrEP becomes part of the narrative for women at risk of HIV. With funding by the CDC Foundation and its partners, the Sustainable Health Center Implementation PrEP Pilot Study (SHIPP) is under way. As the first PrEP study enrolling women in the United States, this demonstration project is designed to show how PrEP provision can be implemented sustainably. SHIPP is enrolling 1,200 volunteers at four federally qualified health centers in Illinois, Pennsylvania, New Jersey, and Texas. These volunteers select PrEP as a part of their sexual health and primary care services. SHIPP’s results—including the rates of PrEP uptake, consistency of use, and protection from HIV—are expected in 2017. To date, about 40 percent of enrolled SHIPP participants are women, a victory for the Working Group and other PrEP supporters across the country.
In the meantime, family planning clinics and private OB-GYNs are well situated to educate women about PrEP, since 99 percent of American women, at some point in their lives, have used contraception. Not surprisingly, cost is a key concern among women considering PrEP use; these facilities can also help patients affordably obtain the medication. At this point, Truvada is the only pill approved as PrEP; Truvada Track, an advocates’ project monitoring PrEP access, reports that it is routinely covered by insurers and Medicaid. Gilead, the pharmaceutical company producing Truvada, also has a patient assistance program that supplies the drug to those without coverage and assists with co-pays to cover the testing and other services associated PrEP access and monitoring.
To choose whether or not to use PrEP, women need information about the medication, clinicians need to be educated about its use for women, and the drug needs to be affordable and accessible. While we are monitoring the implementation of SHIPP, we will continue to pressure policymakers, health-care professionals, and the CDC to reach out to women. In addition, we will continue to mobilize women to demand more.
Everyone deserves the right to HIV prevention tools that we can use without our partner’s participation—for the sake of our safety, health, and well-being. In short, we are tired of asking permission to protect our own lives.