The Female Condom in the Age of Antiretroviral-Based HIV Prevention

With the recent demonstration that antiretroviral (ARV) drugs are efficacious in reducing the risk of transmission from HIV-positive men and women to their uninfected partners (treatment as prevention) ¹ and acquisition of HIV by uninfected exposed men who have sex with men and possibly also women (preexposure prophylaxis or PrEP), ^{2 –4} prevention experts may reasonably question whether more resources should be devoted to promoting physical barrier methods, such as the female condom (FC), for protection against HIV. Even as research, programming, and advocacy around the FC have grown—and despite strong evidence of efficacy equivalent to that of the male condom (MC) ^5–6 —the FC continues to be used by a relatively small percentage of U.S. women ⁷ and an unknown but likely small percentage of women globally, fueling skepticism about its value.

Since the first female condom was approved by the U.S. Food and Drug Administration (FDA) in 1993, a committed cadre of researchers, policymakers, and advocates has promoted its use. Because it has lower use-effectiveness than hormone-based contraceptives and because, like the MC, it is used coitally and requires some partner negotiation, the FC has not been wholeheartedly embraced in either the family planning or HIV/sexually transmitted infection (STI) prevention worlds. Nevertheless, within the past 6 years, there have been some important advances. Health departments in New York, Washington, DC, Houston, and San Francisco and other governmental and nongovernmental organizations have scaled up FC advocacy, outreach, distribution, and programming. The United States Agency for International Development (USAID) has dramatically increased international shipments of FC, ⁸ and the United Nations Population Fund (UNFPA) has promoted innovative local programming. ⁹ Also, differently designed FC are already available or are making their way through clinical testing and regulatory processes. ^10,11 All these developments suggest that interest in and demand for woman-initiated physical barrier methods are growing; yet resource allocation to FC programming remains low overall and may drop further as a consequence of enthusiasm over the promise of ARV-based prevention.

The key arguments between FC advocates and discounters are two: (1) Is sustained uptake of the FC low because many women—and men—for a variety of reasons do not like the FC or because making the FC available without ensuring consistent supplies and educational support is insufficient to boost demand? (2) What constitutes an important number of users to justify spending valuable public and quasi-public prevention dollars for FC purchase, distribution, and programming? The answer to the first question depends more on evidence and to the second more on values.

In their study, “Initial and Sustained Female Condom Use Among Low-Income Urban U.S. Women,” Weeks et al. ¹² contribute to the evidence. They set out to determine if removing two critical barriers to adoption of the FC, availability and knowledge about how to use it, could lead to an increase in uptake and continued use among U.S. women at high risk of infection. In their study, women were recruited and assessed at baseline, given instructions on how to use the FC, supplied with three FC, and informed where they could obtain additional supplies if needed. Participants were assessed 1 month and 10 months after the baseline interview and FC demonstration. At baseline, 28.6% of women reported having used the FC. At 1 month, 72.7% of never users had tried the FC. At 10 months, 40.8% of those who had ever used the FC (37% adjusted for attrition) were still using it. Overall, 24% of all women were sustained users at 10 months, meaning they had used the FC at baseline or 1 month and at 10 months.

The Weeks et al. study ¹² might be criticized on some counts. For example, the intervention was not randomized but given to all women, and the investigators did not pre-specify what level of uptake would be meaningful. As is often the case in prospective studies of high-risk populations, there was considerable loss to follow-up; however, the authors carefully accounted for attrition using statistical methods. The study makes an important contribution by demonstrating that a modest intervention can result in adoption of the FC by some high-risk women. Notably, the findings are in accord with those of other recent U.S. studies. ^13,14

Some might see these findings—that at most, 24% of those initially exposed to the brief educational intervention were still using it 10 months later—as confirmation that women do not like the FC. Before drawing this conclusion it is important to consider the comparison. For example, in the CAPRISA 004 trial of tenofovir vaginal microbicide gel, ¹⁵ about 40% of women had <50% adherence to the product, which they were instructed to use before and after coitus, not unlike instructions for MC and FC use. This level of adherence was achieved in a clinical trial, in which women received extensive adherence support. We also have very little evidence that women, other than those who are in serodiscordant partnerships, will want to adhere to daily oral PrEP. The Fem-PrEP trial was halted for futility, and women's adherence despite extensive counseling appeared to be low. ¹⁶ Should we thus conclude that women do not like microbicide gels or oral PrEP? No one has drawn that conclusion. Instead, researchers are looking for ways to enhance adherence and to target these prevention methods to people who are most likely to adopt them. ¹⁷

In a time when HIV prevention experts increasingly understand that there is no magic bullet and that combination prevention will win the day, and when family planning experts likewise understand that options counseling increases the probability that women will be covered by at least one contraceptive, both groups need to “embrace the niche” ¹⁸ represented by the FC. Doing that would mean two important changes in practice. First, all health departments should follow the lead of New York, Washington, DC, Houston, and San Francisco and widely distribute the FC free or at low cost along with educational and promotional materials, a program that in the District of Columbia was shown recently to be cost-effective. ¹⁹ Second, it would mean that all gynecologists and other family planning providers promote the FC as a viable and valuable option for women who do not want to use hormonal methods or need protection against STIs, including HIV. Finally, on a wider front, our government needs to continue—indeed, increase—its commitment to global FC distribution and programming, even as efforts to find a safe and effective vaginal microbicide move forward. As women's health advocates, researchers, and providers, we need not dismiss the excitement over ARV-based HIV prevention or the benefits of long-acting contraceptives to also enthusiastically support the FC in family planning and HIV/STI programs.