Due to biological, socio-cultural and economic factors, women and girls around the world are more vulnerable to HIV infection. In the U.S., AIDS is the leading cause of death among black women ages 25-34 years and is the third most common cause of death among all women in the U.S. Two-thirds of HIV infections are concentrated in sub-Saharan Africa, where women are disproportionately affected. In South Africa, young women ages 15 to 24 are four times more likely to be HIV-infected than their male counterparts. In Zimbabwe, where one in five adults is infected with the virus, women have an average life expectancy of 34 years, one of the lowest in the world.
Given these startling statistics, it is clear that female-controlled methods for HIV prevention are urgently needed and any viable option to protect the health of women and girls must be pursued. One alternative that has been investigated is the diaphragm, which women could potentially use without their partners' knowledge. Because the cervix is more vulnerable than other parts of the vaginal tract and is home to many cells that can be infected by HIV (PDF), researchers conducted a study to determine whether covering the cervix with a diaphragm during sex would reduce women's risk of HIV infection.
The Methods for Improving Reproductive Health in Africa (MIRA) trial, led by researchers at the University of California, San Francisco, was a randomized, controlled trial that measured the effectiveness of the diaphragm and lubricant gel in preventing HIV infection among women. More than 5,000 sexually active women from South Africa and Zimbabwe received voluntary counseling and testing, safer-sex counseling, free male condoms, and diagnosis and treatment of sexually transmitted infections. Half of these participants (intervention group) were randomly selected to receive, in addition, a latex diaphragm and ReplensTM gel, a non-contraceptive lubricant.
What did the MIRA study team find? Unfortunately, the MIRA results, published earlier this month in the medical journal, The Lancet, showed that there was no statistical difference in the rate of new HIV infections between women in the intervention group and those who only received male condoms. Therefore, the results do not support the addition of the diaphragm to current HIV prevention strategies. Although these results are disappointing, it is important that this research was done. The MIRA trial made a significant contribution to the HIV prevention field by providing valuable data and experience on the conduct of these trials, offering health services to trial participants and their partners, and educating women and their communities about HIV prevention options. Additionally, the trial's qualitative findings — for example, on women's and their partner's experiences using study products — will inform future research on female-controlled prevention methods.
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What do the results of the MIRA trial mean for cervical barrier research? The MIRA team concluded that the potential of cervical barriers to prevent HIV must continue to be studied. Future research may have to tackle how to validate self-reported behavior by participants and adherence to study products and find ways to measure modest levels of protection. In the meantime, new kinds of cervical barriers are being developed such as the SILCS diaphragm (discussed recently on this site) and the BufferGel DuetTM, a combination microbicide and diaphragm-like device. In the future, the diaphragm may also be an ideal applicator for microbicides, as it is an available and reusable device.
What's next? At this time, it is critical that we make greater investments in the female condom — the only existing female-initiated HIV prevention method. Improving uptake of the female condom is equally as important as continued research on female-controlled methods, like the search for an effective microbicide and AIDS vaccine. No one method will be right for every woman or girl but every new prevention method we put into women's hands is an advancement for reproductive health and rights. Women and girls still need to overcome the unequal power differences in their relationships; efforts to support their economic empowerment, expand their education options and to increase their social status are essential. Until women and girls can always decide when they have sex, with whom, and which contraceptive or HIV prevention method they use, they need to have as many tools at their disposal to protect their health. Greater access to existing methods and identifying new female-controlled HIV prevention methods will be key steps to stemming the tide of the HIV pandemic.