The Search Continues for Female-Controlled HIV Prevention Methods: Ibis Reproductive Health/Cervical Barrier Advancement Society

By Julia Matthews

The number of women infected with HIV rises each year across the globe. In the United States today, women account for more than one quarter of all HIV/AIDS diagnoses and AIDS is the leading cause of death among black women ages 25--34 years.¹ In sub-Saharan Africa, close to two-thirds of people living with HIV in 2006 were women.² In fact, for every 10 adult men infected with HIV in this region, there are approximately 14 adult women who are HIV-positive.³

Women and girls are at high risk for HIV infection due to a number of factors, including biologic vulnerability, economic dependence, and a lack of power in their relationships. Because men do not always agree to use condoms, there is an urgent need for HIV prevention methods that women can control. (See the May/June issue of the WHA for an overview of microbicides' role in HIV/AIDS prevention.) One idea currently being explored is using the diaphragm to prevent disease transmission. Because the cervix is both more vulnerable to infection than are other parts of the vaginal tract, and home to many cells that can be infected by HIV, researchers recently conducted a study to determine whether covering the cervix with a diaphragm during sex reduces a woman’s HIV risk.

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 participated in the study; these women received voluntary counseling and testing, safer-sex counseling, free male condoms, and diagnosis and treatment of sexually transmitted infections. Half of these participants (the intervention group) were randomly selected to receive, in addition, a latex diaphragm and Replens gel, which is a non-contraceptive lubricant.

Unfortunately, the MIRA results 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 to use as protection.⁴ Therefore, the results do not support the addition of the diaphragm to current HIV prevention strategies for women. 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 and the trial’s important qualitative findings also will inform future research on female-controlled prevention methods.

Despite these findings, the MIRA team concluded that studies should continue to examine the potential of cervical barriers for HIV prevention. Future research may address validating participants’ self-reported behaviors or assessing their adherence to study products (e.g., use of the diaphragm). Meanwhile, new kinds of cervical barriers are being developed such as the SILCS diaphragm, a one-size-fits-most diaphragm, and the BufferGel Duet™, a combination microbicide and diaphragm-like device. The diaphragm may also be an ideal applicator for candidate microbicides (topical products that can reduce the risk of HIV and other sexually transmitted infections when inserted before sex), because it has a long history of safe use, has been approved by regulatory bodies around the world, and is reusable.

Currently, the female condom is the only existing female-initiated HIV prevention method, and merits greater investment and efforts to promote its use globally. Equally important is continued research on female-controlled prevention methods such as microbicides and an AIDS vaccine. Greater access to existing methods and the identification of new female-controlled HIV prevention methods are key steps to saving the lives of women and girls worldwide.

For more information about the MIRA trial results, cervical barrier research, or female-controlled HIV prevention methods, visit the Cervical Barrier Advancement Society or the Women’s Global Health Imperative.

REFERENCES

1. Centers for Disease Control and Prevention (CDC), “CDC HIV/AIDS Fact Sheet: HIV/AIDS Among Women,” Atlanta: CDC, June 2007, p. 1.

2. Joint United Nations Programme on HIV/AIDS and the World Health Organization (UNAIDS), AIDS Epidemic Update, Geneva: UNAIDS, December 2006, p 4.

3. Joint United Nations Programme on HIV/AIDS and the World Health Organization (UNAIDS), AIDS Epidemic Update, Geneva: UNAIDS, December 2006, p. 5.

4. Padian NS, van der Straten, Ramjee G, et al. “Diaphragm and lubricant gel for prevention of HIV acquisition in Southern African women: a randomized controlled trial.” Lancet 2007; 370(9583): 251-61.

From 2005 to 2007, Julia Matthews served as the Executive Director of the Cervical Barrier Advancement Society as part of her role as a project manager at Ibis Reproductive Health. She recently left this position to pursue a nurse practitioner degree in adult and women’s health at the MGH Institute of Health Professions in Boston, MA.