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Status report on the female condom: What will increase use in the U.S.?
Female Health Co. to seek federal approval for updated condom
When you counsel on protection against HIV and other sexually transmitted diseases (STDs), where does the female condom fit into your message? While the female condom represents a woman-controlled form of protection against HIV and other STDs, its use has lagged in the United States since its introduction in 1993.
This fact may change if the Female Health Co. (FHC) is successful in gaining Food and Drug Administration (FDA) approval of the second generation of its original female condom, known as the Reality or FC1 condom. Documentation for the FC2 is in final stages of preparation. At press time, the application was scheduled to be filed with the FDA by the end of December 2007.
The FC2 is available to several countries outside the United States. To date, approximately 7 million units have been distributed, according to Jack Weissman, company vice president. The company has partnered with the United Nations Population Fund to scale up education programs and distribution of the female condom in more than 20 countries, including nationwide distribution programs in Zambia, Zimbabwe, and Malawi. FHC moved forward in 2005 with the second-generation FC2 Female Condom; large-scale distribution of the FC2 began in 2007.
The FC2, made of nitrile, looks and performs in a statistically similar manner to the original FC Female Condom,1 yet it is less expensive to manufacture. Due to the manufacturing process involved in making the FC1, its price (about 72 cents per unit) was not impacted by bulk purchasing. Since the FC2 carries a less expensive manufacturing cost, it can be made available for as little as 22 cents per unit.2
As a contraceptive, female condoms are slightly less effective than male condoms, but are slightly more effective than other barrier methods.3 Six-month failure rates for the female condom range from 0.8% to 9.5%.4,5 It is estimated 21% of women will experience an unintended pregnancy during the first year of typical use; with perfect use, that rate falls to 5%.6 On the other hand, results of use-effectiveness studies indicate that the female condom is at least as effective as the male condom in preventing STDs.7-9
Research indicates that women in public STD clinics will try, and some will continue, to use female condoms when they are promoted positively and when women are trained to use them correctly and to promote them to their partners.10 Current U.S. use of the female condom is low. According to results of a New York state study, while 69% of females said they had heard about the method, less than three in 100 women (2.6%) reported actually having used one.11 New York state is committed to increasing usage numbers; its Female Condom Promotion Program plans to work with about 60 agencies that provide risk-reduction counseling to heterosexual women.12 Agency directors and counselors will receive a multi-level intervention to promote FC use.
PATH eyes female condom
Researchers at the Program for Appropriate Technology in Health (PATH) are developing another form of the female condom, the Woman's Condom. Working with couples in Khon Kaen, Thailand; Cuernavaca, Mexico; Durban, South Africa; and Seattle, researchers have looked at more than 50 design generations in more than 300 unique prototypes. The current prototype replaces the inner ring of the current female condom with four small dots of soft, absorbent foam. The dots adhere to the interior of the vagina, hold the condom in place during use, and release from the vaginal walls on removal. To make for easy insertion, a rounded cap has been added to the end of the condom; it gathers the condom pouch together until after insertion. Once the condom is inserted, the tip quickly dissolves.13
After extensive evaluation and testing, the Woman's Condom is ready for a combined Phase 2/3 clinical trial, the last step before FDA approval. Its first step is to obtain a commercially produced product. According to Joanie Robertson, PATH's team leader for the Woman's Condom, the agency is identifying a manufacturer to produce the condom. Family Health International has completed a study of the PATH Woman's Condom; it has not yet been published, states Robertson. Results of a small short-term acceptability study indicate the PATH condom is easy to use, stable during use, comfortable, and satisfactory during sex among users.14
Despite strides in microbicide development, there still is no commercially available product, outside of the female condom, that women can use to help protect themselves against HIV/AIDS. Protection is desperately needed: Women now account for more than one-quarter of all new HIV/AIDS diagnoses in the United States.15 Women of color are especially affected by HIV infection and AIDS; in 2004, HIV infection was the leading cause of death for black women (including African-American women) ages 25-34 and the fourth leading cause of death for Hispanic women ages 35-44.15
Women who are in marriages or are cohabitating (in a union) with a man are particularly vulnerable to HIV and STDs, says Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. These relationships have been called "trust" relationships; for women in these types of relationships, use of a male condom is fraught with problems, unless that male condom is being used as a contraceptive as well, Hatcher notes.
"Use of male condoms in marriages, in unions, and with long-time boyfriends imply a lack of trust, hence the importance of an effective, inexpensive female condom, microbicides, and vaccines against HPV, HIV, and other sexually transmitted infections," says Hatcher.