Despite the success of family planning programs worldwide, more than 120 million couples who do not want to get pregnant lack access to contraceptives to delay or space births. Consequently, women in many regions continue to experience high rates of unintended or unwanted pregnancies, with high rates of pregnancy-related morbidity and mortality.
Women also represent a disproportionate percentage of people living with AIDS. Sexually transmitted infections (STIs) represent the second most prevalent cause of poor health in women, especially young women. Almost two decades ago, women identified their need for more options to protect themselves against pregnancy and STIs. PATH, an international nonprofit organization based in Seattle, has developed two new technologies to improve women's options for protection from pregnancy and STIs.
The SILCS diaphragm (PDF) is a single-size, reusable cervical barrier that provides a new option for dual protection. Standard diaphragms are difficult to supply in low-resource settings because they come in many sizes and require a trained provider to fit them. The SILCS diaphragm's single-size design overcomes these obstacles and offers discreet protection for women whose partners cannot or do not want to use a male or female condom.
Women evaluated hundreds of prototypes during the design process to enable PATH researchers to refine the features of the SILCS device. The result is a design that is easy to use, comfortable, and acceptable for both women and their partners. The benefit of this user-centered design process is that acceptability is built in at every step. Couples participating in studies in South Africa, Thailand, the Dominican Republic, and the United States reported that the SILCS diaphragm was easy to use and acceptable, even when women had no previous diaphragm experience.
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Clinical studies have also shown that the SILCS device fits most women and performs as well as a standard diaphragm. The large clinical study to evaluate contraceptive effectiveness of the device will be launched later this year in the United States. The SILCS diaphragm could be approved for marketing as a contraceptive by the United States Food and Drug Administration (USFDA) by 2010.
Now PATH and others are interested in evaluating the SILCS diaphragm as a microbicide delivery system. Using a microbicide with the SILCS device would enhance the partial effectiveness of both methods for increased protection. Plus, using the SILCS diaphragm to deliver a microbicide could reduce messiness of a gel alone and allow women to insert gel in advance of sexual intercourse—a real advantage for those who want to be spontaneous.
Female condoms are another important product that offers dual protection. Recent international declarations have identified access to female condoms as an integral component to ensuring universal access to HIV prevention, treatment, and care. However, in most countries male condoms still are the only method available for HIV/AIDS prevention. Wider access to female condoms, as well as male condoms, is needed to deliver on our commitment to protecting women's health.
The Female Health Company currently produces the only globally available female condom providing dual protection against unwanted pregnancy and STIs including HIV. The FC Female Condom® was approved by the USFDA and has been introduced in nearly 100 countries. In 2005, Female Health Company launched its second-generation product, the FC2, which offers the same product characteristics but with a potentially lower cost.
Based on a decade of women's experience with the first female condom (FC Female Condom®), and working closely with women in Mexico, South Africa, Thailand, and the United States, PATH developed an improved female condom. The PATH Woman's Condom is easy to handle and insert, stays stable in the vagina during use, and is comfortable for both partners—all improvements over the existing product that users asked for.
The design was completed in 2003, and the Woman's Condom was tested by couples in three countries in 2004 for acceptability. Over 90 percent of these couples, including nearly half who had no previous female condom experience, were satisfied with its performance for ease of use, stability, comfort, and sensation. Additional independent trials of the PATH Woman's Condom in 2005 confirmed good acceptability and easy use and showed women's preference for the PATH condom over the FC Female Condom® by about 2 to 1. PATH is planning for the clinical trials required for market approval. The product could be available in one or more countries within the next three to four years.
No single product will meet the needs of all couples for protection across their lifetime. Couples need access to a choice of barrier protection products to find the ones that will be acceptable and appropriate in different relationships and at different stages of life. However, products that are easy to use, broadly acceptable, and introduced as part of a comprehensive dual-protection program will lead to higher levels of protected sex. The women-centered design process used for both the SILCS diaphragm and the Woman's Condom helped PATH develop products that are easy to use, widely acceptable, and have broad cultural relevance. The next steps are to identify the commitment to bring these products to market and invest in comprehensive programming to ensure product availability.
These products were developed with funding from the United States Agency for International Development (USAID) through the CONRAD program, and also with support from the Bill & Melinda Gates Foundation, The Lemelson Foundation, and other donors.