In the early 20th century, distribution of and education about contraceptives were illegal in the United States, leading to the widespread use of ineffective contraceptive methods. This continued until Margaret Sanger visited a Dutch birth control clinic where she learned about diaphragms and thus began a revolution in the United States. The diaphragm was the first safe and effective woman-initiated contraception in much of the world and was widely used in the United States and other countries until the introduction of the birth control pill. While use of the device has decreased over the past 50 years, a comeback may be in the wings.
The SILCS Diaphragm, set to officially launch in Europe this June, is the first new cervical barrier method that will enter the market in more than a decade.
PATH, in collaboration with CONRAD and funded by USAID, designed the one-size-fits-most SILCS Diaphragm to increase access to nonhormonal barrier contraception for women in low-resource settings, as well as developed countries. PATH led a user-centered design process involving input from women, their partners, and providers. The design was then verified in clinical studies by couples in the Dominican Republic, South Africa, Thailand, and the United States. The single size should remove the need for a pelvic exam and fit assessment which are obstacles to both providers and women in many settings. PATH licensed the SILCS design to Kessel Marketing & Vertriebs GmbH of Frankfurt, Germany, who will introduce the device as the Caya™ contoured diaphragm.
While SILCS was developed to expand women’s options for nonhormonal barrier contraception, SILCS has added value due to its potential to be used as a multipurpose prevention technology when paired with tenofovir gel—a product currently in Phase III clinical testing—which is designed to protect women from acquiring HIV.
CONRAD, which owns a license for tenofovir gel, is working on a protocol for a study that will assess the safety, pharmacokinetics, and pharmacodynamics of the SILCS plus tenofovir gel. Another study will evaluate the potential of a modified tenofovir gel as a contraceptive by pairing it with the SILCS to assess their ability to prevent sperm from penetrating cervical mucus.
PATH is working with research partners in India, South Africa, and Uganda to identify opportunities and challenges for future introduction of the single-size diaphragm in developing countries. There are 222 million women worldwide who would like to avoid pregnancy but aren’t using a modern method of contraception. Some women are either unable or unwilling to use hormonal contraceptives, and many also have infrequent sex and prefer to use a product that is on demand and woman initiated.
Imagine a world where every child born is planned and their mothers are free of HIV infection. As Louis Armstrong sang, what a wonderful world this could be.
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