Researchers conducting clinical trials of diaphragm as HIV prevention method

Researchers at the Women's Global Health Imperative program at the University of California-San Francisco's Medical Center are conducting a large-scale clinical trial among 4,500 women in Zimbabwe and South Africa to test the effectiveness of diaphragms in preventing the spread of HIV, the Chicago Sun-Times reports.

The Bill and Melinda Gates Foundation has provided $28 million for the study. The diaphragm being studied in the trial, called SILCS, is under development by the Seattle-based PATH.

SILCS is a "one-size fits most" silicone device that likely will receive FDA approval and be available by 2010, according to the Sun-Times.

SILCS differs from the most widely used diaphragm, called Ortho All-Flex, because it does not require a woman to undergo a pelvic exam to be fitted with the correct size.

"Manufacturing processes have changed, materials have been updated, we know a lot more about vaginal anatomy now, so this is a good, simple technology that we could make significant improvements in," Maggie Kilbourne-Brook, a PATH program officer, said.

Preliminary findings of the Zimbabwe and South African study are expected to be released this summer, the Sun-Times reports.

"The world is waiting for the results," Kilbourne-Brook said, adding, "If it turns out that something as simple as a diaphragm ... could actually offer some protection from HIV, that's something that could get into women's hands very easily."

According to the Sun-Times, SILCS could prove to be "a powerful tool" in preventing the spread of HIV among women worldwide, particularly in Africa, where methods of protection that women can initiate without their partners' consent are needed, some experts and advocates have said (Schwartzapfel, Chicago Sun-Times, 2/25).