Women Using Latex Diaphragm With Condoms Had Same HIV Incidence as Those Who Only Used Condoms, Study Says

Women who used latex diaphragms and condoms as an HIV prevention method had the same HIV incidence as those who only used condoms, according to a study published online on Thursday in advance of the July 14 issue of the journal Lancet, the Wall Street Journal reports (Chase, Wall Street Journal, 7/13).

For the study -- funded by a $37 million grant from the Bill & Melinda Gates Foundation -- Nancy Padian of the University of California-San Francisco and colleagues enrolled nearly 5,000 women ages 18 to 49 in Durban and Johannesburg, South Africa, and in Harare, Zimbabwe. The researchers followed the study participants for an average of 18 months, the San Francisco Chronicle reports. Half the participants were given diaphragms, gel lubricant and condoms, while the other half were provided with condoms only. Both groups also received extensive counseling on condom use, the Chronicle reports.

The study found that HIV incidence between the two groups was almost identical, with about 4% of women in both groups becoming HIV-positive annually. According to the study, 158 women who were given diaphragms, lubricant, condoms and counseling became HIV-positive and 151 women who were given condoms and counseling became HIV-positive. Padian said one of the more disappointing and surprising results was that women given diaphragms reported using them 70% of the time. The same group of participants also reported that their partners used condoms 54% of the time, compared with 85% condom usage in the group given condoms only. The almost identical HIV incidence between the two groups might suggest that diaphragm use is at least as effective as condoms at preventing HIV, but because the trial was not designed to compare the two methods, there is no proof of equivalence, Padian said (Russell, San Francisco Chronicle, 7/13).

The study's findings should be investigated further, but they do not "warrant using [diaphragms] as a protective mechanism now," Padian said (Russell, San Francisco Chronicle, 7/13). She added, "Condoms remain the only proven barrier method for HIV prevention" (Reuters, 7/12).

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"It's very, very disappointing, of course," Padian said, adding, "We were hoping to find a protective effect" (San Francisco Chronicle, 7/13). The study's findings are especially disappointing for women "who still can't negotiate condom use by men," Padian said. Women worldwide urgently need HIV prevention methods they can control, an accompanying Lancet opinion piece said (Wall Street Journal, 7/13).

Nick Hellmann, interim director of HIV/AIDS and tuberculosis at the Gates Foundation, said although the results of the study are disappointing, they are simply part of the scientific process. He added that the findings will not deter the Gates Foundation from continuing to fund for research in the field. "There have been setbacks, but we know we can do this," Hellmann said, adding, "It's a matter of finding the right intervention."

Zeda Rosenberg, CEO of the International Partnership for Microbicides, said the study provides valuable information for future investigations into such products. "These studies are incredibly difficult to do, but it is a difficulty that can and must be overcome," she said, adding, "Women are at high risk of [HIV] infection throughout the world, and they don't have a means of protecting themselves under their control" (San Francisco Chronicle, 7/13).

The study is available online.