Dr. Nancy Padian, University of California, USA and colleagues representing Methods for Improving Reproductive Health in Africa (MIRA) did a randomised trial of around 5000 sexually active, HIV negative women in Southern Africa.

All the women were given a HIV prevention package, consisting of condoms, pre-test and post-test counselling about HIV and sexually transmitted infections (STIs), testing, treatment of curable STIs, and intensive risk-reduction counselling. Half of the women were additionally given diaphragms and lubricant gel, while the other half did not use diaphragms and formed the control group.

HIV incidence in the two groups was not significantly different. The diaphragm group had a HIV incidence of 4·1% per 100 woman-years, compared with 3·9% in the control group. The researchers noted that the proportion of women using condoms was significantly lower in the diaphragm group than in the control group (54% vs 85%). They say: "Our observation that lower condom use in women provided with diaphragms did not result in increased [HIV] infection merits further research."

The authors say: "We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were used in addition to condoms and a comprehensive HIV prevention package."

They conclude: "Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.

"Women who cannot convince their male partners to use condoms are still in urgent need of a female-controlled method of protection. In addition to research on methods that are inherently more efficacious, we must develop the instruments to allow assessment of even modest amounts of protection."

In an accompanying Comment, Dr. Ronald Gray and Dr Maria Wawer, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA, say: "Female-controlled methods of HIV prevention are urgently needed. Unfortunately, the only proven prevention methods in adults are controlled by men.

"Padian and colleagues did an innovative trial of an available technology, and the disappointing results must not discourage the testing of other novel approaches."


SOURCE: The Lancet

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