Mail & Guardian Online - July 14, 2007
Belinda Beresford

It is now estimated that 2,47-million people out of India's more than 1,1-billion population have HIV, down from 5,7-million previously. An estimated 5,5-million South Africans carry the virus out of a total population of approximately 47-million.

The estimates for India were slashed following a survey of HIV infection levels among a group of people representative of the entire population. The previous estimate of 5,7-million people had been based on surveillance of women attending ante-natal facilities and high-risk population groups.

But efforts to curb the spread of HIV received a setback this week with the announcement that a large clinical trial in South Africa and Zimbabwe had found that using a diaphragm did not appear to protect women against HIV infection.

Diaphragms are rubber disks used as a contraceptive in conjunction with a lubricating spermicide. Previous studies had suggested that by covering the cervix, diaphragms help protect women against sexually transmitted diseases. The cervix is particularly vulnerable to HIV because it contains a high number of the cell types which HIV is best at attacking and has a thinner protective layer than the vagina.

The hope was that the diaphragm, which is a widely accepted, long used, simple, and low-cost measure not surrounded by costly issues such as patents, could provide a readily available female controlled prevention method. But, as the Mira (Methods for Improving Reproductive Health in Africa) researchers write in a paper published in the Lancet: "Unfortunately, our results add to the growing body of HIV-prevention trials that have failed to show a protective effect of interventions. To date, of 25 randomised controlled trials for HIV prevention, four have shown a protective effect (three trials of circumcision and one trial of treating STIs to prevent HIV), whereas 19 showed no effect."

The Mira trial had involved more than 5 000 women in Soweto, Durban and Harare over a three-year period. At the beginning of the trial in 2003, 39% of potential participants in Durban and 19% of those in Soweto tested HIV-positive. All participants in the trial were given ongoing counselling and testing on HIV, treatment for sexually transmitted diseases and access to condoms. Half the women were randomly assigned to the intervention group and received diaphragms and lubricants as well as condoms.

Since a "placebo diaphragm" doesn't exist, this was an open-label trial, with researchers and participants both knowing who was in the intervention group -- and one of the results was that women using diaphragms were less likely to use condoms as well, even though counselled to do so. One of the principal investigators, Guy de Bruyn of the Perinatal HIV Research Unit of the University of the Witwatersrand, says that overall condom use among participants in the trial increased due to intensive and repeated counselling, but that the increase was higher among women in the control group than among those using diaphragms.

Despite this, the rate of new HIV infections in the two groups was statistically the same. This may either have been because the diaphragm did have some protective effect or because women in the control group were more likely to over-report their use of condoms.

De Bruyn said he was disappointed that, based on the results of this trial, the diaphragm could not be recommended as a public health measure against HIV. "The goal is to try and find some method that can offer women methods they can control. It's disappointing that we weren't able to do that. Fortunately there are other studies that may yield that elusive goal."

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