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Forgotten contraceptive life-saver for African women

The AIDS epidemic in Africa is worsened by male attitudes to safe sex, reflected in their reluctance to use condoms. Women may have to do it for themselves – using diaphragms.

Nearly two decades into the AIDS pandemic, a four-year scientific trial in Zimbabwe and South Africa is set to launch long-due investigations into whether the diaphragm – a female-controlled contraceptive device – reduces women's risk of HIV infection.

The urgency of this study, starting in July, is underlined by recent United Nations figures showing that women make up 58 per cent of those infected with HIV in sub-Saharan Africa, with young women six times more likely than young men to be infected.

With a one in three chance that her partner is infected with HIV, a woman in Zimbabwe must hope that he will agree to use condoms: a male-controlled device.

The harsh reality is that for African women negotiating condom use – especially with long-term partners – can dangerously backfire. Most men control sexual decision-making, and many refuse, categorically, to use condoms. In extreme cases, women can be accused of infidelity, beaten or raped for suggesting their use.

Studies in 15 sub-Saharan countries have shown that condoms were used in less than 10 per cent of the last act of sexual intercourse between co-habiting or marital couples, but in significantly more – 40 per cent in Zimbabwe – during casual or commercial sex acts.

Although the female condom – a woman-initiated prevention – is now available, it still requires a partner's cooperation, and can provoke hostility. Also, for most women in developing countries, the cost of the one-time-only female condom is prohibitive.

By contrast, the diaphragm is undetectable and can be easily inserted up to six hours before intercourse and left in place for another 24 hours. A low-cost, reusable device, a personally fitted diaphragm costs about US$25. An experimental one-size-fits-all version will cost even less. With proper care, a diaphragm can be used for up to two years.

If proven effective in reducing new HIV infections, the diaphragm could save the lives of millions of women who currently cannot protect themselves.

The idea that the simple, low-tech latex diaphragm could reduce HIV infection by roughly 30 per cent – the same reduction attributed to the sought after, elusive AIDS vaccine – is not a new one.

In 1989 US virologist Dr Jay Levy, of the University of California, San Francisco AIDS Research Institute (ARI), began urging the research community to investigate the device after studying the transmission of HIV from men to women. His team established that a woman's cervix [the lower opening of the uterus] is particularly susceptible to HIV.

"I felt certain that if you could block virus-infected cells [in semen] from the cervix, you could reduce transmission dramatically," he said.

Unfortunately, Levy's call fell on deaf ears due to the unchallenged assumption among other experts – and aid agencies like the US National Institutes of Health (NIH) – that African women would not use diaphragms because current guidelines state that women need to be individually examined and measured by a clinician to determine their diaphragm size. The concern that fittings are time-consuming and may be embarrassing for provider and client led to the belief that diaphragm use presented too many obstacles.

According to Levy, research into the diaphragm "was too simple for the NIH to sponsor. The Gates Foundation listened and agreed to give it its day in court," he told the American Foundation for AIDS Research.

In fact, few African women are familiar with the device, which is rarely offered and has been largely supplanted as a contraceptive by hormonal methods such as the pill.

But scientists and donors are listening up, thanks to the determination of Dr Nancy Padian, ARI's director of international programmes, and her Zimbabwean collaborator Dr Tsungai Chipato, who presented compelling evidence that African women are willing to use the diaphragm at the 2002 Barcelona International AIDS Conference.

Chipato, a male obstetrician/gynaecologist at the University of Zimbabwe, told the Barcelona delegates that in a programme to encourage and teach condom use, he found that 98 per cent of 156 Zimbabwean women whose partners did not or would not use condoms were willing to use the diaphragm as an alternative – though untested – method of HIV protection. Only 1 per cent of the women had ever used a diaphragm before.

According to Padian, African women are "desperate to use something of hypothetical effectiveness that they can control [rather] than nothing at all."

The study finally paid off. After eight years trying and failing to interest major donors in diaphragm research, Padian's proposed diaphragm efficacy trial in southern Africa received $28 million from the Bill and Melinda Gates Foundation.

All the women in the study will have access to condoms and counselling to help them encourage their partners to use them. For comparison, half the women will be given diaphragms; the other half will not.

Diaphragms have firm but flexible rims and shallow domes which can be coated with spermicides, which inactivate sperm and prevents pregnancy, before insertion. They may reduce the risk of HIV transmission directly by preventing HIV infection or indirectly by protecting the cervix from other sexually transmitted infections (STIs) which are known to facilitate HIV transmission.

Chipato is eager to dismiss the old arguments about African women and diaphragms, noting that most women who might use the diaphragm have already given birth and would be familiar with such examinations from ante-natal visits.

According to Mavis Kamba, a nurse who worked with Chipato, it took most women less than two minutes to remove the diaphragm and re-insert it.

"There is no embarrassment about diaphragms," Chipato insists. "You could call it a forgotten method," he says adding that though many health providers say women do not like diaphragms, "it is clinicians who don't talk about them."

One Zimbabwean couple enrolled in Chipato's study were willing, albeit a bit shy, to talk about their experiences.

"I think it is safe from side effects [of hormonal contraceptives], but most important it is an alternative to the condom," said Chengetai, a Harare commuter bus driver. "If I get home too drunk to wear the condom, my wife can use the diaphragm."

His wife Chipo, a vegetable vendor, agreed. "My husband never knew I was wearing the diaphragm for a long time. I only told him recently and luckily he did not object."

While the diaphragm may never offer the same degree of protection against HIV as consistent condom use (estimated at 90-95 per cent efficacy rate), convincing men to use condoms has been a major stumbling block.

"I don't think we are going to prevent HIV [until] we get a method that women control and use without having to fight with their husbands," Chipato adds.

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Panos London

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06/25/2003

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