South Africa: trials test efficacy of diaphragms in preventing HIV/AIDS

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Studies are being carried out in South Africa and Zimbabwe to determine whether diaphragms can help protect women against HIV/AIDS, as they bear the brunt of the pandemic.

To prove the effectiveness of diaphragms in HIV-prevention, US-based research institute Ibis Reproductive Health has initiated a number of trials in Southern Africa, called Methods for Improving Reproductive Health in Africa (MIRA).

Health experts have stressed that diaphragms would not be able to completely eliminate the risk of HIV infection.

Glossary

concentration (of a drug)

The level of a drug in the blood or other body fluid or tissue.

perinatal

Relating to the period starting a few weeks before birth and including the birth and a few weeks after birth.

gynaecology

Study of medical conditions specific to women's reproductive organs.

control group

A group of participants in a trial who receive standard treatment, or no treatment at all, rather than the experimental treatment which is being tested. Also known as a control arm.

cervix

The cervix is the neck of the womb, at the top of the vagina. This tight ‘collar’ of tissue closes off the womb except during childbirth. Cancerous changes are most likely in the transformation zone where the vaginal epithelium (lining) and the lining of the womb meet.

Medical evidence shows that the cervix has a high concentration of HIV receptors and may be the primary point of entry for HIV and sexually transmitted infections (STIs). Researchers believe that protecting it with a diaphragm to serve as a barrier could reduce rates of HIV and STI transmission.

The MIRA study started in October 2003 at four research sites, including the medical school of the University of Harare, Zimbabwe, the perinatal clinic of Chris Hani Baragwanath Hospital in Soweto near Johannesburg, and two venues in Durban, South Africa.

The Medical Research Council (MRC) of South Africa is conducting trials at two sites - Umkomaas on the south coast of KwaZulu-Natal province and in the semi-rural Bothas Hill area, 30km inland from Durban.

A total of 5,000 HIV-negative, sexually active women between 19 and 49 years are participating in the trials, half of whom will be randomly selected to receive a diaphragm and lubricant gel.

All participants are diagnosed and treated for STIs, receive counselling and free male condoms, and are tested for HIV every three months.

Researchers are assessing whether women using the diaphragms and lubricant gel have lower rates of HIV or other STIs than the control group. They are also investigating the long-term acceptability of diaphragms by women.

"We are expecting to have [our] first results by early 2007," said Ibis Reproductive Health MIRA project manager Naomi Lince in Johannesburg.

According to the MRC's MIRA principal investigator, Gita Ramjee, preliminary results have shown that "women like using diaphragms". Unlike female condoms, women could use diaphragms without the knowledge of their partners, which was particularly important in situations where they were unable to negotiate safer sex.

"The biggest downfall in acceptability of the female condom is that it is visible," Ramjee noted.

Finding alternative methods to protect women from HIV transmission was crucial, as promotion of condom use seemed to have had little effect, Ramjee noted.

The main drawback was that diaphragms were not freely available in family planning clinics and had to be prescribed by a gynaecologist. Cost also put them out of reach to most South African women, who would have to pay between US $16 and $31 for a diaphragm and US $9.40 - $11 for lubricant gel.

Nevertheless, the purchase of a diaphragm is almost a once-off cost, as the product lasts about two years.