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CAPE TOWN — For Xoli Mthethwa, an unmarried 26-year-old mother of one living in semi-rural Vulindlela near Pietermaritzburg, the first trial of an AIDS gel using a prescription drug was a matter of life and death.
Mthethwa was one of 889 women at high risk of infection who took part in the clinical trials of the new gel.
The first results, released at an international AIDS conference in Vienna, show it can protect women from the deadly virus though not at the rates researchers had hoped for.
Mthethwa told Reuters from her home in Vulindlela, “Since males don’t like to use condoms and it is difficult for women to persuade them to use it, if this gel is successful it will help many women because they will not have to ask for permission to use the gel and many women will be able to protect themselves from HIV.”
The gel can be used discreetly, offering women a chance for protection from sexual partners who refuse to wear condoms, which experts say is one of the drivers of the spread of HIV and AIDS on the continent.
Each participant needed to apply a first dose of the gel within 12 hours before sexual intercourse, with a second dose applied as soon as possible and within 12 hours afterwards.
Dr Salim Abdool Karim at the University of KwaZulu-Natal in Durban and colleagues have been testing the gel for two-and-a-half years on two groups of women — city-dwellers in Durban and women like Mthethwa living in rural settlements.
He wanted to find out not only if the gel can biologically protect women, but whether women will use it, and if their sexual partners will let them.
About 60% of new infections in Africa, at the epicentre of the AIDS pandemic, are in women and girls, who often struggle convincing male partners to use condoms to protect them from infection from the virus that has killed more than 25 million people since emerging during the 1980s.
“You think about a young woman who is going steady with an older man, wants to have his child,” Karim said in a telephone interview.
“She is faithful to the man, but she is faithful to the very man who is going to give her HIV. It is very difficult for a young woman to get an older man to use condoms.”
The AIDS virus is passed in blood, breast milk and on contaminated needles, but by far the most common means of transmission is during sexual intercourse.
Earlier trials involving microbicides have failed.
The study Mthethwa has been taking part in gives the first indication that adding anti-AIDS drugs — in this case tenofovir— to the gels can make them worthwhile.
Karim said 98% in the study liked it, a strong sign it will be used widely, while almost none of the sexual partners of these women had any objections.
“At first we (my friends and I) were worried because we weren’t sure if use could have an effect in the vagina, but nothing happened so we were fine,” Mthethwa said.
Mthethwa said the gel did not diminish sexual experience, an important factor for many males who often refuse to use condoms because of perceptions they reduced sexual pleasure.
Spurred on by mounting deaths, mainly among young adults, the traditional leaders at Vulindlela partnered with health workers to try and halt the advance of AIDS in a community already struggling with high unemployment and low literacy rates.
“There were many funerals — between six and eight — over a weekend. Then the weekends became too short and we were burying during the week,” said Gethwana Mahlase, a community worker involved in the Vulindlela trial.
Dr Janet Frohlich, the Vulindlela site director, said the epidemic in the village was reflecting trends across sub-Saharan African countries, such as Kenya, Malawi, Lesotho and Cameroon, by hitting young women hardest.
“The importance of being able to develop a technology for women to prevent infections is absolutely critical,” Frohlich said. — Reuters.
THE gel was tested under tight ethical guidelines among 889 women in urban and rural South Africa, who were HIV-free at the start of the project.
Half of the women received the cream — the first microbicide to contain an anti-retroviral drug commonly used to treat HIV-infected people — while the others used a placebo, a harmless but non-active lookalike.
Thirty-eight women in the gel group became infected with HIV, compared with 60 in the placebo group.
In statistical terms, the gel reduced the risk of HIV infection by 39% overall, but by 54% among women who adhered to the instructions most consistently.
There was no increase in side effects, nor — among women who became infected with HIV — any sign that they were more resistant to tenofovir as a result of the gel.
Researchers are already working on another larger trial, which will involve 5 000 women in South Africa, Malawi, Uganda and Zimbabwe, to further test the gel’s safety and efficacy.