Some 2 500 women who tested a seaweed-based vaginal gel to see whether it can offer protection against HIV are eagerly awaiting the results of the trial, expected in January.
The microbicide gel, which can be inserted an hour before sex, was tested by women in Durban, Tshwane and Cape Town in a trial run by the Population Council, an international non-profit organisation.
‘We will be very disappointed if it doesn’t work. But what we already know is that it is neither harmful nor 100% effective because in either case, we would have stopped the trial,’ says Dr Neetha Morar, principal investigator for the site at Isipingo in Durban.
‘But even if it is 30% effective, it will offer some protection for women who find it difficult to insist that their partners use condoms,’ she adds.
Dr Khatidja Ahmed, principal investigator of the trial in Soshanguve in Tshwane, says the beauty of the microbicide, called Carraguard, is that it is derived from a natural substance.
‘Carraguard is made from a seaweed product called Carrageenan, which is very widely available and has been used in a lot of other formulations. It’s been used in creams, food products,’ says Ahmed.
It’s been classified by the Food and Drug Administration as being a generally safe product for use. The product Carraguard, is now a formulation of Carrageenan in a vehicle like a gel to make it accessible to insert into the vagina.’
The trial was to test whether the gel could act as a barrier to prevent the HI virus from an HIV positive man from entering his partner’s vaginal wall.
All the women taking part in the trial had to be HIV negative. They were counselled on the importance of using the gel with condoms and investigators took great pains to explain that there was no evidence that it works to prevent HIV.
‘The women were between 16 and 40 years of age, but the average age was 35,’ says Dr Thesla Palanee, senior scientist at the Isipingo site.
‘We recruited women on the streets, just going up and talking to them. They were then given group and individual counselling and HIV and pap smear tests. Women who were HIV positive, had signs of cervical cancer or were pregnant were excluded from the trial, but referred to local health facilities,’ said Palanee.
Those recruited were either given the active gel or a placebo, but neither the women nor the researchers knew who was getting Carraguard ‘ in scientist lingo, this made it a randomised double-blind trial.
Preparations for the trial started in 2004 and the actual trial began last year. However, it was destabilised by the news earlier this year that another microbicide trial of a substance called cellulose sulphate had been called off. This was researchers found that there was a high incidence of HIV in women using the active gel than those getting the placebo.
According to the research body conducting that trial, CONRAD, this could be because the cellulose sulphate either caused an inflammatory reactions, or disrupted the normal vaginal flora.
The news caused a media frenzy, with stories that black women were being used as ‘guinea pigs’ and health minister Dr Manto Tshabalala-Msimang ordered an investigation into the trial.
‘We had to explain to our participants that there was no connection between the cellulose sulphate trial and Carraguard,’ says Palanee.
Trial participants in Durban said the news of the failure of the cellulose sulphate trial had a negative effect on them.
‘We were very angry about the media coverage that we were being used as these guinea pigs, that we had been bought by money to take part in the trial and that we were selling our blood for money,’ said Thokozile Lembede.
‘They said black people are so poor we can be bought to join a clinical trial. But I am not so poor I can sell myself for the R150 we got for transport.
We know what we are doing,’ said Lindiwe Ngenge, widening her big eyes in anger.
‘I, as Bawinile, don’t need the R150. They are sick. I know what I am doing,’ said Bawinile Ngcobo.
All the trial participants interviewed said they agreed to join the trial primarily because they wanted to know their health status and were attracted by the regular health services being offered, including tests for sexually transmitted infections, pregnancy tests, family planning services and pap smears.
‘When I joined, I didn’t know my HIV status. I had never taken a test before. By being part of the trial, I learnt things to prevent HIV and I can go and tell others how to stop getting it,’ said Khanyisile Cele.
‘We were always told to use condoms with the gel. At first, my partner had a problem. We weren’t using condoms and it was hard but I persuaded him to use condoms,’ said Lembede.
‘Sometimes we use the condoms and the gel and sometimes just the gel. My partner found the gel very hot,’ laughs Cele.
Like the scientists, the trial participants are impatiently awaiting the results: ‘It will be great to have helped to test something that works,’ says Cele.
The clinical trials were conducted by the University of Limpopo/Medunsa at the Setshaba Clinic in Soshunguwe, the University of Cape Town at Gugulethu and the Medical Research Council (MRC) at the Isipingo Clinic in Durban.