In-depth: Trials and Tribulations of HIV Prevention Research

SOUTH AFRICA: When microbicide trials go wrong - Part 2

Photo: Anthony Kaminju/IRIN

Street smart, articulate and well informed about their rights.

Durban, 12 October 2007 (PlusNews) - It's an overcast Thursday morning in the port city of Durban, on South Africa's east coast, and some of the former participants in a microbicide trial, discontinued earlier this year, have gathered at the now deserted research site behind a busy downtown taxi rank, to be interviewed by IRIN/PlusNews.

The trials of a microbicide candidate containing cellulose sulphate were stopped after preliminary results showed it could increase the risk of HIV infection.

CONRAD, a reproductive health research organisation, was carrying out the trials in Benin (West Africa), India, South Africa and Uganda, and is conducting more tests to find an adequate scientific explanation for the higher number of seroconversions (HIV infection) in the cellulose sulphate arm of the study.

In South Africa, public outrage over the results was heightened by sensational media coverage depicting the participants in microbicide trials as 'human guinea pigs', and alleging that the women were encouraged to visit bars and other similar places of entertainment, and to engage in unprotected sex.

Street smart, articulate and well informed about their rights, the six participants PlusNews spoke to are no 'guinea pigs'; they all emphasise the benefits of the gel, and how they were not "forced" to join the study. But they're also not really clear about why the trial was stopped, and all they want to know is, "When will the gel become available again?"

At the time the trial ended, Nokuthula Lefora, 37, was one month away from completing her 12 months of using the gel and really enjoyed using it, as it enhanced her sex life. "When you use it, you become aroused and moist and you feel good." Participants on the trial were required to insert the gel in the vagina an hour before sex, using an applicator, and to use it with a condom.

The married mother of four first heard the rumours in her informal settlement that a group of women were claiming to have been infected after using the potential prophylaxis. She subsequently received a telephone call from researchers at the Medical Research Council, alerting her to the premature end of the trial and telling her to stop using the gel and return it to the research site.

Then the news broke in the media. "When I heard about this on TV and radio, about women who were told to go to shebeens and have sex with a lot of men, I was confused; I thought, 'They can't be talking about my trial, because it didn't sound like the one I was on.'"

A presentation in July by the local researchers on why the microbicide trial had been discontinued doesn't seem to have convinced Lefora though, as she maintained that the women who seroconverted were "troublemakers" who became HIV-positive because they did not use the gel properly. She has recently been for an HIV test and is negative, and told IRIN/PlusNews that she would use the gel again - despite the fact that "it didn't pass".

What happened to the women?

When Nomusa (last name withheld) heard that the trial had been stopped, her initial reactions were fear and panic. Now, almost a year later, HIV negative Nomusa misses the regular health screening she received at the research centre, as well as the friends she made. The last time she had a PAP smear test was in 2006 during the trial, and she doubts she'll be able to have the test at her local clinic.

"Forget about the R150 they used to give us; it helped so many people to be on this thing. We got tested, and I know some of the women I came with found out they were HIV here. They are now getting help ... before we came here, some people didn't even know that condoms expire," she commented.

We started calling them immediately, and told them to stop using the gel and come to the clinic to bring it back ...and we even offered to send someone to pick it up.

At the offices of the Medical Research Council's (MRC) HIV Prevention Unit, which is responsible for several microbicide trials being carried out in South Africa, Dr Roshini Govinden, the principal investigator of the Durban cellulose sulphate trial, told IRIN/PlusNews that the participants were "disappointed" when the trial was halted.

"We started calling them immediately, and told them to stop using the gel and come to the clinic to bring [it] back ... and we even offered to send someone to pick it up," she said. "A lot of them did come back and we got all the product back ... except for one woman who was a little bit annoyed and accused us of trying to give her HIV. She never came back."

The partner of one participant burnt her gel supplies, while the male partners of women in other microbicide trials run by the MRC raised concerns that using "gel" increased HIV risk, and did not want them to participate in the trials.

Former participant Nelisiwe (not her real name), who had recruited other women to enrol in the study, found out the trial had stopped via phone calls and text messages from women she had encouraged to join. "They were asking me, 'Have you heard about your gel? They say it has HIV'".

Nelisiwe and her 22-year-old daughter, who also participated in the trial, had already finished their 12-month trial period by this time, and both are still negative. The six women interviewed by PlusNews were all HIV negative, and those who had seroconverted during the trial have been reluctant to speak to the media.

The standard of care for women who become HIV positive during microbicide trials is a hotly debated issue: should researchers be obliged to offer the best possible care, the standard of care in the host country, or something between?

According to Govinden, all the women who seroconverted during the trial have been referred to healthcare facilities, and HIV-positive participants can access free CD4 count and viral load tests, as well as treatment for opportunistic infections, at a nearby HIV/AIDS clinic supported by the US President's Emergency Plan for AIDS Relief (PEPFAR). She said the women also received intense counselling.

Ntokozo Madlala, advocacy officer for the Gender AIDS Forum, told IRIN/PlusNews that access to care for women who had seroconverted during trials was still a patchy issue, as there was "no uniform standard of care" and some research organisations offered better HIV care services than others. "It depends on who is funding it and sponsoring the trials," she said.

Read more on the trials and tribulations of HIV prevention research
What's in it for participants?
Vaccine trial volunteers
Community involvement - more than just window dressing?
When a microbicide trial goes wrong - Part 1

The Global Campaign for Microbicides has called on all trial sponsors to set up mechanisms to ensure that participants have access to HIV care before trials begin. Care is usually arranged in partnership with local facilities, or the creation of a reserve fund to pay for treatment.

Many trials also try to facilitate access to care for women who test HIV positive at screening, by providing CD4 tests and other tests that can help them qualify for local treatment programmes.

Keeping the momentum going

That there will be more trial failures cannot be ruled out. But it doesn't help that the country's AIDS activists have been slow to become involved with microbicides, and there are no "strong and visible" advocates and watchdogs for the potential prevention tool.

Madlala admitted that many NGOs have been "too relaxed" about closely following the microbicide research process, choosing instead to pursue "sexier and more urgent" issues, like treatment.

"I don't think you can be an activist and shut out issues looking into prevention for women," she said. "It's a pity, because the research field is moving at a very fast pace. South Africa is becoming the place for microbicide trials, but we as advocates need to get our act together, because some of us still don't know what a microbicide is, or how clinical trials work."

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Trials and Tribulations of HIV Prevention Research

October 2007

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